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  1. DDW Study Sees Better Outcomes With Multidisciplinary Approach to Functional GI Disorders Many patients say their functional gastrointestinal disorders improve with a combination of adjunctive strategies, including dietary changes and biofeedback. Now they have some rigorous evidence to back up those beliefs. A prospective randomized trial found that a multidisciplinary approach “was superior for global symptoms, improvement in specific functional symptoms, psychological state, quality of life, and cost” to care from a gastroenterologist alone, said Chamara Basnayake, MBBS, a consultant gastroenterologist at St. Vincent’s Hospital, in Melbourne, Australia, who led the research. When specialists collaborated, 84% of patients met the primary end point of global symptom improvement, compared with 57% of those managed by standard care, according to the researchers (P<0.001). With a more rigorous definition of “much better”—a score of 5 on a 5-point Likert scale—the proportions were 51% versus 28% (P=0.01), they said. View the full article Copyright © 2004-2020 McMahon Publishing unless otherwise noted.
  2. DISTINCT BRAIN-GUT MICROBIOME ALTERATIONS IN FEMALE IBS SUBJECTS: AN ANALYSIS OF FUNCTIONAL BRAIN NETWORKS AND FECAL AMINO-ACID METABOLITES Author(s): Vadim Osadchiy1, Emeran A. Mayer1, Kan Gao1, Jennifer S. Labus1, Bruce D. Naliboff1, Lin Chang1, Jonathan P. Jacobs1, Arpana Gupta1 Background: Evidence from preclinical and clinical studies suggests that alterations in brain-gut-microbiome (BGM) interactions play an important role in the pathogenesis of irritable bowel syndrome (IBS). Here, we use a systems biology approach, leveraging neuroimaging and fecal metabolite data to characterize these BGM interactions. Methods: Fecal samples and resting state fMRI imaging were obtained from 138 female subjects (99 IBS, 39 healthy controls (HCs)). Partial least squares discriminant analysis (PLS-DA) was conducted to explore group differences. Metabolites and brain regions with values of the first principal component of variable interest in PLS-DA greater than 1.0 were assessed by Student’s t-test. We then performed partial correlation analysis between significantly changed metabolites and neuroimaging data. All correlational tests were performed controlling for age, BMI, and diet; results are reported after FDR correction, with q<.05 as significant. Results: Compared to HCs, IBS showed increased connectivity of the putamen with the default mode and somatosensory networks. Metabolite pathways involved in nucleic acid and amino acid metabolism differentiated the two groups. Only a subset of metabolites (Figure 1), primarily amino acids, were associated with IBS-specific brain changes, including tryptophan, glutamate, and histidine. Histidine was the only metabolite positively associated with both IBS-specific alterations in brain connectivity. Conclusions: Our findings suggest a role for several amino acid metabolites in modulating brain function in IBS. These metabolites may alter brain connectivity directly, by crossing the blood-brain-barrier, or indirectly through peripheral mechanisms. Previous work in IBS subjects has demonstrated that the gut microbiota can impact visceral sensitivity through alteration of putamen connectivity. This is the first study to integrate both neuroimaging and fecal metabolite data supporting the BGM model of IBS, building the foundation for future mechanistic studies into the influence of gut microbial metabolites on brain function in IBS. Funding: K23 DK106528 (AG), ULTR001881/DK041301 (UCLA CURE/CTSI Pilot and Feasibility Study; AG), P50 DK064539 (EAM), R01 DK048351 (EAM), and pilot funds provided for brain scanning by the Ahmanson-Lovelace Brain Mapping Center. Disclosure: V. Osadchiy: No Conflicts; E. A. Mayer: Amare: Board Membership; Axial Biotherapeutics: Board Membership; Bloom Biosciences: Board Membership; Danone: Board Membership; Mahana: Board Membership; Pendulum: Board Membership; Ubiome: Board Membership; K. Gao: No Conflicts; J. S. Labus: No Conflicts; B. D. Naliboff: No Conflicts; L. Chang: Allergan: Consulting; Arena Pharmaceuticals: Advisory Committees or Review Panels; IM Health Sciences: Consulting; Ironwood Pharmaceuticals: Advisory Committees or Review Panels; MetaMe: Stock Shareholder; Modify Health: Stock Shareholder; OrphoMed: Advisory Committees or Review Panels; Rome Foundation: Other Activities Not in List ; Salix: Speaking and Teaching; Shire Takeda: Advisory Committees or Review Panels, Speaking and Teaching; J. P. Jacobs: Prolacta Biosciences: Consulting; A. Gupta: No Conflicts;
  3. ASSOCIATION OF FECAL MICROBIOME WITH RESILIENCE IN IRRITABLE BOWEL SYNDROME PATIENTS COMPARED TO HEALTHY CONTROLS Author(s): Wendi LeBrett1, Swapna Mahurkar-Joshi1, Jennifer S. Labus1, Bruce D. Naliboff1, Arpana Gupta1, Jonathan P. Jacobs1, Kirsten Tillisch1, Lisa A. Kilpatrick1, Emeran A. Mayer1, Lin Chang1 Introduction: Evidence supports that irritable bowel syndrome (IBS) is a disorder of brain-gut microbiome interactions that affect the community structure and function of the gut microbiota and may modulate gastrointestinal function. IBS patients have been shown to have decreased resilience compared to healthy controls (HCs). While the association between the microbiome and resilience has been studied in animal models, it remains understudied in humans, including IBS patients. The aim of this study is to compare microbial composition between IBS and HCs with high and low resilience measured by the Brief Resilience Scale (BRS). BRS scores have been shown to be significantly lower in IBS vs. HCs. Methods: 329 subjects (160 IBS, 169 HCs) completed questionnaires to measure resilience (BRS) and diet and provided stool samples. Subjects with BRS scores > 66thpercentile (BRS >24) were considered “high resilience” and subjects with BRS scores < 33rdpercentile (BRS <20) were considered “low resilience”. 16S rRNA gene sequencing was performed and analyzed with QIIME, Phyloseq and DESeq2 packages in R. Associations between resilience and rarefied relative abundance data were analyzed controlling for age, diet, BMI and neuroticism as they can affect resilience and/or fecal microbiome. Results: The final study population included 102 IBS (71% female, IBS-C 27%, IBS-D 42%, IBS-M 24% and IBS-U 7%) and 89 HCs (70% female). 29 IBS and 56 HCs were in the “high resilience” group and 73 IBS and 33 HCs were in the “low resilience” group. IBS subjects with high resilience had significantly lower alpha diversity than HCs with high resilience (p=0.01, Fig 1) and IBS subjects with low resilience (p=0.02). Beta diversity did not differ between high and low resilience subjects for both IBS (p=0.13) and HCs (p=0.14). However, there were significant differences in microbial composition between the high and low resilience groups within the IBS and HC groups (Table 1). In IBS patients with low resilience, there was a decreased abundance of Firmicutes Bacillus, which has also been shown to be decreased in stressed mice. In HCs with low resilience, abundance of Bacteroidetes Prevotella was increased and has also been shown to be increased in women with early life stress. Firmicutes Clostridium, which is more abundant in animal models of stress, was increased in high resilience HCs but lower in high resilience IBS subjects. Conclusion: Resilience is associated with changes in microbial richness and composition in IBS that is distinct from HCs, suggesting that a resilience-associated microbial signature is influenced by IBS disease status. Further studies should focus on the role of these microbes in IBS pathophysiology. However, there are likely other interacting factors, e.g. current level of stress, stressful life events, that contribute to the microbial profile in IBS. Disclosure: W. LeBrett: No Conflicts; S. Mahurkar-Joshi: No Conflicts; J. S. Labus: No Conflicts; B. D. Naliboff: No Conflicts; A. Gupta: No Conflicts; J. P. Jacobs: Prolacta Biosciences: Consulting; K. Tillisch: No Conflicts; L. A. Kilpatrick: No Conflicts; E. A. Mayer: Amare: Board Membership; Axial Biotherapeutics: Board Membership; Bloom Biosciences: Board Membership; Danone: Board Membership; Mahana: Board Membership; Pendulum: Board Membership; Ubiome: Board Membership; L. Chang: Allergan: Consulting; Arena Pharmaceuticals: Advisory Committees or Review Panels; IM Health Sciences: Consulting; Ironwood Pharmaceuticals: Advisory Committees or Review Panels; MetaMe: Stock Shareholder; Modify Health: Stock Shareholder; OrphoMed: Advisory Committees or Review Panels; Rome Foundation: Other Activities Not in List ; Salix: Speaking and Teaching; Shire Takeda: Advisory Committees or Review Panels, Speaking and Teaching;
  4. HIGH STRESS REACTIVITY IS ASSOCIATED WITH SHIFTS IN IBS PHENOTYPE AND MICROBIOME COMPOSITION/FUNCTION Author(s): Jonathan P. Jacobs1,2,3, Venu Lagishetty1, Cathy Liu1,2, Jennifer S. Labus1,2, Lin Chang1,2, Arpana Gupta1,2, Kirsten Tillisch1,2,3, Emeran A. Mayer1,2 Background and Aims: Irritable bowel syndrome (IBS) is associated with perturbation of the brain-gut-microbiome (BGM) axis including alteration of CNS structure/connectivity, visceral sensitivity, and gut microbiome composition/function. We hypothesized that heightened reactivity to stressors would affect IBS phenotype and the gut microbiome due to altered BGM signaling including increased adrenergic output to the GI tract. Methods: Two psychological instruments – perceived stress scale (PSS) and international personality item pool neuroticism (IPIP) – were utilized to assess reactivity to stress and emotional situations. Responses from 364 subjects, including 188 IBS patients and 176 healthy controls (HC), were clustered by partitioning around medioids. Fecal samples were collected for analysis of microbial composition and function by 16S rRNA sequencing (n =166 IBS, 161 HC), metatranscriptomics (Viome; n=94 IBS, 91 HC), and metabolomics (Metabolon; n=107 IBS, 157 HC). Differentially abundant microbes (97% operational taxonomic units), transcripts (KEGG orthology), and metabolites were identified by multivariate models incorporating sex, race, age, obesity, and bowel habit subtype with significance threshold FDR<0.1. Differential features were used to construct random forests classifiers. Results: PSS and IPIP were highly correlated (r=0.66) and together could