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Cited by 437Gastrointestinal motility and disordersGut microbiota and healthInflammatory Bowel Disease

The DOI matches its Crossref record; 26 of the 29 references it cites were found in a registry or an index.

Faecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomised, placebo-controlled, parallel-group, single-centre trial

Johnsen, Peter Holger, Hilpüsch, Frank, Cavanagh, Jorunn Pauline, Leikanger, Ingrid Sande, Kolstad, Caroline, Valle, Per Christian, Goll, Rasmus·2018·The Lancet Gastroenterology & Hepatology
DOI 10.1016/s2468-1253(17)30338-2
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Abstract

Background Irritable bowel syndrome (IBS) is a common condition characterised by abdominal pain, bloating, and poor quality of life. IBS might be caused by a gut dysbiosis. We aimed to compare faecal microbiota transplantation (FMT) with placebo in patients with IBS.Methods In this double-blind, randomised, placebo-controlled, parallel-group, single-centre study, we enrolled patients with IBS with diarrhoea or with diarrhoea and constipation (excluding dominating constipation) defined by the ROME III criteria, scored as moderate to severe according to the IBS severity scoring system (IBS-SSS; a score of ≥175). Eligible participants were aged 18-75 years and were recruited locally by general practitioners in northern Norway. We randomly assigned participants (2:1) in blocks of six to active or placebo FMT. Personnel not involved in the clinical performance of the trial generated the randomisation sequence using a randomisation website. Non-study personnel performed the final allocation and standardised the active and placebo transplants to make them identical in appearance and temperature. The faeces were freshly processed, and were used the same day (fresh transplant) or were stored in a freezer for later use (frozen transplant); participants' own faeces served as placebo. A dose of 8 mg loperamide was administered orally 2 h before endoscopy to retain the transplant. The transplant (50-80 g of faeces mixed with 200 mL of isotonic saline and 50 mL of 85% glycerol) was administered by a colonoscope to the caecum. The primary endpoint was symptom relief of more than 75 points assessed by IBS-SSS, 3 months after FMT. The primary analysis was done in the modified intention-to-treat population, excluding participants who did not undergo treatment or who were diagnosed with any other disease by pinch biopsies obtained during the treatment procedure. For the safety analysis, only participants who did not undergo treatment were excluded. The study is registered with ClinicalTrials.gov, number NCT02154867. The trial has been extended with an open-labelled study treating the placebo group with frozen FMT for further exploratory studies.Findings Between Jan 1, and Oct 30, 2015, we recruited 90 participants and randomly assigned them to active treatment (n=60) or placebo (n=30). Three participants did not undergo FMT and four were excluded after diagnosis of microscopic colitis, leaving 83 for final modified intention-to-treat analysis (55 in the active treatment group and 28 in the placebo group). 36 (65%) of 55 participants receiving active treatment versus 12 (43%) of 28 receiving the placebo showed response at 3 months (p=0·049). One participant had transient nausea and vertigo (active group) and was observed at the hospital for a few hours after the procedure. Two participants had soiling of transplant on their way home from treatment (one in each group) and three experienced self-limiting intermittent abdominal pain (one in the active group and two in the placebo group). No serious adverse events could be attributed to FMT.Interpretation FMT induced significant symptom relief in patients with IBS. However, larger multicentre studies are needed to confirm the results.Funding HelseNord and the Norwegian Centre of Rural Medicine, University of Tromsø.

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Research works printed but not linked: 2

  1. Chang, 2006, From Rome to Los Angeles–the Rome III criteria for the functional GI disorders, Gastroenterology, 130, 1480
  2. Triantafyllou, 2002, Problems and challenges in the design of irritable bowel syndrome clinical trials. Focusing on the future with the experience from the past, Ann Gastroenterol, 15, 263

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Metadata

Authors
Johnsen, P. H., Hilpüsch, F., Cavanagh, J. P., Leikanger, I. S., Kolstad, C., Valle, P. C., & Goll, R.
Affiliations
  • University Hospital of North Norway (NO)
  • UiT The Arctic University of Norway (NO)
Corresponding author
Johnsen, Peter Holger
ORCID
Venue
The Lancet Gastroenterology & Hepatology
Publisher
Elsevier BV
Published
2018-01
Volume
3
Issue
1
Pages
17-24
ISSN
  • 2468-1156 (ISSN-L)
  • 2468-1253
DOI
10.1016/s2468-1253(17)30338-2
OpenAlex
W2766752206
Cited by
437
References
29
Citations by year
2026: 22 · 2025: 30 · 2024: 48 · 2023: 46 · 2022: 59 · 2021: 52 · 2020: 68 · 2019: 70 · 2018: 39
FWCI
51.26
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • The Lancet. Gastroenterology & hepatology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
  • Health Sciences › Medicine › Gastroenterology › Inflammatory Bowel Disease
Keywords
fecal microbiota transplantation, irritable bowel syndrome, irritable bowel syndrome with constipation, gut dysbiosis, IBS symptom severity, symptom relief, loperamide, Rome III criteria, IBS-SSS, treatment safety, open-label extension
MeSH terms
Fecal Microbiota Transplantation, Proof of Concept Study, Adult, Double-Blind Method, Female, Humans, Male, Middle Aged, Nausea, Vertigo, Abdominal Pain, Irritable Bowel Syndrome

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