The Effect of Non-pooled Multidonor Faecal Microbiota Transplantation for Inducing Clinical Remission in Patients with Chronic Pouchitis: Results from a Multicentre, Randomised, Double-blinded, Placebo-controlled Trial [MicroPouch]

• Published in: Journal of Crohn's and colitis Vol. 18; no. 11; pp. 1753 - 1766
• Main Authors: Kousgaard, Sabrina Just, Cold, Frederik, Halkjær, Sofie Ingdam, Petersen, Andreas Munk, Kjeldsen, Jens, Hansen, Jane Møller, Dall, Sebastian Mølvang, Albertsen, Mads, Nielsen, Hans Linde, Kirk, Karina Frahm, Duch, Kirsten, Sønderkær, Mads, Thorlacius-Ussing, Ole
• Format: Journal Article
• Language: English
• Published: UK Oxford University Press 04.11.2024
• Subjects: Adult; Chronic Disease; Double-Blind Method; Fecal Microbiota Transplantation - methods; Feces - microbiology; Female; Humans; Male; Middle Aged; Pouchitis - microbiology; Pouchitis - therapy; Remission Induction - methods; Treatment Outcome; microbiota; Faecal microbiota transplantation; pouchitis
• ISSN: 1873-9946; 1876-4479
• DOI: 10.1093/ecco-jcc/jjae066

Abstract Background and Aims To investigate if treatment with non-pooled, multidonor faecal microbiota transplantation [FMT] for 4 weeks was superior to placebo to induce clinical remission in patients with chronic pouchitis. Methods The study was a randomised, double-blinded, placebo-controlled study with a 4-week intervention period and 12-month follow-up. Eligible patients with chronic pouchitis were recruited from five Danish hospitals. Participants were randomised to non-pooled, multidonor FMT derived from four faecal donors, or placebo. Treatment was delivered daily by enema for 2 weeks, followed by every second day for 2 weeks. Disease severity was accessed at inclusion and 30-day follow-up, using the Pouchitis Disease Activity Index [PDAI]; PDAI <7 was considered equivalent to clinical remission. Faecal samples from participants and donors were analysed by shotgun metagenomic sequencing. Results Inclusion was stopped after inclusion of 30 participants who were randomised 1:1 for treatment with FMT or placebo. There was no difference in participants achieving clinical remission between the two groups at 30-day follow-up, relative risk 1.0 (95% CI [0.55; 1.81]). Treatment with FMT resulted in a clinically relevant increase in adverse events compared with placebo, incidence rate ratio 1.67 (95% CI [1.10; 2.52]); no serious adverse events within either group. Faecal microbiota transplantation statistically significantly increased the similarity of participant faecal microbiome to the faecal donor microbiome at 30-day follow-up [p = 0.01], which was not seen after placebo. Conclusions Non-pooled, multidonor FMT was comparable to placebo in inducing clinical remission in patients with chronic pouchitis, but showed a clinically relevant increase in adverse events compared with placebo. ClincialTrials.gov number, NCT04100291. Graphical abstract Graphical Abstract