be used to define two clusters, one with heightened stress reactivity and the other with low reactivity. IBS was enriched in prevalence of the high stress reactivity cluster (65% vs. 38% in HC, p=4x10-7). The high stress reactivity cluster was associated with increased IBS severity (mean IBS-SSS 236 vs. 207, p=0.02) and reduced frequency of the diarrhea-predominant BH subtype (34% IBS-D vs. 51% IBS-D, p=0.03). High stress reactivity was associated with differential abundance of 42 gut microbes including depletion of 11 members of Bacteroides and 3 Parabacteroides; altered levels of 16 transcripts including reduced levels of neurotransmitter sodium symporter (NSS); and reduced glutamate, glutamate gamma-methyl ester, and cysteine S-sulfate (NMDA glutaminergic agonist). Random forests classifiers for high stress reactivity constructed from microbial abundances or a combination of microbes, transcripts, and metabolites had AUROC of 0.64 and 0.71, respectively. Glutamate and NSS were in the top 8 features by importance score. Conclusions: High stress reactivity in IBS is associated with greater severity and reduced diarrhea-predominance. It has a gut microbiome signature characterized by reduced levels of Bacteroides and Parabacteroides and functional alterations in neurotransmitter pathways. These microbiome changes may reflect altered top-down signaling from the brain that contributes to symptom generation, and/or microbiome signaling to the brain may contribute to increased stress reactivity Disclosure: J. P. Jacobs: Prolacta Biosciences: Consulting; V. Lagishetty: No Conflicts; C. Liu: No Conflicts; J. S. Labus: No Conflicts; L. Chang: Allergan: Consulting; Arena Pharmaceuticals: Advisory Committees or Review Panels; IM Health Sciences: Consulting; Ironwood Pharmaceuticals: Advisory Committees or Review Panels; MetaMe: Stock Shareholder; Modify Health: Stock Shareholder; OrphoMed: Advisory Committees or Review Panels; Rome Foundation: Other Activities Not in List ; Salix: Speaking and Teaching; Shire Takeda: Advisory Committees or Review Panels, Speaking and Teaching; A. Gupta: No Conflicts; K. Tillisch: No Conflicts; E. A. Mayer: Amare: Board Membership; Axial Biotherapeutics: Board Membership; Bloom Biosciences: Board Membership; Danone: Board Membership; Mahana: Board Membership; Pendulum: Board Membership; Ubiome: Board Membership;
  5. GASTROENTEROLOGISTS’ PRESCRIBING PATTERNS AND COMFORT-LEVEL VARY ACROSS DIFFERENT CLASSES OF CENTRAL NEUROMODULATORS FOR TREATMENT OF IBS Author(s): Wendi LeBrett1, Benjamin Nulsen1,Douglas Drossman2, Lin Chang1 INTRODUCTION: Central neuromodulators (CN) are increasingly being recommended for treatment of IBS. However, gastroenterologists (GIs) may not be fully familiar with their different mechanisms of action and side effect profiles, and may vary in their comfort level when prescribing them. Therefore, we administered a survey of GIs to compare variations in prescription patterns and their comfort levels when treating IBS patients using different CN. METHODS: We administered a 23-question survey to GIs in the United States via email and at local and national GI meetings. GIs were asked about their usage and attitudes towards prescribing various CN: tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), anxiolytics, and antipsychotics when treating patients with IBS. For each class of CN, GIs were asked to provide the percentage of IBS patients that they prescribed that class of medication and their comfort level prescribing it. Descriptive statistics and Cochran-Armitage tests were used to compare characteristics of “high prescribers” of each medication class (defined as those who prescribed above the median % of their IBS patients, i.e. >70% for TCAs and >10% for all other classes). Logistic regression was used to identify factors associated with increased comfort with prescribing each medication class. RESULTS: There were 322 survey respondents, 32 responses were excluded for incomplete data, therefore we analyzed 290 survey responses in our study. Among the 290 respondents, 63% were male, 57% practiced in the community, and 85% were in practice for ≤30 years (Table 1). GIs seeing a higher percentages of IBS patients were more likely to be high prescribers of antipsychotics (p = 0.03) and anxiolytics (p = 0.01), but not TCAs, SSRIs or SNRIs. Years in practice was not associated with high prescribers of any class of CN. Except for prescribing anxiolytics (p=0.26), high prescribers of all other classes of CN were more likely to have high self-assessed competence on a 5-point Likert scale. Only 14% of GIs felt comfortable prescribing antipsychotics. In comparison, many GIs felt comfortable prescribing other types of CN (TCAs 88%, SSRIs 62%, SNRIs 47%, and anxiolytics 48%). Comfort with using CN to treat psychiatric symptoms was associated with increased comfort with prescribing SSRIs (OR 6.9, 95% CI 3.2 – 14.7), SNRIs (OR 4.2, 95% CI 2.1 – 8.1) and anxiolytics (OR 2.8, 95% CI 1.5 – 5.3). CONCLUSION: TCAs are commonly used by GIs to treat IBS. However, most GIs prescribed other CN to less than 10% of their IBS patients. Self-assessed competence and comfort levels in prescribing the different classes of CN corresponded with increased use of these medications. Further educational and training efforts should be made to increase the comfort-level of GIs with CN beyond TCAs. Disclosure: W. LeBrett: No Conflicts; B. Nulsen: No Conflicts; D. A. Drossman: Biomerica: Advisory Committees or Review Panels; Salix: Advisory Committees or Review Panels; Shire: Advisory Committees or Review Panels; L. Chang: Allergan: Consulting; Arena Pharmaceuticals: Advisory Committees or Review Panels; IM Health Sciences: Consulting; Ironwood Pharmaceuticals: Advisory Committees or Review Panels; MetaMe: Stock Shareholder; Modify Health: Stock Shareholder; OrphoMed: Advisory Committees or Review Panels; Rome Foundation: Other Activities Not in List ; Salix: Speaking and Teaching; Shire Takeda: Advisory Committees or Review Panels, Speaking and Teaching;
  6. FACTORS AFFECTING CENTRAL NEUROMODULATOR USE BY GASTROENTEROLOGISTS IN THE TREATMENT OF IBS: RESULTS OF A NATIONAL SURVEY Author(s): Benjamin Nulsen1, Wendi LeBrett1, Douglas A. Drossman2, Lin Chang1 INTRODUCTION: Central neuromodulators (CN), including antidepressants and other CNS-targeted medications, are an effective treatment for irritable bowel syndrome (IBS). Little is known about factors that might affect gastroenterologists’ (GIs) prescribing patterns for these medications in their IBS patients. The aims of our study were to measure the use of CN by GIs in the United States (US) to treat IBS, the predictors associated with high vs. low prescribing behavior, and the barriers limiting use. METHODS: A survey consisting of 23 multiple-choice questions was distributed to GIs in the US via email and at local and national GI meetings. Response rates for each question were calculated as raw percentages. We defined those GIs above the median (50.1%; N=208) who prescribed CN to >20% of their IBS patients as “high CN-prescribers.” High CN-prescribers were compared with low CN-prescribers using descriptive statistics and multivariable logistic regression analysis. RESULTS: Among 322 respondents that completed the demographic section of the survey, 65% were male, 58% practiced in the community, and 84% were in practice for ≤30 years. The geographic distribution of respondents was balanced across the US. Overall, 58% (N=171) of GIs described CN as extremely, very or somewhat important in the treatment of IBS, although just 30% (N=89) believed that CN were effective in a majority of their IBS patients. In the multivariable logistic regression analysis, significant predictors of high CN prescribing behavior were working in an academic practice setting (OR 3.53 [95% CI 2.05-6.09]), having a functional GI disorder (FGID)-focused practice (OR 4.08 [2.04-9.15]), higher self-assessed competence at prescribing CN (OR 2.46 [1.33-4.52]), greater importance of using CN (OR 6.30 [2.21-17.96]), and perceived greater effectiveness of CN in treating IBS (OR 3.47 [1.55-7.76]) (Table 1). These associations were confirmed with ordinal regression analysis. The prevalence of psychiatric comorbidity and GIs' comfort using CN to treat psychiatric symptoms did not predict their prescribing behavior of CN in IBS. The most common reasons GIs reported for not prescribing CN were concern about side effects (60%) and uncertainty about choosing the correct medication (33%). Less than 25% of GIs identified beliefs of low efficacy as a barrier to prescribing CN (Figure 2). CONCLUSION Academic and FGID-focused GIs are most likely to prescribe CN and do so to a higher percentage of their IBS patients. Although perceived efficacy is associated with increased use, GIs do not perceive low efficacy as a major barrier to prescribing CN. Efforts to increase GIs’ competence in prescribing CN should focus not only on appropriate medication selection, dose adjustment and side effect management, but also on strategies that providers can use to increase IBS patients’ willingness to take CN. Disclosure: B. Nulsen: No Conflicts; W. LeBrett: No Conflicts; D. A. Drossman: Biomerica: Advisory Committees or Review Panels; Salix: Advisory Committees or Review Panels; Shire: Advisory Committees or Review Panels; L. Chang: Allergan: Consulting; Arena Pharmaceuticals: Advisory Committees or Review Panels; IM Health Sciences: Consulting; Ironwood Pharmaceuticals: Advisory Committees or Review Panels; MetaMe: Stock Shareholder; Modify Health: Stock Shareholder; OrphoMed: Advisory Committees or Review Panels; Rome Foundation: Other Activities Not in List ; Salix: Speaking and Teaching; Shire Takeda: Advisory Committees or Review Panels, Speaking and Teaching;
