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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 ileo-colonic 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). Video abstract.

SUBMITTER: Sokol H

PROVIDER: S-EPMC6998149 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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

Sokol Harry H Landman Cecilia C Seksik Philippe P Berard Laurence L Montil Mélissa M Nion-Larmurier Isabelle I Bourrier Anne A Le Gall Guillaume G Lalande Valérie V De Rougemont Alexis A Kirchgesner Julien J Daguenel Anne A Cachanado Marine M Rousseau Alexandra A Drouet Élodie É Rosenzwajg Michelle M Hagege Hervé H Dray Xavier X Klatzman David D Marteau Philippe P Beaugerie Laurent L Simon Tabassome T

Microbiome 20200203 1

<h4>Background</h4>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 ileo-colonic CD.<h4>Method</h4>Patients enrolled while in flare received oral corticosteroid. Once in clinical remission, patients were randomized to receive either ...[more]

PMID: 32014035

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Project description:ImportanceHigh-intensity, aerobically prepared fecal microbiota transplantation (FMT) has demonstrated efficacy in treating active ulcerative colitis (UC). FMT protocols involving anaerobic stool processing methods may enhance microbial viability and allow efficacy with a lower treatment intensity.ObjectiveTo assess the efficacy of a short duration of FMT therapy to induce remission in UC using anaerobically prepared stool.Design, setting, and participantsA total of 73 adults with mild to moderately active UC were enrolled in a multicenter, randomized, double-blind clinical trial in 3 Australian tertiary referral centers between June 2013 and June 2016, with 12-month follow-up until June 2017.InterventionsPatients were randomized to receive either anaerobically prepared pooled donor FMT (n = 38) or autologous FMT (n = 35) via colonoscopy followed by 2 enemas over 7 days. Open-label therapy was offered to autologous FMT participants at 8 weeks and they were followed up for 12 months.Main outcomes and measuresThe primary outcome was steroid-free remission of UC, defined as a total Mayo score of ≤2 with an endoscopic Mayo score of 1 or less at week 8. Total Mayo score ranges from 0 to 12 (0 = no disease and 12 = most severe disease). Steroid-free remission of UC was reassessed at 12 months. Secondary clinical outcomes included adverse events.ResultsAmong 73 patients who were randomized (mean age, 39 years; women, 33 [45%]), 69 (95%) completed the trial. The primary outcome was achieved in 12 of the 38 participants (32%) receiving pooled donor FMT compared with 3 of the 35 (9%) receiving autologous FMT (difference, 23% [95% CI, 4%-42%]; odds ratio, 5.0 [95% CI, 1.2-20.1]; P = .03). Five of the 12 participants (42%) who achieved the primary end point at week 8 following donor FMT maintained remission at 12 months. There were 3 serious adverse events in the donor FMT group and 2 in the autologous FMT group.Conclusions and relevanceIn this preliminary study of adults with mild to moderate UC, 1-week treatment with anaerobically prepared donor FMT compared with autologous FMT resulted in a higher likelihood of remission at 8 weeks. Further research is needed to assess longer-term maintenance of remission and safety.Trial registrationanzctr.org.au Identifier: ACTRN12613000236796.

Dataset Information

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

Publications

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

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