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Cited by 498Gastrointestinal motility and disordersGut microbiota and healthInflammatory Bowel Disease

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

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El-Salhy, Magdy, Hatlebakk, Jan Gunnar, Gilja, Odd Helge, Bråthen Kristoffersen, Anja, Hausken, Trygve·2020·Gut
DOI 10.1136/gutjnl-2019-319630PMC PMC7229896
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Abstract

OBJECTIVE: Faecal 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. DESIGN: This 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. RESULTS: Responses 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. CONCLUSIONS: www.clinicaltrials.gov (NCT03822299) and www.cristin.no (ID657402).

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  • More than 50% of patients in this trial continued to have moderate to severe symptoms.

    “However, more than 50% of patients in this trial continued to have moderate to severe symptoms”

    From Irritable bowel syndrome (2020) · cites this paper as [137]

    Methods (Enrolment and randomisation of patients; page unavailable) defines moderate-to-severe symptoms as an IBS-SSS score of at least 175 at enrolment. Results (Abdominal symptoms, fatigue and quality of life; page unavailable) reports follow-up mean scores and percentages with clinically significant improvement, but not the percentage of patients who still scored at least 175. Those results do not establish that more than 50% continued to have moderate-to-severe symptoms. (LLM, conf=0.78)

    Experimental — accuracy not yet measured

  • A RCT of faecal microbiota transplantation using a single, healthy, well-characterised donor demonstrated efficacy.

    “although a RCT of faecal microbiota transplantation using a single, healthy, well-characterised donor demonstrated efficacy”

    From Irritable bowel syndrome (2020) · cites this paper as [137]

  • The amount of infused feces may influence the clinical effectiveness of FMT.

    “There is also evidence that also the amount of infused feces could influence the clinical effectiveness of FMT.”

    From Key determinants of success in fecal microbiota transplantation: From microbiome to clinic (2023) · cites this paper as [65]

  • The relationship between high quantities of feces and clinical success has been confirmed in disorders beyond CDI.

    “The relationship between high quantities of feces and clinical success has also been confirmed in disorders beyond CDI.”

    From Key determinants of success in fecal microbiota transplantation: From microbiome to clinic (2023) · cites this paper as [65]

  • In IBS patients, increasing infused feces from 30 to 60 g increased FMT success rate from 76.9% to 89.1%.

    “In a randomized controlled trial of FMT in IBS patients, increasing infused feces from 30 to 60 g increased the success rate from 76.9% to 89.1%.”

    From Key determinants of success in fecal microbiota transplantation: From microbiome to clinic (2023) · cites this paper as [65]

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Authors
El-Salhy, M., Hatlebakk, J. G., Gilja, O. H., Bråthen Kristoffersen, A., & Hausken, T.
Affiliations
  • Stord Hospital, Stord, Norway
  • University of Bergen (NO)
  • Genetic Analysis As, Oslo, Norway
ORCID
Venue
Gut
Publisher
BMJ
Published
2019-12-18
Volume
69
Issue
5
Pages
859-867
ISSN
  • 0017-5749 (ISSN-L)
  • 1468-3288
DOI
10.1136/gutjnl-2019-319630
PMC
PMC7229896
OpenAlex
W2996060321
Cited by
498
References
41
Citations by year
2026: 48 · 2025: 62 · 2024: 80 · 2023: 82 · 2022: 100 · 2021: 67 · 2020: 58 · 2019: 1
FWCI
51.28
Type
journal article
Language
en
Open access
Licence
Locations
  • Gut (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • NORA - Norwegian Open Research Archives (submittedVersion, cc-by-nc)
  • HighWire Press Open Archive (submittedVersion)
Funders
  • Helse Fonna (40415)
  • Helse Vest (912234)
Topics
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
Keywords
fecal microbiota transplantation, irritable bowel syndrome, dysbiosis index, 16S rRNA gene sequencing, fatigue, quality of life, adverse events
MeSH terms
Gastrointestinal Microbiome, Fecal Microbiota Transplantation, Adult, Double-Blind Method, Female, Humans, Male, Middle Aged, Prognosis, Reference Values, Severity of Illness Index, Treatment Outcome, Patient Satisfaction, Risk Assessment, Recovery of Function, Irritable Bowel Syndrome, Donor Selection

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