  7. TREATMENT EXPECTANCY FOR GI SYMPTOM IMPROVEMENT AND MOTIVATION IMPACTS THE QUALITY OF THE THERAPEUTIC ALLIANCE WITH IBS PATIENTS Author(s): Brian M. Quigley1, Christopher Radziwon1, Alison Vargovich1, Jeffrey M. Lackner1 Background: In the absence of a satisfactory medical treatment, the development of the therapeutic alliance between IBS patients and their provider is deemed critical to managing IBS patients (e.g., Drossman, 2006). The therapeutic alliance refers to the quality and nature of the patient–provider relationship, their collaborative interactions, and the emotional bond that emerges during treatment (Bordin, 1979). However, little research has been conducted on what constitutes a sound therapeutic alliance or the factors that influence it. We hypothesized that the therapeutic relationship would be predicted by a hierarchy of factors consisting of more distal sociodemographic variables (e.g., age, race, etc), followed by extraintestinal symptoms (e.g., comorbidities, stress), interpersonal factors (e.g., social support), IBS-specific clinical factors (e.g., GI symptom severity, pain intensity), and finally cognitive variables (e.g., treatment expectancy and motivation) which should be the most proximally related to alliance. Aims: We sought to identify actionable patient-based variables related to therapeutic alliance in patients with refractory IBS. Methods: 436 Rome III-diagnosed IBS patients (80% F, mean age 41 years) completed a battery of clinical measures at pretreatment assessment of an NIH trial comparing the relative efficacy of cognitive behavioral therapy (CBT) relative to a credible nonspecific comparator emphasizing education. Alliance was assessed by patient and clinician-rated measures of the Working Alliance Inventory (WAI; Hatcher & Gillaspy, 2006) at the conclusion of the first treatment session. Alliance was regressed on pretreatment candidate predictor variables which were entered into analyses in blocks beginning with the most distal category of variables, sociodemographic variables, followed by extraintestinal, interpersonal, clinical, and finally cognitive blocks. Variables significant at each step were retained in the subsequent steps. Results: Regression analyses indicated that patient-reported alliance were most strongly and consistently predicted by social support, β = .16 (95% CI = .07/.25), motivation, β = .12 (95% CI = .02/.21), and treatment expectancy, β = .35 (95% CI = .25/.44). Predictors of therapist ratings of alliance were limited to treatment expectancy, β = .16 (95% CI = .05/.26). Conclusions: The most important predictors of alliance are factors that are not fixed and unchangeable but modifiable. Data have clinical implications for improving the quality of care for challenging IBS patients. When managing refractory IBS patients, behavioral strategies that enhance motivation, social support, and treatment expectancy (e.g., motivational interviewing, patient education) may be useful in improving the quality of the therapeutic alliance when medications and dietary treatments fall short. (NIDDK Grant #77738 Disclosure: B. M. Quigley: No Conflicts; C. Radziwon: No Conflicts; A. Vargovich: No Conflicts; J. M. Lackner: No Conflicts;
  8. FACTORS ASSOCIATED WITH EFFICACY OF COGNITIVE BEHAVIOR THERAPY VS EDUCATION FOR PATIENTS WITH IRRITABLE BOWEL SYNDROME Author(s): Jeffrey M. Lackner1, James Jaccard2, Rebecca S. Firth1, Susan S. Krasner1, Frank A. Hamilton3, Laurie Keefer4, Chang-Xing Ma1, Christopher Radziwon1, Michael D. Sitrin1, Darren M. Brenner4, Gregory D. Gudleski1, Leonard A. Katz1 Background & Aims: Among patients with irritable bowel syndrome (IBS), it would be helpful to identify those most likely to respond to specific treatments, yet few factors have been identified that reliably predict positive outcome. We sought to identify pretreatment baseline characteristics that associate with gastrointestinal symptom improvement in patients who received empirically validated regimens of cognitive behavior therapy (CBT) or IBS education. Methods: We analyzed data from the IBS Outcome Study, in which 436 patients with IBS (average age, 41 years; 80%, female) were randomly assigned to groups that received 4 or 10 sessions of cognitive behavior therapy or education over 10 weeks. Baseline data were collected from all participants on sociodemographic and clinical features and comorbidities. Interaction analyses used a modified linear probability model with Huber-White robust estimators to identify baseline factors that moderated as a function of treatment condition GI symptom improvement based on the IBS-version of the Clinical Global Impressions-Improvement Scale. Results: Whether the primary outcome of IBS symptom improvement was rated by patients or physician assessors blind to treatment 2 weeks after it ended, higher percentages of patients had symptom improvement after CBT compared with EDU among those with low levels of trait anxiety (71.3% vs 34.9%; P < .05) or anxiety sensitivity (71.7% vs 38.6%; P < .05) and for those with baseline typical levels of trait anxiety (66.0% vs 47.1%; P < .05) or anxiety sensitivity (66.3% vs 47.1%; P < .05). For patients with high trait anxiety or anxiety sensitivity, the difference in percentage of responders to CBT vs EDU was non-significant for trait anxiety (60.6% vs 59.2%) and anxiety sensitivity (60.9% vs 55.9%). If patients scored at or below 22 on the Trait Anxiety Inventory, CBT had a statistically significant advantage over EDU. If patients scored at or below 29 on the Anxiety Sensitivity Inventory, there was a statistically significant advantage for CBT vs EDU. Conclusions: In analyses of outcomes of patients with treatment-refractory IBS, baseline levels of trait anxiety and anxiety sensitivity (fear of arousal symptoms) were associated with improved gastrointestinal symptoms following CBT compared to IBS education. These findings and approaches might be used to optimize selection of treatment for patients with IBS Disclosure: J. M. Lackner: No Conflicts; J. Jaccard: No Conflicts; R. S. Firth: No Conflicts; S. S. Krasner: No Conflicts; F. A. Hamilton: No Conflicts; L. Keefer: Abbvie: Grant/Research Support; Lucid Technologies: Consulting; Metame Health: Stock Shareholder; Pfizer: Grant/Research Support, Advisory Committees or Review Panels; Rome Foundation: Board Membership; Takeda/Shire: Speaking and Teaching; C. Ma: No Conflicts; C. Radziwon: No Conflicts; M. D. Sitrin: No Conflicts; D. M. Brenner: Allergan: Speaking and Teaching; Alnylam: Advisory Committees or Review Panels; AlphaSigma: Board Membership; GI Health Foundation: Consulting; Ironwood: Speaking and Teaching; Salix: Speaking and Teaching; Takeda/Shire: Speaking and Teaching; G. D. Gudleski: No Conflicts; L. A. Katz: No Conflicts;
  9. DO I REALLY HAVE TO DO MY HOMEWORK?: THE RELATIONSHIP BETWEEN HOMEWORK COMPLIANCE AND GI SYMPTOM IMPROVEMENT FOLLOWING COGNITIVE BEHAVIORAL THERAPY (CBT) FOR IRRITIBLE BOWEL SYNDROME Author(s): Sarah Mason1, Christopher Radziwon1, Brian M. Quigley1, Gregory D. Gudleski1, Alison Vargovich1, Ashlye Borden1, Jeffrey M. Lackner1 Background: In the absence of a medical cure, treatment guidelines for irritable bowel syndrome (IBS) emphasize behavioral self-management that is designed to teach patients a set of skills for controlling and/or reducing refractory GI symptoms (e.g., NICE, 2017, Ford et al., NEJM, 2017). An important mechanism for improving self-control of IBS (and other chronic diseases) is extrasession home practice. In the case of cognitive-behavioral therapy (CBT), home exercises are designed to rehearse new skills so that they generalize to natural environments where GI symptoms are most likely to occur. Whether the completion of GI homework facilitates symptom improvement is, however, uncertain. Aims: To examine whether homework compliance is related to clinically significant treatment response and treatment satisfaction. Methods: Subjects included 436 Rome III-diagnosed IBS patients (80% F, M age 41 years) who participated in an NIH trial comparing the relative efficacy of clinic-based (or standard) CBT, home-based CBT, and a non-specific comparator featuring IBS education. Homework completion was rated by the clinician using a 6-item scale (0 =0%, 1 = 1-25%, 2 = 26-50%, 3 = 51-75%, 4 = 76-100%, 5 = completed more than assigned) assessed at the end of sessions during weeks 3, 5, 7, and 8 of a 10-week acute treatment phase. Outcome was measured with the Clinical Global Impressions Scale (CGI) during treatment (week 5), and at 2 weeks, 3 months and 6 months post-treatment. Treatment satisfaction was measured with the 8-item Client Satisfaction Questionnaire. Results: There was no significant relationship between homework compliance in the first 5 weeks of treatment and positive treatment response at the 5th week of treatment, OR = 1.01, 95% CI = 0.99/1.02, p =.066. Standard CBT patients completed less homework than patients in other conditions at week 5 and those who did not show response by week 5 were least homework compliant over the course of the study, F(6,1080) = 2.59, p = .008. Homework completion rate over the course of treatment corresponded with greater improvement at 2-week post treatment, β = .19, t = 3.48, p =.001, as well as at the 3-month, β = .18, t = 3.24, p =.001, and the 6-month follow-ups, β = .16, t= 2.63, p =.009. Additionally, when controlling for treatment improvement (CGI), homework completion rate was a significant predictor of treatment satisfaction at the 2-week follow up, β = .12, t = 2.67, p =.008. Conclusions: Treatment homework compliance had no significant impact on the rapidity of treatment response. However, homework completion over the entire course of treatment significantly predicts global improvement of GI symptoms at short- and longer term follow-ups and also predicts treatment satisfaction. Findings suggest that completion of homework assignments is an important mediator of response to CBT. (NIDDK Grant #77738 Disclosure: S. Mason: No Conflicts; C. Radziwon: No Conflicts; B. M. Quigley: No Conflicts; G. D. Gudleski: No Conflicts; A. Vargovich: No Conflicts; A. Borden: No Conflicts; J. M, Lackner: No Conflicts;
