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Fecal Microbiota Transplantation (FMT) is a new treatment where healthy stool donor is transplanted into the colon of the patient. Detailed explanation: Fecal Matter Transplantation (FMT) is a procedure where a fecal solution from a donor is deposited into the intestinal tract of a recipient. To complete the procedure, the fresh or frozen stool of the donor, is dissolved in a salt water solution. The fecal matter is usually deposited using a tube that goes straight into the digestive tract. The treatment is generally recognized as safe. Most patients experience diarrhea on the day of the procedure, and a small percentage report belching, abdominal cramping or constipation. At this time there is limited research on its effectiveness in IBS patients. In the small body of evidence currently available, researchers focused on the effects of fecal transplants in patients with constipation-dominant IBS. Patients who received the transplantation reported improvements in stool frequency and less bloating and pain. FMT has been highly successful in patients suffering from an overgrowth of the bacteria Clostridium Difficile, a bacteria infection in the bowel that can be fatal and very difficult to treat. Does anyone have experience with this?

FECAL MICROBIOTA TRANSPLANTATION (FMT) FOR IRRITABLE BOWEL SYNDROME (IBS): A SYSTEMATIC REVIEW AND META-ANALYSIS AuthorBlock: Dhruvan Patel1, Anisha Daxini2, Ramkaji Baniya3, Neilanjan Nandi1, Asyia S. Ahmad1 1Gastroenterology, Drexel University College of Medicine, Philadelphia, Pennsylvania, United States; 2Internal Medicine, Mercy Nazareth Hospital, Philadelphia, Pennsylvania, United States; 3Internal Medicine, Our Lady of the Lake Regional Medical Center, Baton Rouge, Louisiana, United States; Background: In recent years, the role of FMT in the treatment of IBS has been receiving increased attention from researchers. However, there are limited randomized controlled trials (RCTs) on the effectiveness of FMT in IBS. On extensive literature search, there is no meta-analysis performed on FMT effectiveness in IBS. We thus performed this systematic review and meta-analysis assessing the effectiveness of FMT in IBS patients. Methods: PubMed, Cochrane Library, Scopus, Clinicaltrials.gov, Clinicalkey, Ovid Medline and CINAHL databases were searched for all studies published up to December 2018 assessing the use of FMT in IBS. Primary outcome was clinical improvement in IBS symptoms at 3 months after FMT (50 or 75 points reduction in IBS-SSS score or self-reported). Secondary outcome was change in quality of life (QoL) at 3 months after FMT based on IBS-QoL scores. Non-RCT studies and RCTs with no clinical outcome data were excluded. Pooled effect sizes and 95% confidence intervals (CI) were obtained using the random effects model. We calculated odds ratios (ORs) for categorical variables and mean differences for continuous variables. The Mantel-Haenszel method and random effect models were used to analyze the data. Results: A total of 18 studies (6 RCTs, 4 open label studies, 3 retrospective studies, 4 case series, 1 case report) were identified assessing the effectiveness of FMT in IBS (Table 1). Only 4 RCTs met the inclusion criteria and total 246 IBS patients were included. A total of 142 IBS patients received FMT and 97 IBS patients received the placebo treatments, of which 74 (52%) in FMT and 50 (51.5%) in the placebo group achieved IBS symptoms improvement at 3 months. In the meta-analysis, no significant difference was noted between the placebo and FMT group. [OR:0.89 (95% CI:0.22-3.62), p=0.87] with high heterogeneity (I2= 84%) (Figure 1). Heterogeneity was noted because of diversity in the mode of FMT administration, different IBS-SSS score criteria as outcomes, and different population with inconsistency in IBS phenotypes. Sub-analysis demonstrated significant IBS symptoms improvement at 3 months in non-capsule FMT group compared to placebo. [OR:2.94 (95% CI:1.42-6.08),p=0.004] with no heterogeneity (I2= 0%). Interestingly, the QoL scores were higher at 3 months in the placebo groups compared to FMT groups. [mean difference in score from baseline: 6.70 (95% CI:13.52 to 0.13,p=0.05)] with moderate heterogeneity (I2= 39%) (Figure 1). Most adverse events were transient gastrointestinal complains. Conclusion: FMT does not appear to be more effective than placebo for the treatment of IBS. However, FMT utilizing non-capsule routes of administration appears to significantly reduce IBS symptoms at 3 months compared to placebo. Future studies assessing the effectiveness of FMT in IBS should consider not to use the capsule as a mode of delivery. Table 1. Systematic review on the effectiveness of FMT in IBS patients Study type Author Patients FMT vs Placebo Route Dose Frequency Improvement in IBS symptoms Improvement in IBS-QoL score from baseline RCT Aroniadis et al (2018) USA 48 (IBS-D) 24 vs 24 Capsule 25 cap/d containing 50gm feces 3 days 10/24 (48%) vs 15/24 (63%) (p=0.32) IBS-SSS score reduction >50 points at 3 months from baseline 12±5 vs 14±5 (p=0.62) at 3 months RCT Halkjaer et al (2018) DENMARK 51 (all types of IBS) 25 vs 26 Capsule 25 cap/d containing 50gm feces 12 days 8/22 (36%) vs 19/24 (79%) (p=0.008) IBS-SSS score reduction >50 points at 3 months from baseline 7±10 vs 16±10 (p=0.003) at 3 months RCT Holvent et al (2018) BELGIUM 64 IBS with bloating 42 vs 22 Naso-jejunal N/A Once 20/41(49%) vs 6/21(29%) (P=0.004) Self-reported improvements in IBS/bloating symptoms at 3 months 16% in FMT group, no data for placebo at 3 months RCT Johnsen et al (2018) NORWAY 83 (IBS-M, IBS-D) 55 vs 28 Colonoscopy 50-80 gm of feces in 200 ml saline Once 36/55 (65%) vs 12/28 (43%) (P=0.049) IBS-SSS score reduction >75 points at 3 months from baseline N/A RCT Holster et al (2018) SWEDEN 16 (all types of IBS) 8 vs 8 Colonoscopy N/A Once in IBS-SSS score 63.3±43 at 2 months in FMT group, no data in placebo 10.0 ± 6.3 in FMT group (at 2 months), no data in placebo RCT Bruno et al (2018) ITALY 3 (IBS-D, IBS-U) 3 vs 0 Enema N/A at 0 and 3 weeks 2/3 (66%) at 6weeks in FMT group N/A Open label study Beurden et al (2017) 10 (antibiotic as well as post-infectious IBS) N/A Naso- Duodenal 198 ml donor feces Once 4/10 (40%) (IBS-SSS score reduction >30% at 2 months from baseline 15% in FMT group (at 2 months) Open label study Holvent et al (2016) 12 IBS-D, bloating N/A Colonoscopy 300 ml donor feces Once 9/12(75%) at 3 months 13% in FMT group (at 3 months) Open label study Mizuno et al (2017) 10 All types of IBS N/A Colonoscopy 100 gm feces in 200 ml NS Once 6/10 (60%) at 1 month N/A Open label study Cruz et al (2015) 9 (IBS-C and IBS-D) N/A Colonoscopy and enema N/A Once 6/9 (66%) at 3 months N/A Retrospective study Pinn et al (2014) 13 All type of IBS N/A Jejunal or Duodenal 50-100 ml donor feces Once 9/13 (70%) at 11 months N/A Retrospective study Li et al (2017) 15 N/A N/A N/A N/A 11/15 (73.3%) N/A Case report Andrews et al (1992) 1 IBS-C N/A Enema N/A 2 days 1/1 (100%) at 18 months N/A Case series Borody et al (2004) 3 IBS-C N/A Enema N/A 5 days 3/3 (100%) at 8-28 months N/A Case series Hong et al (2016) 10 N/A N/A N/A N/A 8/10 (80%) patients at 1 month N/A Case series Syzneko et al (2016) 12 all type of IBS N/A Colonoscopy N/A Once 9/12 (75%) at 1 month N/A Case series Mazzawi et al (2016) 9 IBS-D N/A N/A N/A N/A Reduction in IBS-SSS score (p=0.0002) and Bristol stool scale (p=0.02) at 3 weeks N/A Retrospective study Vivekanandrajah et al (2017) 15 IBS-D, IBS-C N/A Colonoscopy or enema N/A N/A Reduction in daily BM post-treatment in IBS-D (p<0.05) N/A

Research study: A Pilot Study to Evaluate Fecal Microbiota Transplantation in Irritable Bowel Syndrome Location: Boston, Massachusetts Inclusion Criteria: IBS with diarrhea The study is to evaluate whether we can change the microbiome of individuals with IBS using a healthy donor. We then would like to see whether if we are able to change the microbiome, if there's a resulting improvement in symptoms. We randomize people to receive either a fecal transplant or a placebo fecal transplant. People are also receiving an antibiotic either rifaximin, a combination of Cipro/flagyl or no antibiotic as a pre-treatment. The capsule form of fecal matter transplant (FMT) is being used. Contact: Vivian Cheng 617.667.0682 [email protected] Principal Investigator: Anthony Lembo, MD, Beth Israel Deaconess Medical Center More clinical trials listed here: https://www.ibspatient.org/clinical-trials