Evidence map›Paper›PMID 32014035›Full record

Trial reportMicrobiome2020

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

Harry Sokol, Cecilia Landman, Philippe Seksik, Laurence Berard, Mélissa Montil, Isabelle Nion-Larmurier, Anne Bourrier, Guillaume Le Gall, Valérie Lalande, Alexis De Rougemont and 13 more

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled TrialVideo-Audio Media
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Microbiome, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 232 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
232citing papers in PubMed, 11 pooled it
5.4field-weighted citation impact, top 3% 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.

NCT02097797 nacompletednot on this map

Impact of Fecal transPlantAtion on MiCrobotia and hosT in Crohn's Disease

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2014 to 2017Enrolled24ConditionsCrohn's DiseaseArmsFecal Transplantation, Sham Transplantation
NCT05611866 naunknown statusnot on this mapstarted 2022, after this paper: background citation

A Pilot Study of Fecal Microbiota Transplant (FMT) and Its Effects in Patients With Crohn's Disease With Moderate-to-High Risk of Colonization of Adherent-Invasive E. Coli (AIEC)

TypeinterventionalSponsorChinese University of Hong KongRan2022 to 2023Enrolled30ConditionsCrohn DiseaseArmsFecal Microbiota Transplantation
3 · Its place in the literature

Who cites it

232 citing papers in PubMed, 11 syntheses or guidelines pooled it, 356 citations in OpenAlex.

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172 more citing papers are in PubMed but not listed here.

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

23 authors at 5 institutions in 1 country.

Harry SokolCentre de Recherche Saint-Antoine, CRSA, AP-HP, Hôpital Saint Antoine, Service de Gastroenterologie, Sorbonne Université, Inserm, 75012, Paris, France. harry.sokol@aphp.fr.ORCID 0000-0002-2914-1822
Cecilia LandmanCentre de Recherche Saint-Antoine, CRSA, AP-HP, Hôpital Saint Antoine, Service de Gastroenterologie, Sorbonne Université, Inserm, 75012, Paris, France.
Philippe SeksikCentre de Recherche Saint-Antoine, CRSA, AP-HP, Hôpital Saint Antoine, Service de Gastroenterologie, Sorbonne Université, Inserm, 75012, Paris, France.
Laurence BerardClinical Research Platform (URC-CRC-CRB), AP-HP Saint-Antoine Hospital, Paris, France.
Mélissa MontilClinical Research Platform (URC-CRC-CRB), AP-HP Saint-Antoine Hospital, Paris, France.
Isabelle Nion-LarmurierDepartment of Gastroenterology, Saint Antoine Hospital, Assitance Publique-Hopitaux de Paris (APHP), 184 rue du Faubourg Saint-Antoine, 75571, Paris, CEDEX 12, France.
Anne BourrierDepartment of Gastroenterology, Saint Antoine Hospital, Assitance Publique-Hopitaux de Paris (APHP), 184 rue du Faubourg Saint-Antoine, 75571, Paris, CEDEX 12, France.
Guillaume Le GallDepartment of Gastroenterology, Saint Antoine Hospital, Assitance Publique-Hopitaux de Paris (APHP), 184 rue du Faubourg Saint-Antoine, 75571, Paris, CEDEX 12, France.
Valérie LalandeDepartment of Microbiology, Saint Antoine Hospital, Assitance Publique-Hopitaux de Paris (APHP), Paris, France.
Alexis De RougemontNational reference center for enteric virus, Virology laboratory, CHU de Dijon, France; UFR des Sciences de Santé, Université de Bourgogne, Dijon, France.
Julien KirchgesnerDepartment of Gastroenterology, Saint Antoine Hospital, Assitance Publique-Hopitaux de Paris (APHP), 184 rue du Faubourg Saint-Antoine, 75571, Paris, CEDEX 12, France.
Anne DaguenelDepartment of Pharmacy, Saint Antoine Hospital, Assitance Publique-Hopitaux de Paris (APHP), Paris, France.
Marine CachanadoClinical Research Platform (URC-CRC-CRB), AP-HP Saint-Antoine Hospital, Paris, France.
Alexandra RousseauClinical Research Platform (URC-CRC-CRB), AP-HP Saint-Antoine Hospital, Paris, France.
Élodie DrouetClinical Research Platform (URC-CRC-CRB), AP-HP Saint-Antoine Hospital, Paris, France.
Michelle RosenzwajgInflammation-Immunopathology-Biotherapy Department (DHU i2B), Paris, France.
Hervé HagegeDepartment of Gastroenterology, CHI Créteil, Créteil, France.
Xavier DrayDepartment of Hepato-Gastroenterology, APHP, Saint Antoine Hospital, Sorbonne University, Paris, France.
David KlatzmanInflammation-Immunopathology-Biotherapy Department (DHU i2B), Paris, France.
Philippe MarteauDepartment of Hepato-Gastroenterology, APHP, Saint Antoine Hospital, Sorbonne University, Paris, France.
Saint-Antoine IBD Network
Laurent BeaugerieDepartment of Gastroenterology, Saint Antoine Hospital, Assitance Publique-Hopitaux de Paris (APHP), 184 rue du Faubourg Saint-Antoine, 75571, Paris, CEDEX 12, France.
Tabassome SimonClinical Research Platform (URC-CRC-CRB), AP-HP Saint-Antoine Hospital, Paris, France.
Sorbonne Université · FRInserm · FRAssistance Publique – Hôpitaux de Paris · FRUniversité de Bourgogne · FRInstitut thématique Immunologie, inflammation, infectiologie et microbiologie · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodPatients 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).

resultsEight 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.

conclusionThe 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.

Indexed as

Fecal Microbiota TransplantationAdrenal Cortex HormonesAdultCrohn DiseaseFecesFemaleHumansMaleMicrobiotaPilot ProjectsRemission InductionResearch DesignSeverity of Illness IndexSingle-Blind MethodTreatment OutcomeAdrenal Cortex HormonesCrohn’s diseaseFecal microbiota transplantationRandomized controlled trial

Identifiers

PMID32014035
PMCPMC6998149
OpenAlexW3010294184

What OpenQuestion holds

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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.