  10. NUTRITIONAL IMPLICATIONS RELATED TO FOLLOWING A LOW FODMAP DIET IN CHILDREN WITH IBS Author(s): Ann R. McMeans1, Rebecca B. Cappello1, Kristi L. King1, Zoe Carbo1, Gabrielle Kane1, Margaret Heitkemper2, Rona L. Levy2, Robert J. Shulman1, Bruno P. Chumpitazi1 Background: A low fermentable oligosaccharide disaccharide monosaccharide and polyol (FODMAP) diet may ameliorate irritable bowel syndrome (IBS) symptoms. Though the low FODMAP diet is focused on restricting fermentable carbohydrates, whether it affects intake of calories, macronutrients, micronutrients, and whether it affects diet quality is unknown. Objective: To determine the nutritional impact of following a low FODMAP diet in children with IBS. Methods: Children with IBS (ages 7-17 years) are being actively enrolled in an ongoing randomized parallel group intervention trial. One arm of the intervention trial is a low FODMAP diet intervention based on registered dietitian education and educational materials. Participants completed a 3 day food record at baseline and two weeks into the low FODMAP diet. Macronutrient and micronutrient content from the food records was analyzed using the ESHA Food Processor Nutrient Analysis Program. Diet quality was assessed by the number of meals (e.g., breakfast, lunch, dinner), and snacks consumed. MyPlate was used to assess nutrient quality by determining the percentage of recommended intake of grains, vegetables, fruit, dairy, and protein. P-values <0.05 were considered significant. Results: To date, 15 children with IBS have completed a baseline (prior to low FODMAP education) and second (after second low FODMAP education) food record to date. In comparison to baseline diet consumption, participants had a decrease in daily kilocalorie and carbohydrate consumption (Table). There were a small number of micronutrient consumption differences when comparing baseline vs. low FODMAP diet intake (Table). While on the low FODMAP diet, children with IBS increased the number of standard meals over 3 days from 7.1 ± 1.2 to 8.1 ± 1.2 meals (P<0.05) without a significant change in the number of consumed snacks. When comparing baseline vs. low FODMAP diet intake there was no significant change in the % intake of recommended grains, vegetables, dairy, or proteins. However, there was an increase in the percentage of recommended fruit consumption from 16.5 ± 17.4% to 37.5 ± 34.3% (P=0.019). Conclusions: In children with IBS, following a low FODMAP diet resulted in a decrease in kilocalories and carbohydrates consumed. There were a small number of micronutrient consumption changes. Overall diet quality improved in participants while on a low FODMAP diet with an increased number of standard meals and consumption of fruits. Disclosure: A. R. McMeans: No Conflicts; R. B. Cappello: No Conflicts; K. L. King: Abbott Nutrition: Speaking and Teaching; Nutricia: Speaking and Teaching; Z. Carbo: No Conflicts; G. Kane: No Conflicts; M. Heitkemper: No Conflicts; R. L. Levy: No Conflicts; R. J. Shulman: Rome Foundation: Other Activities Not in List ; B. P. Chumpitazi: Rome Foundation: Other Activities Not in List ;
  11. UTILITY OF A CONSUMER-FRIENDLY PORTABLE HYDROGEN BREATH ANALYSER DEVICE FOR MONITORING COLONIC FERMENTATION AND SENSATION IN RESPONSE TO SUPPLEMENTAL FIBER Author(s): Claire Shortt1, Niall McGovern1, Eoghan Lafferty1, Pankaj J. Pasricha2 BACKGROUND: Fermentation of soluble fibers by fecal microbiota is vital for colonic health and leads to production of hydrogen (H2) and other volatiles. On the other hand, excessive or aberrant fermentation is associated with gastrointestinal distress. There are currently no practical methods for monitoring fermentation in the gut. To address this need, we developed a handheld breathalyzer device linked to a smartphone (AIRE, FoodMarble, Dublin, Ireland) and validated its utility to measure breath H2 and associated symptoms in response to supplemental fiber. METHOD: We studied 20 subjects (15 healthy, 5 IBS) in a double-blind, randomized, crossover design (1-week baseline, 2-weeks 1st fiber, 2-week wash-out, 2-weeks 2nd fiber, 1-week washout) using 2 different prebiotics a galacto-oligosaccharide (GOS) and a wheat dextrin (WD) fiber. 6-9 breath measurements were made daily along with scoring bloating, flatulence and abdominal pain, on a 0-10 scale. Data was analysed using 2-way ANOVA and Pearson’s correlation and linear regression as appropriate. RESULTS: Interim results show that for the group as a whole, both prebiotic fibers produced a highly significant change in breath H2 compared to baseline, for both week 1 and 2 (Figure 1). After discontinuation of the prebiotic, H2 values returned to baseline. There were no statistically significant differences between the H2 levels in weeks 1 and 2 for the two prebiotics. However, there was large inter-subject variability in the individual responses. We next examined patient-reported sensation which was mild and comparable in both groups, with no overall change in either prebiotic group, compared to baseline period (GOS versus WD; “pain”= 0.7 vs. 0.65; bloating = 1.45 vs. 1.41; flatulence = 1.27 vs. 1.07, P=NS for all). Nevertheless, there were significant correlations between breath H2 and “pain” (r=0.18; P=0.02), bloating (r=0.31; p <0.0001) and flatulence (r=0.49; p <0.0001). CONCLUSION: This study demonstrates the ability of a portable device/app to continually monitor breath H2 levels along with subjective symptoms, detecting the expected increase in colonic fermentation by supplemental fiber before returning to baseline after discontinuation. Results of fecal microbial analysis are awaited but the preliminary results suggest that the device may enable the consumer to monitor the activity of their own microbiota in response to fiber or fermentable foods (such as FODMAPs) and potentially titrate the quantity in an objective, quantifiable and personalized manner. The correlation analysis also suggests that colonic fermentation can be sensed by consumers, even at subclinical levels. While further studies are needed, this device may enable more accurate detection of symptoms in a number of patient populations including IBS and small intestinal bacterial overgrowth. Disclosure: C. Shortt: FoodMarble: Employment; N. McGovern: FoodMarble: Employment; E. Lafferty: FoodMarble: Employment; P. J. Pasricha: Apollo Endosurgery: Stock Shareholder; Auris: Consulting; Bluefield: Grant/Research Support; Boston Pharma: Grant/Research Support; Censa: Patent Held/Filed; Ciitizen: Stock Shareholder; D&D Pharma: Stock Shareholder; Food Marble: Consulting; GI Scientific: Consulting; GI Supply: Consulting; Glyscend: Patent Held/Filed; GSK consumer: Independent Contractor; Ihibikase: Consulting; Neurogastrx: Stock Shareholder; Orphomed: Advisory Committees or Review Panels; Ovibio: Advisory Committees or Review Panels; P4Microbiome: Stock Shareholder; Pendulum: Consulting; Pentax: Consulting; Teva: Grant/Research Support; Theraly: Patent Held/Filed; Vanda: Consulting; Y-Trap: Consulting;
  12. PREDICTING TREATMENT RESPONSE TO THE LOW FODMAP DIET IN IBS: THE ROLE OF ILLNESS PERCEPTIONS Author(s): Lauren Manning1, Jessica Biesiekierski1, Lukas Van Oudenhove2,3 Background The low fermentable oligosaccharide, disaccharide, monosaccharide and polyol (FODMAP) diet has shown efficacy in irritable bowel syndrome (IBS) at the group level, but not all patients respond to the treatment. Predictors of treatment response at the individual subject level are lacking. We aimed to investigate baseline illness perceptions as predictors of treatment response and their cross-sectional associations with baseline IBS symptom levels. Methods Adults (>18 years) with IBS symptoms were recruited from dietetic practice clinics and via social media. Participants completed questionnaires at 3 timepoints corresponding with low FODMAP diet intervention; pre-dietitian appointment, immediately post and 4 weeks post initial consult. Figure 1 shows the timeline of data collection and dietitian contact. An interim analysis of illness perceptions was measured using the Illness Perceptions Questionnaire which includes 8 subscales: identity, timeline, consequences, personal control, treatment control, illness coherence, timeline cyclical and emotional representations. The outcome measure, the IBS symptom severity score (IBS-SSS) was treated as a continuous variable in a linear mixed model including the main effect of the baseline illness perception variable, the main effect of time and their interaction effect (testing the hypothesis that the baseline variable predicts response slope). Results 35 participants (85% F) aged 35±13.3 years were included. In a model without covariates, the low FODMAP diet was shown to be effective at the group level, reflected by a significant negative slope of time (β=-10.73±2.27, p<0.0001) indicating a decrease with on average 10.7 points on the IBS-SSS per week treatment. The identity (β=33.1±10.2, p=0.003), time (β=29.6±10.0, p=0.006), consequences (β=36.8±9.4, p<0.001), and emotional representations (β=25.1±10.7, p=0.025) subscales at baseline were significantly associated with higher baseline levels of IBS symptoms, whereas the treatment control subscale was associated with lower baseline symptom levels (β=-27.9±10.5, p=0.012). None of these baseline variables were associated with treatment response (interaction effects all p>0.15). Higher personal control and illness coherence cognitions were not associated with differences in baseline levels of IBS symptoms (both p>0.10), but at trend level with a stronger treatment response (β=-3.84±2.23, p=0.094 and β=-4.19±2.20, p=0.065). No significant associations were found for the timeline cyclical subscale. Conclusion Different illness perceptions are associated with either baseline levels of IBS symptoms or with treatment response to the low FODMAP diet. If trends in this interim analysis are confirmed in the full sample, improving understanding of the illness and cognitions on personal control of symptoms before treatment may boost efficacy of the low FODMAP diet Disclosure: L. Manning: No Conflicts; J. Biesiekierski: No Conflicts; L. Van Oudenhove: Danone: Consulting; Nestlé: Grant/Research Support;
