Evidence map›Paper›PMID 31852769›Full record

Trial reportGut2020

Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study.

Magdy El-Salhy, Jan Gunnar Hatlebakk, Odd Helge Gilja, Anja Bråthen Kristoffersen, Trygve Hausken

6 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gut, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 255 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
255citing papers in PubMed, 19 pooled it
36.6field-weighted citation impact, top 1% 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.

NCT04706611 narecruitingnot on this mapstarted 2021, after this paper: background citation

Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Intestinal Dysbiosis -A Pilot Study

TypeinterventionalSponsorGuangzhou First People's HospitalRan2021 to 2026Enrolled300ConditionsFecal Microbiota TransplantationArmsFecal Microbiota Transplantation
NCT05864716 naunknown statusnot on this mapstarted 2024, after this paper: background citation

The Comparison of the Effect of Probiotics Between Delivery Via Colonoscopic Spray and Oral Administration in the Treatment of Irritable Bowel Syndrome

TypeinterventionalSponsorNational Cheng-Kung University HospitalRan2024 to 2026Enrolled66ConditionsEffect of DrugArmsColonscopic probiotics spray
NCT06201182 naunknown statusnot on this map

Efficacy of Fecal Microbiota Transplantation (FMT) in Irritable Bowel Syndrome (IBS): A Randomized, Placebo-controlled, Double-blind Study

TypeinterventionalSponsorThammasat UniversityRan2020 to 2024Enrolled45ConditionsIrritable Bowel SyndromeArmsFMT via rectal enema, FMT capsules, Placebo via rectal enema, Placebo capsules
NCT06697119 naactive not recruitingnot on this mapstarted 2023, after this paper: background citation

Efficacy and Safety of Fecal Microbiota Transplantation in Patients with Irritable Bowel Syndrome

TypeinterventionalSponsorSeoul National University HospitalRan2023 to 2027Enrolled44ConditionsIrritable Bowel DiseaseArmsFecal Microbial Transplantation
NCT06845527 recruitingnot on this mapstarted 2025, after this paper: background citation

Characteristics and Outcomes of Outpatients Referred to an Gut Microbiota Clinic

Typeobservational_patient_registrySponsorFondazione Policlinico Universitario Agostino Gemelli IRCCSRan2025 to 2027Enrolled400ConditionsIntestinal DiseaseArmsMicrobiome testing and Cytokine profiling
NCT06992453 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Disentangling Microbiome Engraftment by Multi-omics of the Gut Ecosystem During Fecal Transplant

TypeinterventionalSponsorCatholic University of the Sacred HeartRan2026 to 2029Enrolled90ConditionsRecurrent C. Difficile (rCDI), Ulcerative Colitis (UC), Metabolic Syndrome (MetS)ArmsFecal microbiota transplantation (FMT)
3 · Its place in the literature

Who cites it

255 citing papers in PubMed, 19 syntheses or guidelines pooled it, 467 citations in OpenAlex.

  1. Altered molecular signature of the intestinal microbiota in irritable bowel syndrome patients versus healthy controls: An updated systematic review.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2026
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195 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Magdy El-SalhyStord Hospital, Stord, Norway magdy.elsalhy@sklbb.no.ORCID 0000-0003-3398-3288
Jan Gunnar HatlebakkDepartment of Clinical Medicine, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway.
Odd Helge GiljaDepartment of Clinical Medicine, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway.
Anja Bråthen KristoffersenGenetic Analysis As, Oslo, Norway.
Trygve HauskenDepartment of Clinical Medicine, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway.
University of Bergen · NOGenetic Analysis (Norway) · NOStord hospital · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveFaecal microbiota transplantation (FMT) from healthy donors to patients with irritable bowel syndrome (IBS) has been attempted in two previous double-blind, placebo-controlled studies. While one of those studies found improvement of the IBS symptoms, the other found no effect. The present study was conducted to clarify these contradictory findings.

designThis randomised, double-blind, placebo-controlled study randomised 165 patients with IBS to placebo (own faeces), 30 g FMT or 60 g FMT at a ratio of 1:1:1. The material for FMT was obtained from one healthy, well-characterised donor, frozen and administered via gastroscope. The primary outcome was a reduction in the IBS symptoms at 3 months after FMT (response). A response was defined as a decrease of 50 or more points in the total IBS symptom score. The secondary outcome was a reduction in the dysbiosis index (DI) and a change in the intestinal bacterial profile, analysed by 16S rRNA gene sequencing, at 1 month following FMT.

resultsResponses occurred in 23.6%, 76.9% (p<0.0001) and 89.1% (p<00.0001) of the patients who received placebo, 30 g FMT and 60 g FMT, respectively. These were accompanied by significant improvements in fatigue and the quality of life in patients who received FMT. The intestinal bacterial profiles changed also significantly in the groups received FMT. The FMT adverse events were mild self-limiting gastrointestinal symptoms.

conclusionsFMT is an effective treatment for patients with IBS. Utilising a well-defined donor with a normal DI and favourable specific microbial signature is essential for successful FMT. The response to FMT increases with the dose.

Indexed as

AdultDonor SelectionDouble-Blind MethodFecal Microbiota TransplantationFemaleGastrointestinal MicrobiomeHumansIrritable Bowel SyndromeMaleMiddle AgedPatient SatisfactionPrognosisRecovery of FunctionReference ValuesRisk AssessmentSeverity of Illness Indexcolonic microflorairritable bowel syndromelactobacillus

Identifiers

PMID31852769
PMCPMC7229896
OpenAlexW2996060321

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.