Evidence map›Paper›PMID 32493442›Full record

ArticleTrials2020

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.

Caroline Trang-Poisson, Elise Kerdreux, Alexandra Poinas, Lucie Planche, Harry Sokol, Pascale Bemer, Karine Cabanas, Eliane Hivernaud, Laetitia Biron, Laurent Flet and 9 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03524352 (Prospective Multicenter Randomized Controlled Double-blind Label Study of the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03524352 phase3active not recruitingnot on this map

Prospective Multicenter Randomized Controlled Double-blind Label Study of the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis

TypeinterventionalSponsorNantes University HospitalRan2020 to 2028Enrolled42ConditionsPouchitisArmsfecal microbiota, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Fecal Microbiota Transplantation Attenuated Inflammation Through TGF-β1/Smad Signaling Pathway in Caco-2 and RAW264.7 Cells.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2025
    Article
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 2 institutions in 1 country.

Caroline Trang-PoissonGastroenterology Department, Institute of Digestive Diseases (Institut des Maladies de l'Appareil Digestif - IMAD), CHU Nantes and Nantes University, Nantes, France.
Elise KerdreuxGastroenterology Department, Institute of Digestive Diseases (Institut des Maladies de l'Appareil Digestif - IMAD), CHU Nantes and Nantes University, Nantes, France.
Alexandra PoinasClinical Investigation Centre CIC1413, CHU Nantes and INSERM, Nantes, France. alexandra.poinas@chu-nantes.fr.ORCID http://orcid.org/0000-0003-4183-483X
Lucie PlancheMethodology and Biostatistics Unit, Delegation to Clinical Research and Innovation for CHU Nantes and Vendée departmental Hospital, Nantes, La Roche sur Yon, France.
Harry SokolSorbonne Université, Inserm, Centre de Recherche Saint-Antoine, CRSA, AP-HP, Hôpital Saint Antoine, Gastroenterology & Nutrition Department, F-75012, Paris, France.
Pascale BemerMiHAR lab, Nantes University, 44000, Nantes, France.
Karine CabanasGastroenterology Department, Institute of Digestive Diseases (Institut des Maladies de l'Appareil Digestif - IMAD), CHU Nantes and Nantes University, Nantes, France.
Eliane HivernaudGastroenterology Department, Institute of Digestive Diseases (Institut des Maladies de l'Appareil Digestif - IMAD), CHU Nantes and Nantes University, Nantes, France.
Laetitia BironSponsor Department, CHU Nantes, Nantes, France.
Laurent FletPharmacy Department, CHU Nantes, Nantes, France.
Emmanuel MontassierMiHAR lab, Nantes University, 44000, Nantes, France.
Ghislaine Le GarcassonMiHAR lab, Nantes University, 44000, Nantes, France.
Anne ChiffoleauSponsor Department, CHU Nantes, Nantes, France.
Alexandra JobertSponsor Department, CHU Nantes, Nantes, France.
Didier LepelletierBacteriology and Infection Control Department, CHU Nantes, 44000, Nantes, France.
Jocelyne CaillonBacteriology and Infection Control Department, CHU Nantes, 44000, Nantes, France.
Patrice Le PapeParasitology-Mycology Department, Institute of Biology CHU Nantes, Nantes, France.
Berthe-Marie ImbertVirology Department, CHU Nantes, Nantes, France.
Arnaud BourreilleGastroenterology Department, Institute of Digestive Diseases (Institut des Maladies de l'Appareil Digestif - IMAD), CHU Nantes and Nantes University, Nantes, France.
Centre Hospitalier Universitaire de Nantes · FRInserm · FR

Funding

Ministère des Affaires Sociales, de la Santé et des Droits des Femmes 16-267
6 · The paper itself

Abstract

backgroundAlmost 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.

methodsOur 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 registrationClinicalTrials.gov, NCT03524352. Registered on 14 May 2018.

Indexed as

Fecal Microbiota TransplantationAnti-Bacterial AgentsChronic DiseaseColitis, UlcerativeDouble-Blind MethodFranceHumansMulticenter Studies as TopicPouchitisProctocolectomy, RestorativeProspective StudiesQuality of LifeRandomized Controlled Trials as TopicRecurrenceAnti-Bacterial AgentsFecal microbiota transplantationIleal pouch–anal anastomosisPouchitisRandomized controlled trials

Identifiers

PMID32493442
PMCPMC7267479
OpenAlexW3032614125

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.