  13. HYPERACTIVITY AND AGGRESSION ARE ASSOCIATED WITH AUTONOMIC NERVOUS SYSTEM DYSFUNCTION IN CHILDREN WITH FUNCTIONAL ABDOMINAL PAIN DISORDERS Author(s): Miranda A. van Tilburg3, Robert Burr2, Margaret Heitkemper2, Joan M. Romano2, Robert J. Shulman1, Rona L. Levy2 BACKGROUND: Functional Abdominal Pain Disorders (FAPDs) are posited to be caused by brain-gut dysfunction, such as altered responses to stress through hyperarousal of the autonomic nervous system. The aim of this study was to examine if autonomic nervous system function is associated with psychological symptoms in children with FAPDs. METHODS: Secondary data analysis of data collected from 37 children (Mean age 10.1±1.6; 64.9% female; 56.8% black, 35.1% white, 27.1% Hispanic), with a physician diagnosis of FAPDs, participating in a randomized clinical trial of Cognitive Behavioral Therapy versus a low FODMAP diet. Data collection is ongoing and the numbers here represent an intermediate analysis. Baseline (pre-treatment) data were collected on Internalizing (anxiety, depression, somatization) and externalizing (hyperactivity, aggression) symptoms as measured by the Behavior Assessment System for Children completed by parents. In addition, heart rate variability was collected during a 20-minute period in the afternoon with the child supine and at rest. Measures include both low (LF) and high (HF) frequency power, reflecting parasympathetic control, as well as log linear LF/HF ratio (a measure of sympathovagal balance). RESULTS: Spearman correlations yielded significant associations between Externalizing symptoms and HF (ρ = -0.38; p = 0.028), LF (ρ = 0.38; p = 0.029), and LF/HF ratio (ρ = 0.39; p = 0.024). No significant associations were found between Internalizing symptoms and any heart rate variability measures (spearman correlations varied from -0.19 to 0.20). CONCLUSION: Higher HF and lower LF were associated with more Externalizing symptoms in children with FAPDs. This heart rate variability pattern is indicative of low parasympathetic activity and has been associated with greater perceived stress. In most studies, Internalizing symptoms have been found to predict negative outcomes in children with FAPDs. Few studies to date have examined the role of Externalizing symptoms. The current findings indicate that Externalizing symptoms could be an important target for treatment in children with FAPDs. Larger studies are needed to confirm these results, but if replicated, these findings could support the use of interventions to reduce hyperarousal, such as relaxation, in children with FAPDs who exhibit Externalizing symptoms. This study is supported by R01 NR01678 Disclosure: M. A. van Tilburg: Mahana Therapeutics: Consulting; R. Burr: No Conflicts; M. Heitkemper: No Conflicts; J. M. Romano: No Conflicts; R. J. Shulman: Rome Foundation: Other Activities Not in List ; R. L. Levy: No Conflicts;
  14. FREQUENCY AND INTENSITY OF GASTROINTESTINAL SYMPTOMS RELATED TO FERMENTABLE CARBOHYDRATES IN SUBJECTS SELF- REPORTED MILK INTOLERANT Author(s): Sophia E. Martinez Vazquez1, Jose M. Remes Troche2, Jose R. Nogueira3, Ramon Carmona Sanchez8, María E. Icaza Chávez4, Maria V. Bielsa5, Alejandra Noble-Lugo6, Ricardo Raña-Garibay6, Guillermo R. Aceves-Tavares7, Enrique Coss-Adame1, Luis Uscanga1 Background: Many patients with chronic gastrointestinal disorders relate their symptoms with foods containing milk and dairy products and they avoid them without any test confirming lactose maldigestion or intolerance to other milk components. Objective: Analyze the frequency and the intensity of gastrointestinal symptoms related to highly fermentable sugars in patients with self- reported milk and dairy products intolerance. Material and methods: A cross- sectional survey convened through an electronic platform with convenience non probabilistic sampling in adult patients with chronic gastrointestinal disorders. They answered a previous validated questionnaire exploring lactose intolerance with 7 items including other FODMAP (fermentable oligo-di-mono saccharides and poliols), intensity (VAS) and frequency (# day in a week) of abdominal distention and pain, gas production, bowel movements, nausea, urgency to evacuate, diarrhea and chest burning. We excluded those who did not complete the questionnaire. Patients were divided in two groups: 1. Milk intolerant (MI) and 2. Milk tolerant (MT). All of them signed an informed consent. A descriptive analysis using frequencies, and once the patients were divided by their self- identification of MI, hypothesis test with t- Student and U Mann- Whitney, Spearman correlation, principal component analysis (p≤ 0.05) and a logistic regression were performed to confirm the findings. Results: Of 830 respondents, 464 (56%) self- reported as milk intolerants, and of them 481 (58%) had eliminated the milk of their habitual diet. The average age was 42 years old, the majority were female (around 70%). The weekly frequency of symptoms was twofold greater in the MI group (p= 0.000) as well as the intensity of symptoms was almost quadruple (p= 0.000). A principal component analysis showed and arrange that explained the 51% of variance for the frequency construct including: abdominal distention and pain, gases production, intestinal movements and urgency to evacuate (r> 0.726); meanwhile the arrange for intensity of symptoms, that explained 46% of variance, was abdominal distention and pain, diarrhea and urgency to evacuate (r> 0.702). Both models were confirmed with a logistic regression showed that abdominal distention and pain, diarrhea and urgency to evacuate were associated with dairy products in the MI group (p< 0.05) and any fermentable sugars were associated with gases production and bowel movement. Conclusion: The frequency and intensity of gastrointestinal symptoms such as abdominal distention and pain, diarrhea and urgency to evacuate, are major among chronic gastrointestinal patients with self- reported of milk and dairy intolerants. This is the first study that shows a symptoms pattern in this kind of patients in México Disclosure: S. E. Martinez Vazquez: No Conflicts; J. M. Remes Troche: Asofarma: Advisory Committees or Review Panels; Johnson and Johnson: Speaking and Teaching; Medtronic: Speaking and Teaching; Sanfer: Grant/Research Support; Takeda: Advisory Committees or Review Panels, Speaking and Teaching; J. R. Nogueira: No Conflicts; R. Carmona Sanchez: No Conflicts; M. E. Icaza Chávez: No Conflicts; M. V. Bielsa: No Conflicts; A. Noble-Lugo: Asofarma: Speaking and Teaching; Takeda: Speaking and Teaching; R. Raña-Garibay: AlfaSigma: Speaking and Teaching; Menarini: Speaking and Teaching; G. R. Aceves-Tavares: No Conflicts; E. Coss-Adame: No Conflicts; L. Uscanga: No Conflicts;
  15. SLEEP PARASOMNIAS ARE ASSOCIATED WITH AUTONOMIC NERVOUS SYSTEM DYSFUNCTION IN CHILDREN WITH FUNCTIONAL ABDOMINAL PAIN DISORDERS Author(s): Miranda A. van Tilburg2, Robert Burr3, Jennifer Cowie-Jansen1, Mariella M. Self1, Margaret Heitkemper3, Joan M. Romano3, Rona L. Levy3, Robert J. Shulman1 BACKGROUND: Disturbed sleep has been found in children with Functional Abdominal Pain Disorders (FAPDs). Physiological hyperarousal of the autonomic nervous system (ANS) during sleep may contribute to both disturbed sleep as well as pain. The aim of the current ongoing pilot study was to examine if altered ANS functioning was associated with disturbed sleep in children with FAPDs. METHODS: Secondary data analysis of data collected from 37 children with a physician diagnosis of FAPDs who are participating in a randomized clinical trial of Cognitive Behavioral Therapy versus low-FODMAP diet. Recruitment is ongoing and more data will be available in the next months. At baseline, parents completed the Children's Sleep Habits Questionnaire. Heart rate variability was collected during a 20-minute period in the afternoon while the child was supine and at rest. Measures include both low (LF) and high (HF) frequency power, reflecting parasympathetic control, as well as log linear LF/HF ratio (a measure of sympathovagal balance). RESULTS: Mean child age was 10.1±1.6; 64.9% female; 56.8% black, 35.1% white, and 27% Hispanic. Spearman correlations yielded significant associations between parasomnias (e.g., sleep walking, night terrors, bruxism, etc.) and LF (ρ =-0.47; p = 0.003; see Figure 1) as well as HF power (ρ =-0.42; p = 0.009; see Figure 2). Correlations between other sleep variables (sleep anxiety, night awakenings, sleep disordered breathing) and HF as well as LF/HF ratio were low and non-significant (Spearman correlations ranged from -0.21 to 0.25). CONCLUSION: Decreased LF and HF, indications of changes in (para)sympathetic nervous system activity, were associated with more parasomnias in children with FAPDs. Larger studies are needed to confirm these results and determine whether autonomic nervous system dysfunction may be a link between sleep disturbances and pain in FAPDs. This study is supported by R01 NR016786 Disclosure: M. A. van Tilburg: Mahana Therapeutics: Consulting; R. Burr: No Conflicts; J. Cowie-Jansen: No Conflicts; M. M. Self: No Conflicts; M. Heitkemper: No Conflicts; J. M. Romano: No Conflicts; R. L. Levy: No Conflicts; R. J. Shulman: Rome Foundation: Other Activities Not in List ;
  16. IMPACT OF PARENTAL ILLNESS AND INJURY ON PEDIATRIC DISORDERS OF GUT-BRAIN INTERACTION Background: Disorders of gut-brain interaction (DGBI) have been associated with psychosocial stressors in children. Parental injuries and illnesses (PII) are known stressors which impact children’s health. We hypothesized that PII would be associated with increased healthcare and prescription use for DGBIs.Methods: A self-controlled case-control study using Military Health System Data evaluated the rate of DGBI visits and odds of prescription use before and after a PII. Children ages 3-16 with a military parent ill or injured 2004-14 were included. Those with diagnosed systemic or organic gastrointestinal disease were excluded. International Classification of Diseases 9 codes identified outpatient visits for irritable bowel syndrome (IBS), abdominal pain, constipation, and fecal incontinence (FI) in the 2 years before and after parental injury. Laxatives and antispasmodics were identified by name in outpatient pharmacy records for the same periods. Visit rates before and after PII were compared for each diagnosis and a DGBI composite using negative binomial regression analysis; logistic regression compared the number of children on each medication before and after injury. Analyses controlled for ADHD, ODD, anxiety, depression, and obesity. Stratified analyses examined the impact of child age. Secondary analysis compared post injury visit rates and prescriptions of children of brain injured parents (PTSD/TBI) to children of physically injured parents.Results: A total of 442,651 children were included. For children of all ages visits for DGBIs increased 5% (IRR=1.05; 95% CI [1.03-1.07]) following a PII; visits for abdominal pain and IBS increased 7% and 37% respectively. Visits for constipation and FI did not significantly change with PII (Table 1). Odds of being prescribed an antispasmodic increased 24% following PII, and odds of being prescribed a laxative decreased 8%. Children <6 had increased care for constipation (9%), FI (129%), abdominal pain (40%) and all DGBIs (25%). Children 6-12 had increased IBS care (34%) and antispasmodic prescription (13%). Children >12 had increased odds of laxative prescription (13%), antispasmodics (39%), and increased IBS (51%), pain (6%) and all DGBIs (5%) care. Compared to children of physically injured parents, children of brain injured parents had more post injury visits for abdominal pain (5%) and increased odds of antispasmodic prescription (24%). Visits for other care types, and odds of laxative prescription did not differ by parental injury type (Table 2).Conclusion: PII is associated with increased healthcare utilization for pain related DGBIs, and increased antispasmodic prescription. Parental brain injury has the highest association with increased abdominal pain and antispasmodics prescription. PII is associated with defecation related DGBIs, only in children under 6. Disclosure: P. Short: No Conflicts; C. Sullivan: No Conflicts; A. Susi: No Conflicts; E. Hisle-Gorman: No Conflicts;
