Fecal microbiota transplantation to maintain remission in Crohn’s disease: a pilot randomized controlled study

Abstract

Background: The role of the gut microbiota in Crohn's disease (CD) is established and fecal microbiota transplantation (FMT) is an attractive therapeutic strategy. No randomized controlled clinical trial results are available. We performed a randomized, single-blind, sham-controlled pilot trial of FMT in adults with colonic or ileocolonic CD. Method: Patients enrolled while in flare received oral corticosteroid. Once in clinical remission, patients were randomized to receive either FMT or sham transplantation during a colonoscopy. Corticosteroids were tapered and a second colonoscopy was performed at week 6. The primary endpoint was the implantation of the donor microbiota at week 6 (Sorensen index > 0.6). Results: Eight patients received FMT and nine sham transplantation. None of the patients reached the primary endpoint. The steroid-free clinical remission rate at 10 and 24 weeks was 44.4% (4/9) and 33.3% (3/9) in the sham transplantation group and 87.5% (7/8) and 50.0% (4/8; one patient loss of follow-up while in remission at week 12 and considered in flare at week 24) in the FMT group. Crohn's Disease Endoscopic Index of Severity decreased 6 weeks after FMT (p = 0.03) but not after sham transplantation (p = 0.8). Conversely, the CRP level increased 6 weeks after sham transplantation (p = 0.008) but not after FMT (p = 0.5). Absence of donor microbiota engraftment was associated with flare. No safety signal was identified. Conclusion: The primary endpoint was not reached for any patient. In this pilot study, higher colonization by donor microbiota was associated with maintenance of remission. These results must be confirmed in larger studies (NCT02097797).

Fecal microbiota transplantation in inflammatory bowel disease patients: A systematic review and meta-analysis

“…The list of the 60 included references is provided in the Supplemental Digital Content (S1 Table). The 36 records included in the quantitative synthesis comprised all the quasi-experimental studies and RCTs [45][46][47][48][49][50][51][52][53]. Data on these studies are provided in Table 1.…”

Dusp6 Depletion Enhances Gut Barrier Integrity and Microbiota Eubiosis Against Dextran Sulfate Sodium-Induced Colitis in Mice

“…For UC, the results from two randomized trials showed that FMT was more effective than placebo control [61,62], but another randomized trial did not show any significant difference between FMT versus control [63]. For Crohn's disease, FMT resulted in clinical improvement in a pilot study that enrolled pediatric patients and a small separate cohort of adults [64], whereas another randomized, single-blind pilot study showed that FMT did not result in clinical improvement but could serve as a maintenance treatment after corticosteroids [65]. Overall, the clinical evidence for the efficacy of FMT in the treatment of IBD is inconclusive, and another randomized clinical trial is ongoing (https://clinicaltrials.gov/ct2/show/NCT03078803).…”

Fecal Microbiota Transplantation for the Treatment of Inflammatory Bowel Disease: An Update

“…Crohn's Disease Endoscopic Index of Severity decreased at 6 weeks in the FMT group (p = 0.03) but not in the control group (p = 0.8). On the contrary, the CRP level increased at 6 weeks in the control group (p = 0.008) but not in the FMT group (p = 0.5) (Sokol et al, 2020). Xiang et al (2020) believed that FMT in CD against targeted therapeutics was efficient, especially hematochezia, abdominal pain, diarrhoea and fever.…”

“…The evidence on the effect of FMT in CD has recently been presented. There are currently several active trials studying the effectiveness of FMT for CD, and the results are diverse ( Table 2) (Cui et al, 2015;Suskind et al, 2015;Wei et al, 2015;Vaughn et al, 2016;Vermeire et al, 2016;Goyal et al, 2018;Gutin et al, 2019;Sokol et al, 2020;Xiang et al, 2020). Xiang et al (2020) studied 174 CD patients treated with FMT via Mid-gut including nasojejunal tube, endoscopy and mid-gut TET (except one through colonic TET).…”