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Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | Ulcerative Colitis | Study protocol

Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial

Authors: Caroline Trang-Poisson, Elise Kerdreux, Alexandra Poinas, Lucie Planche, Harry Sokol, Pascale Bemer, Karine Cabanas, Eliane Hivernaud, Laetitia Biron, Laurent Flet, Emmanuel Montassier, Ghislaine Le Garcasson, Anne Chiffoleau, Alexandra Jobert, Didier Lepelletier, Jocelyne Caillon, Patrice Le Pape, Berthe-Marie Imbert, Arnaud Bourreille

Published in: Trials | Issue 1/2020

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Abstract

Background

Almost 15% of patients with ulcerative colitis (UC) will require a proctocolectomy with ileal pouch–anal anastomosis (IPAA) as a result of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Around 50% will experience pouchitis, an idiopathic inflammatory condition involving the ileal reservoir, responsible for digestive symptoms, deterioration in quality of life, and disability. Though the majority of initial cases of pouchitis are easily managed with a short course of antibiotics, in about 10% of cases, inflammation of the pouch becomes chronic with very few treatments available.
Previous studies have suggested that manipulating the composition of intestinal flora through antibiotics, probiotics, and prebiotics achieved significant results for treating acute episodes of UC-associated pouchitis. However, there is currently no established effective treatment for chronic antibiotic-dependent pouchitis. Fecal microbiota transplantation (FMT) is a novel therapy involving the transfer of normal intestinal flora from a healthy donor to a patient with a medical condition potentially caused by the disrupted homeostasis of intestinal microbiota or dysbiosis.

Methods

Our project aims to compare the delay of relapse of chronic recurrent pouchitis after FMT versus sham transplantation. Forty-two patients with active recurrent pouchitis after having undergone an IPAA for UC will be enrolled at 12 French centers. The patients who respond to antibiotherapy will be randomized at a ratio of 1:1 to receive either FMT or sham transplantation.

Discussion

On April 30, 2014, the World Health Organization published an alarming report on antibiotic resistance. Finding an alternative medical treatment to antibiotics in order to prevent relapses of pouchitis is therefore becoming increasingly important given the risk posed by multiresistant bacteria. Moreover, if the results of this study are conclusive, FMT, which is less expensive than biologics, could become a routine treatment in the future.

Trial registration

ClinicalTrials.gov, NCT03524352. Registered on 14 May 2018.
Appendix
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Metadata
Title
Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial
Authors
Caroline Trang-Poisson
Elise Kerdreux
Alexandra Poinas
Lucie Planche
Harry Sokol
Pascale Bemer
Karine Cabanas
Eliane Hivernaud
Laetitia Biron
Laurent Flet
Emmanuel Montassier
Ghislaine Le Garcasson
Anne Chiffoleau
Alexandra Jobert
Didier Lepelletier
Jocelyne Caillon
Patrice Le Pape
Berthe-Marie Imbert
Arnaud Bourreille
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04330-1

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