  17. GUT DYSBIOSIS INDUCED BY CIRCADIAN RHYTHM DISRUPTION PROMOTES VISCERAL HYPERSENSITIVITY: MEDIATION BY DEGRADATION OF COLONIC MUCUS BARRIER AND LPS ENDOTOXEMIA Author(s): Xiaomin Hu1, Shi-Yi Zhou1, Yawen Zhang1, Weiyang Zheng1, Merritt Gillilland1, Chung Owyang1 Clinical studies suggest that time-shift workers have increased incidence of IBS. We and others have shown that circadian rhythm disruption is associated with gut dydbiosis. We hypothesize that circadian rhythm disruption modulates visceral hypersensitivity (VH) by promoting the growth of mucolytic bacteria resulting in increased gut permeability and mucosa inflammation. To test this hypothesis, mice were exposed to an 8 hr time shift every 3 days for 8 wk. 16s rRNA sequencing of fecal samples showed circadian rhythm disruption caused an increase in Prevotellaceae (from 0.004% to 14 %) and Ruminococcus (from 1.4 % to 4.3 %). Both bacteria are foragers of host-derived mucins. In addition, there was an increase in abundance of Bacteroidetes (Gm-ve) and a reduction in Firmicutes (Gm+ve). Prediction of metagenomic functional contents using PICRUSt showed differential enrichment of carbohydrate digestion pathways (3.8- fold), glycan biosynthesis and metabolism pathways (1.5-fold) as well as an increase in lipopolysaccharide biosynthesis (1.3-fold) and bacterial motility proteins metabolism (1.2-fold). These changes were associated with a 60% decrease in the thickness of colonic mucus layer (P<0.01), a 50% reduction in bacterial-epithelial distance (P<0.05) and > 20-fold increase in epithelial DUOX maturation factor 2 (DUOXA2) indicating enhanced bacterial attachment to the epithelium. Mucosal changes include increased expression of TNFα (2.5-fold), IL1β (3.4-fold), IL12 p40 (2.7-fold), IL17 (2.3-fold) and IFNG (3.5-fold). These were accompanied by 35% decrease in epithelial junction protein ZO1 and 40% reduction in TEER indicating impairment of mucosal barrier function. The Gm-ve gut dysbiosis resulted in a 20% increase in circulating LPS (P<0.05). Pain behavior showed that disruption of the circadian rhythm caused a 3-4-fold increase in visceromotor response (VMR) to colorectal distention (CRD) compared to controls. To confirm circadian rhythm disruption-induced gut dysbiosis contributes to enhanced nociception in the gut, we performed fecal transplant studies using germ free mice conventionalized with mice subjected to circadian rhythm disruption. Pain behavior studies performed 4 wk after conventionalization showed a 2-fold increase in VMR to CRD compared to mice conventionalized with control mice. Similar observations in pain perception were made in mice receiving fecal samples from 4 human transpacific travelers who experienced 12-hr time shifts. These nociception abnormalities were not observed 2 wk after transpacific travel. In conclusion, circadian rhythm disruption alters gut microbiota leading to microbial degradation of colonic mucus barrier and disruption of intestinal homeostasis. These changes in conjunction with increased circulating LPS level causes VH and may explain the increased incidence of IBS in time-shift workers Disclosure: X. Hu: No Conflicts; S. Zhou: No Conflicts; Y. Zhang: No Conflicts; W. Zheng: No Conflicts; M. Gilliland: No Conflicts; C. Owyang: No Conflicts;
  18. EFFECTS OF SHORT-TERM PPI INTAKE ON PRODUCING SIBO AND BOWEL SYMPTOMS. A STUDY IN HEALTHY VOLUNTEERS Author(s): Cristina Durán Rosas1, Bryan A. Priego Parra1, Lydia A. Mercado2, Eliana C. Morel Cerda1, Carlos Arturo Aquino-Ruiz1, Arturo Triana-Romero1, Mercedes Amieva-Balmori1, Federico B. Roesch Dietlen1, Jose Antonio Velarde Ruiz Velasco2, Jose M. Remes Troche1 Background: Currently, proton pump inhibitors (PPIs) are one of the most commonly prescribed drugs in the primary care setting and have great benefit for patients with acid related disease. Although PPIs are generally well tolerated, accumulating evidence suggests that PPIs have long-term risks such as dysbiosis inducing small intestinal bacterial overgrowth (SIBO). However, while several studies have demonstrated a relationship between the development of SIBO and intake of PPIs, other studies have published conflicting result. Furthermore, the short-term effect of PPI use on producing SIBO is unknown. Aim: To evaluate the incidence of SIBO and bowel symptoms after 7 days of PPI intake in a group of healthy controls. Material and methods: 31 healthy subjects (70% female, mean age 28 years) according to GERD-Q and PAGI-SYM questionnaires were included. Subjects received pantoprazole 40 mg once a day, 15-30 minutes before breakfast for 7 days. Before starting therapy and at 7 days each patient completed a symptom evaluation including bloating, abdominal pain, flatulence and diarrhea. Also, Bristol form stool scale (BFSS) was recorded before and after treatment. Glucose hydrogen breath test (GHBT) was carried out prior to and 7 days after therapy in each subject using the criteria proposed by the North America consensus (75 gms. of glucose and positive for SIBO if a raise of ≥ 20 ppm from baseline in hydrogen by 90 min). The study was performed in accordance with the Institutional Ethics Committee of our University, and a written informed consent was obtained. The incidence of SIBO and symptoms after 7 days were reported. Results: Among 31 subjects, one was excluded because had a positive GHBT before treatment. Overall mean basal hydrogen levels before PPI consumption was 5.3 ± 2.3 and after treatment was. 5.8± 2.3. The incidence of SIBO after 7 days of PPI administration was 10% (3/10, CI 95% 3-24%). In these subjects, mean basal hydrogen levels before PPI consumption was 6 ± 1 and after treatment was 10 ± 7. Rise of hydrogen levels occurs at 30,45 and 60 minutes respectively. In all three cases, bowel symptoms appear after PPI treatment: 3 report bloating, 2 flatulence and 1 diarrhea. Mean BFSS changed from 2.6 ± 1.1 at baseline to 4 ± 1 (p=0.10) Among the subjects that did not develop SIBO (n=27) the presence of intestinal symptoms after PPI intake was present in 3 (11%) of them: 2 had bloating and one flatulence Conclusions: This study shows for first time that a 7-day course of PPI cause SIBO in 10% of healthy subjects. These results confirm the hypothesis that profound gastric acid suppression induce dysbiosis predisposing to bacterial overgrowth and potentially enteral infections. Our findings highlight the need for careful and judicious prescription of PPIs Disclosure: C. Durán Rosas: No Conflicts; B. A. Priego Parra: No Conflicts; L. A. Mercado: No Conflicts; E. C. Morel Cerda: No Conflicts; C. Aquino-Ruiz: No Conflicts; A. Triana-Romero: No Conflicts; M. Amieva-Balmori: No Conflicts; F. B. Roesch Dietlen: No Conflicts; J. Velarde Ruiz Velasco: Takeda Mexico: Speaking and Teaching; J. M. Remes Troche: Asofarma: Advisory Committees or Review Panels; Johnson and Johnson: Speaking and Teaching; Medtronic: Speaking and Teaching; Sanfer: Grant/Research Support; Takeda: Advisory Committees or Review Panels, Speaking and Teaching;
  19. PILOT STUDY TO DETERMINE FERMENTABILITY AND TOLERABILITY OF ARTIFICIAL SWEETENERS IN HEALTHY CONTROLS AND IRRITABLE BOWEL SYNDROME PATIENTS Author(s): Amit Gupta1, Jason Baker1, Jeremy Farida1, Emily Haller1, Lydia Watts1, Moira Armstrong1, Gabrielle Ezell1, William D. Chey1 Background: Sugar substitutes (SS) are a popular means of reducing caloric intake. Two popular SS are sucralose/maltodextrin (Splenda) and stevia extract/dextrose (Stevia in the Raw). SS have been touted as non-fermentable by humans, and thus, devoid of gastrointestinal (GI) symptoms though little data support these claims. Aims: (i) Determine whether SS (sucralose [SUC] and stevia [STE]) are fermentable by humans. (ii) Determine if SUC and STE lead to differences in fermentation or GI symptoms in healthy controls (HC) and irritable bowel syndrome (IBS) patients. (iii) Determine if fermentation of SUC and STE correlate with GI symptoms reported during testing. Methods: Prospective pilot study from a tertiary-care center in HC and IBS (Rome IV) subjects. Hydrogen breath test (HBT) preparation included a two-day low FODMAP diet and nothing to eat or smoke for 8 hours prior to HBT. Each subject consumed 50% of the maximum Acceptable Daily Intake (ADI) of either SUC or STE as defined by the US FDA and Joint FAO/WHO Expert Committee on Food Additives (SP = Wt in Kg x 0.38 x 0.5 and SIR = Wt in Kg x 0.15 x 0.5). HBT consisted of a baseline breath sample, consumption of the SS, and subsequent breath samples and symptom assessment q15 minutes for 6 hours. Breath samples were analyzed for H2 (ppm) and CH4 (ppm) (Quintron Breathtracker SC, Milwaukee, WI). Subjects with a baseline breath H2 or CH4 excretion of ≥ 5 ppm were excluded. A ≥10 ppm rise from baseline in H2 and/or ≥3 ppm in CH4 identified fermentation. Abdominal pain, bloating, gas, diarrhea, urgency, fatigue, and nausea were recorded with each breath sample. Bivariate and Pearson correlation analysis was performed. A p-value of ≤0.05 was considered statistically significant. Results: 16 subjects (HC = 9, IBS = 7) underwent SS HBT. Subject characteristics included mean age 38.1 ± 14.9, 54.5% female, 86.4% Caucasian, and mean BMI 27.0 ± 8.4. Demographics were similar between groups, except BMI which was higher in IBS vs. HC (34.2 vs. 22.9 p =0.02). Overall, SS were fermented by 36.4% of subjects with similar rates of fermentation of SUC and STE (30% and 41.7%). There was no significant difference in fermentation rate in IBS vs. HC. Despite this, GI symptoms were more common in the IBS group (SUC bloating p=0.03, STE bloating p=0.03, and STE diarrhea p=0.03) (Table 1). Fermentation of SS correlated with bloating (r=0.17). Conclusion: Sucralose and stevia are fermented by some humans. Fermentation is associated with GI symptoms, particularly in IBS patients. This suggests that sugar substitutes (SUC and STE) may be an unrecognized cause of GI symptoms in some IBS patients. Disclosure: A. Gupta: No Conflicts; J. Baker: No Conflicts; J. Farida: No Conflicts; E. Haller: No Conflicts; L. Watts: No Conflicts; M. Armstrong: No Conflicts; G. Ezell: No Conflicts; W. D. Chey: Allergan: Consulting; alnylam: Consulting; biomerica: Consulting; im health: Consulting; ironwood: Consulting; Phathom: Consulting; QOL Medical: Consulting; Ritter: Consulting; Salix/Valeant: Consulting; Urovant: Consulting;
  20. SAFETY AND EFFICACY EVALUATION OF PLECANATIDE FOR THE TREATMENT OF CHRONIC IDIOPATHIC CONSTIPATION AND IRRITABLE BOWEL SYNDROME-CONSTIPATION IN PATIENTS AGED 65 YEARS OR OLDER Author(s): Stacy B. Menees1, Jonathan Rosenberg2, Reema Patel3, William D. Chey4 Introduction: Chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) are common functional gastrointestinal disorders that likely represent a spectrum of disease. The prevalence of constipation-related complaints tends to increase with age. There are limited data regarding safety and efficacy of guanylate cyclase-C receptor agonists in the elderly. This analysis pooled data from plecanatide phase 3 trials in CIC and IBS-C to assess its safety and efficacy in patients aged ≥65 years (yrs). Methods: Populations from 2 CIC and 2 IBS-C trials of patients randomized to plecanatide 3 mg, plecanatide 6 mg, or placebo were combined for post hoc analysis. Treatment-emergent adverse events (TEAEs) were collected and are reported for patients ≥65 yrs and <65 yrs old, using descriptive statistics. The 4 trials shared a number of secondary efficacy endpoints related to constipation that allowed the CIC and IBS-C trial populations to be combined: changes in stool consistency (Bristol Stool Form Scale [BSFS]), changes in the weekly frequency of complete spontaneous bowel movements (CSBMs) and spontaneous bowel movements (SBMs), and time from start of therapy to first CSBM and first SBM. Results: The pooled safety population comprised 468 patients aged ≥65 yrs (mean: 70.0 yrs) and 4505 patients aged <65 yrs (mean: 42.0 yrs), of whom 302 and 3017, respectively, were randomized to plecanatide. The most common TEAE was diarrhea (Table 1), with rates in the pooled plecanatide dose groups similar in the older and younger cohorts. No cases of serious diarrhea were reported. Rates of discontinuation and diarrhea-related discontinuation in the plecanatide groups were low in both the older and younger cohorts. No new safety signals were observed. Efficacy data for patients aged ≥65 yrs were consistent with those in the full study populations and patients aged <65 yrs (Table 2). There were statistically significant improvements in stool consistency from baseline with plecanatide 3 and 6 mg versus placebo at Week 12, both in patients aged ≥65 yrs and in those aged <65 yrs. Changes from baseline in mean weekly CSBM frequency and mean weekly SBM frequency at Week 12 were numerically greater in the plecanatide groups, compared with placebo; differences were statistically significant versus placebo in the plecanatide 3 mg group in patients aged ≥65 yrs and in both plecanatide groups in patients aged <65 yrs. Furthermore, the times from the start of therapy to first CSBM and first SBM were significantly shorter in the plecanatide groups than in the placebo group in patients aged <65 yrs (P< 0.001 for both) and in patients aged ≥65 yrs. Discussion: Results, which include a meaningful number of elderly patients, indicate that plecanatide is a well-tolerated and effective treatment option for patients aged ≥65 yrs with CIC and IBS-C. Disclosure: S. B. Menees: No Conflicts; J. Rosenberg: No Conflicts; R. Patel: Bausch Health: Employment; W. D. Chey: Allergan: Consulting; alnylam: Consulting; biomerica: Consulting; im health: Consulting; ironwood: Consulting; Phathom: Consulting; QOL Medical: Consulting; Ritter: Consulting; Salix/Valeant: Consulting; Urovant: Consulting;
  21. PROBIOTICS FOR THE PREVENTION OF CLOSTRIDIUM DIFFICILE INFECTION AMONG PATIENTS UNDERGOING ANTIBIOTIC THERAPY Author(s): Alina Popescu1, Camelia G. Foncea1, Raluca Lupusoru1, Mirabela M. Topan1, Radu Cotrau1, Tudor V. Moga1, Andrada-Patricia Belintan1, Mirela Danila1, Roxana Sirli1, Ioan Sporea1 Background and Aim: Clostridium difficile infection (CDI), is the leading cause of antibiotic-associated diarrhea (AAD), a disease which increased in incidence and severity over the last years. Antibiotics exposure is considered the most significant risk factor for CDI among eldery and hospitalized patients. Probiotics have been proposed for the prevention and treatment of a variety of gastrointestinal conditions, but guidelines do not recommend probiotic use for prevention of CDI (1). The aim of this study is to evaluate the efficacy of probiotics in preventing CDI. Materials and methods: an unblinded, randomized, prospective study (October 2018- May 2019) was performed, in which 168 patients admitted in a gastroenterology department, who fulfilled the inclusion criteria and received antibiotics, regardless the indications, were included. Four arms of study were created: three with probiotics and one group placebo. The patients received probiotics in less than 24 hours from the first antibiotic dose, during the treatment and 7 days after, according to their dose indication. Strains such as Lactobacillus, Clostridium Butiricum, Bacilus Mesentericus, Bifidobacterium and Streptococcus faecalis were used. Primary and secondary outcomes were frequency of AAD and CDI and adverse events. Results: Out of 168 patients included (74 female, 94 male, mean age 65±12 years, mean hospitalization days 7.5±6.1), 32.7%(55/168) were on placebo and 67.3%(113/168) received probiotics. Other risk factors for CDI accounted were: use of proton pomp inhibitors 19.6%(33/168) patients, 44%(74/168) patients with age >65 years, liver cirrhosis 43.5%(73/168) patients. 12.5%(21/168) of patients developed AAD, 31%(17/55) patients from the placebo group and 3.5%(4/113) patients on probiotics (p<0.0001). Out of 168 patients, 4.8%(8/168) were confirmed with CDI, 13%(7/55) patients from placebo group and only 0.9% (1/113) patient on probiotics (p=0.0006). Patients exposed to antibiotics, without taking probiotics had a higher risk of CDI: OR=16.3, CI 95% (1.95-136), p=0.0099 . In the probiotics group, probiotics showed a protective role for CDI, OR= 0.06, CI 95% (0.007-0.51), p=0.009. None of the patients reported adverse events. Conclusions: The rate of AAD and CDI was significantly lower in the probiotics group, contrary with placebo group, in which patients had 16 times higher risk to develop CDI. References: 1. Christine SM Lau and Ronald S Chamberlain. Probiotics are effective at preventing Clostridium difficile-associated diarrhea: a systematic review and meta-analysis. Int J Gen Med. 2016; 9: 27–37.Published online 2016 Feb 22. doi: 10.2147/IJGM.S9828 Disclosure: A. Popescu: Abbvie: Speaking and Teaching; General Electric: Speaking and Teaching; Neola: Speaking and Teaching; Philips: Speaking and Teaching; C. G. Foncea: No Conflicts; R. Lupusoru: No Conflicts; M. M. Topan: No Conflicts; R. Cotrau: No Conflicts; T. V. Moga: No Conflicts; A. Belintan: No Conflicts; M. Danila: No Conflicts; R. Sirli: Abbvie: Speaking and Teaching; General Electric: Speaking and Teaching; Neola: Other Activities Not in List ; Philips: Speaking and Teaching; Sanofi: Other Activities Not in List ; Zentiva: Speaking and Teaching; I. Sporea: Abbvie: Speaking and Teaching; General Electric: Speaking and Teaching; MSD: Speaking and Teaching; Neola: Speaking and Teaching; Philips: Advisory Committees or Review Panels; Sanofi: Speaking and Teaching; Siemens: Advisory Committees or Review Panels; Toshiba/Canon: Speaking and Teaching;
  22. EPIDEMIOLOGY OF PSYCHIATRIC DISORDERS IN IRRITABLE BOWEL SYNDROME IN THE UNITED STATES BETWEEN 2014 AND 2019: A POPULATION-BASED NATIONAL STUDY Author(s): Fangyuan Jin-Dominguez1, Emad Mansoor1, Richard C. Wong1, Gregory S. Cooper1 Background Irritable bowel syndrome (IBS) is the most common functional gastrointestinal disorder. Although dysregulation of the gut-brain axis has been proposed and generally well accepted as one of the etiologies of IBS, there are still a lack of studies with a large sample size to describe the correlation between IBS and psychiatric co-morbidities. We aimed to describe the prevalence of generalized anxiety disorder (GAD), major depressive disorder (MDD), panic disorder, bipolar disorder and schizophrenia in patients with IBS in the United States (US) between 2014 and 2019 utilizing a large population based database. Methods We queried a commercial database (Explorys Inc, OH), an aggregate of EHR data from 26 major integrated healthcare systems in the US from 1999 to 2019. We identified an aggregated patient cohort of eligible patients with a diagnosis of IBS with GAD, MDD, panic disorder, bipolar disorder and schizophrenia between 2014 and 2019 based on the Systematized Nomenclature of Medicine-Clinical Terms. We also identified patients with a diagnosis of these five psychiatric disorders without IBS. We calculated the prevalence and odds ratio of GAD, MDD, panic disorder, bipolar disorder and schizophrenia in IBS among various patient groups by age, gender and race. Results Of the 709,360 patients in the database with IBS, 122,690 had GAD, 233,940 had MDD, 46,550 had panic disorder, 49,740 had bipolar disorder, and 11,320 had schizophrenia, with prevalence of 17.3%, 33.0%, 6.6%, 7.0% and 1.6%, respectively (Table 1). The prevalence of these five disorders are higher among IBS patients than the group without IBS with prevalence of 3.3%, 8.0%, 1.1%, 1.8% and 0.51%, respectively. Adults (age 18 to 65 years old), females and Caucasians have higher prevalence of GAD, MDD, and panic disorder. Adults, females and African Americans have higher prevalence of bipolar disorder. Schizophrenia is more prevalent in adults, males and Asians. Juniors (age less than 18) have the lowest prevalence in all five disorders compared to adults and seniors. Furthermore, there is significantly increased likelihood for IBS patients to be diagnosed with GAD (OR 6.07, 95%CI: 6.03-6.11, p<0.0001), MDD (OR 5.64, 95%CI: 5.61-5.67, p<0.0001), panic disorder (OR 6.19, 95%CI: 6.13-6.25, p<0.0001), bipolar disorder (OR 4.23, 95%CI: 4.19-4.27, p<0.0001) and schizophrenia (OR 3.18, 95% CI: 3.12-3.24, p<0.0001) (Figure 1). Conclusion This is one of the largest population-based national studies that describes prevalence of GAD, MDD, panic disorder, bipolar disorder and schizophrenia in IBS patients. We found IBS patients are three to six times more likely to be diagnosed with these psychiatric disorders compared to those without IBS. We advocate to screen IBS patients for these psychiatric disorders as part of a holistic approach to achieve optimal patient care. Disclosure: F. Jin-Dominguez: No Conflicts; E. Mansoor: No Conflicts; R. C. Wong: Vascular Technology, Inc.: Consulting, Grant/Research Support; G. S. Cooper: No Conflicts;
  23. USEFULNESS OF FECAL CALPROTECTIN IN PRIMARY CARE. NON-INVASIVE APPROACH FOR THE FRAMING OF INTESTINAL DISEASES Author(s): Florenzo Moccia2, Alberto Barchi2, Marilisa Franceschi3, Michele Russo2, Chiara Miraglia2, Antonio Ferronato2, Antonio Antico5, Maria Piera Panozzo5, Gianluca Baldassarre3, Antonio Tursi6, Giovanni Brandimarte4, Lorella Franzoni1, Pellegrino Crafa2, Francesco Di Mario2 Introduction and Aim: Faecal Calprotectin (FC) is a marker of intestinal inflammation. Many studies show the usefulness of FC as a diagnostic tool in IBD in gastroenterology; there are, instead, fewer works that study FC in primary care. The aims of this study were: evaluating the link between FC and endoscopic and histological findings after Colonoscopy, rating of PPV (positive predictive value) and NPV (negative predictive value) of FC in different gastrointestinal lower diseases and their changes with the change of cut off (with the study of ROC curve). Material and Methods A cohort of 2487 laboratory exams of FC were selected in 2018. 1945 of these were requested by the General Practitioner (78.2%) and the other 450 exams by Gastroenterologists (18.1%) which were excluded from the analysis. We also excluded 79 exams (3.2%) which were required to pediatric population (age < 10 years) and 13 exams (0.5%) linked to unfinished colonoscopies. The study population was thus composed by 778 men (40.0%) and 1167 women (60.0%), mean age 50.9 years (range 10-96). According to the literature, 3 cut-off values were selected for this exam: 0-49 μg/g was considered negative, 50-149 μg/g was considerate indeterminate and ≥150 was considerate positive. 303 of them (21.1%) also underwent to a Colonoscopy between January 2018 and May 2019. Results The results of 1945 fecal calprotectin were: negative n. 1427 (73.3%), indeterminate n. 349 (17.9%) and positive n. 169 (8.8%). The findings of 303 Colonoscopies were: 136 negatives (44.9%), 56 Diverticular Disease (18.4%), 33 polyps (10.9%), 46 IBD (15.2%), 25 others colitis (8.3%), 7 neoplasia (2.3%). Table 1 shows FC values in each group. Using ROC curve, we found significance for IBD (AUC = 0.826), Others Colitis (AUC = 0.848) and for neoplasia (AUC = 0.783). ROC curves suggest using only a cut off (80 μg/g). Using the previous cuts off we found that this tool had PPV of 76.3% and NPV of 60.1%; the accuracy of the test was 64.2%. With the cut off (80 μg/g) PPV was 83.5% and NPV was 58.3%; the accuracy of the test increases up to 66.4%. Conclusions: FC's ability to identify patients with inflammatory diseases (IBD and other non-IBD colitis) is confirmed. FC is a useful tool in primary care setting for reducing colonoscopy prescriptions and increasing their appropriateness. Finally, the diagnostic efficacy of the proposed new FC cut-off (80 μg/g) has been demonstrated. Disclosure: F. Moccia: No Conflicts; A. Barchi: No Conflicts; M. Franceschi: No Conflicts; M. Russo: No Conflicts; C. Miraglia: No Conflicts; A. Ferronato: No Conflicts; A. Antico: No Conflicts; M. Panozzo: No Conflicts; G. Baldassarre: No Conflicts; A. Tursi: No Conflicts; G. Brandimarte: No Conflicts; L. Franzoni: No Conflicts; P. Crafa: No Conflicts; F. Di Mario: No Conflicts;
  24. THE CLINICAL OUTCOMES OF CLOSTRIDIUM DIFFICILE INFECTION IN IRRITABLE BOWEL SYNDROME PATIENTS: THE US NATIONWIDE ANALYSIS 2004-2014 Author(s): Abdullah Sohail1, Ahmad Khan1, Zunaira Mahmood1, Shailendra Singh1 Clostridium difficile infection (CDI) is a healthcare-related diarrheal infection associated with increased morbidity and mortality. CDI clinical outcomes in irritable bowel syndrome (IBS) patients have not much studied. Both IBS and CDI can present with a similar clinical picture. Data on the nationwide trends and associated mortality in IBS is limited. We sought to estimate the national trends of CDI in patients with IBS. Methods: We performed a retrospective analysis of the largest US National Inpatient Sample database for adult patients with a principal diagnosis of CDI with a secondary diagnosis of IBS from 2004 to 2014. We acquired the annual trends of the total number of CDI cases and mortality in these patients for each year. In-hospital mortality, length of stay (LOS), and total hospitalization charges were adjusted for confounding factors such as age, gender, race, Charlson’s comorbidity index, primary insurance, and hospital teaching status using multivariate regression analysis. Results: A total of 21,772 IBS related hospitalization, with a principal diagnosis of CDI, were identified from 2004 to 2014. These represented 1.08 % of all hospitalizations for IBS. Patients discharged with CDI were older (mean age 60 vs. 59 years, p<0.001), and more likely to be Caucasians (88% vs. 86.32%, p< 0.001) as compared to other IBS patients. These patients were more frequently admitted in the hospitals in the South (37.2%) and Midwest (26.8%) regions of the United States (p<0.01). The number of CDI cases increased by 215 % (1084 to 3420, p<0.01) from the year 2005 to 2014. The total mortality rate observed in CDI cases with IBS was 0.69 % (n=152). However, mean LOS (5.5 days vs. 6.6 days) and mean total hospitalization charges (27,001 vs. 33,838) were lower in the CDI group as compared to the non-CDI group. On multivariate regression analysis, age (adj OR 1.05, P<0.001) and Charlson comorbid index category 1,2 and >3 (adj OR 1.48, P<0.001, adj OR 1.86, P<0.001, adj OR: 2.53, P<0.001) were found to be independent predictors of mortality in these patients. Conclusion: Our study demonstrated that the number of CDI related hospitalizations in IBS patients has increased by more than threefold in a decade. It is imperative not to overlook the CDI as a cause of diarrhea, especially in patients with diarrhea-predominant IBS. Disclosure: A. Sohail: No Conflicts; A. Khan: No Conflicts; Z. Mahmood: No Conflicts; S. Singh: No Conflicts;
  25. CANNABIS USE IS ASSOCIATED WITH REDUCED 30-DAY READMISSION AMONG HOSPITALIZED PATIENTS WITH IRRITABLE BOWEL SYNDROME: A NATIONWIDE ANALYSIS Author(s): Catherine Choi1, Marwan S. Abougergi2,3, Heather Peluso4, Preet Patel1, Nikolaos Pyrsopoulos1 Background: Recent studies demonstrated the biological roles of endocannabinoid system in the gastrointestinal tract, and therefore cannabinoid receptors are the potential therapeutic targets for the gastrointestinal tract disorders. We hypothesize that cannabis use is associated with better control of irritable bowel syndrome (IBS) compared to those without cannabis use. This study aimed to evaluate the utilization of inpatient services patients with IBS with and without cannabis use. Methods: This is a retrospective cohort study utilizing the 2016 Nationwide Readmissions Database. Inclusion criteria were principal diagnosis of IBS using ICD-10 CM codes. Exclusion criteria were age <18 years. The exposure of interest was cannabis. The primary outcome was rate of 30-day readmission with and without cannabis use. Secondary outcomes were most common reasons for readmission and resource utilization: 1) length of stay (LOS) and 2) total hospitalization charges and costs. Multivariate regression analysis was used to adjust for confounders (age, sex, median income in the patient’s zipcode, insurance, Charlson comorbidity score, hospital bedsize, teaching status and location) and identify independent risk factors for readmission. Results: A total of 6,798 patients with the diagnosis of IBS were identified, 357 of whom used cannabis. For patients with and without cannabis use, the mean age was 36.7 (34.5-38.9) and 53.3 (52.6-54.1) respectively, 62% and 81% were female, respectively. The all cause 30-day readmission rates were 8.1% and 12.7% for patients with and without cannabis use, respectively. After adjusting for confounders, the odds of 30-day readmission were lower among patients who use cannabis compared with those who do not (aOR: 0.53, 95% CI (0.28-0.99)). The most common 3 reasons readmission for patients who do not use cannabis were enterocolitis due to Clostridium difficile, IBS without diarrhea, and sepsis, while they were cyclical vomiting, IBS with diarrhea, and endometriosis for those how did (Table 1). Independent predictors of readmission were age, private insurance and home health care among patients who did not use cannabis (Table 2). No factor analyzed predicted readmission among patients who use cannabis. Cannabis use was also associated with shorter length of stay (adjusted mean difference:aMD: - 0.44 (-0.85 - -0.03) days, p=0.036) and total hospitalization charges: (aMD: -$3,473 (-$46,773 - -$174), p=0.04). Cannabis use was associated with higher survival rate than no-cannabis use group (Figure 1). Conclusion: The all cause 30-day readmission rates were 12.7% in no cannabis and 8.1% in cannabis group. Cannabis use is associated with reduced 30-day readmission rates among patients with IBS after adjusted for age, sex, income, insurance, status, CCI, hospital bed-size and teaching status. Disclosure: C. Choi: No Conflicts; M. S. Abougergi: No Conflicts; H. Peluso: No Conflicts; P. Patel: No Conflicts; N. Pyrsopoulos: ABBVIE: Grant/Research Support; BAYER: Grant/Research Support; GENFIT: Grant/Research Support; GILEAD: Grant/Research Support; INTERCEPT: Grant/Research Support; Mallinckrodt: Grant/Research Support; PROMETHEUS: Grant/Research Support; SALIX: Grant/Research Support;
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