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Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study
  1. Magdy El-Salhy1,2,
  2. Jan Gunnar Hatlebakk2,
  3. Odd Helge Gilja2,
  4. Anja Bråthen Kristoffersen3,
  5. Trygve Hausken2
  1. 1 Stord Hospital, Stord, Norway
  2. 2 Department of Clinical Medicine, University of Bergen Faculty of Medicine and Dentistry, Bergen, Norway
  3. 3 Genetic Analysis As, Oslo, Norway
  1. Correspondence to Professor Magdy El-Salhy, Stord Hospital, Stord, Norway; magdy.elsalhy{at}sklbb.no

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 FMT 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.

Trial registration

www.clinicaltrials.gov (NCT03822299) and www.cristin.no (ID657402).

  • lactobacillus
  • irritable bowel syndrome
  • colonic microflora

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Footnotes

  • Presented at This study was previously presented as an abstract at UEG Week 2019 and at ESNM meeting 2019.

  • Contributors MES designed the study, obtained the funding, administrated the study, recruited the patients, performed FMT, collected, analysed, and interpreted the data and drafted the manuscript, ABK analysed the bacterial profiles using PCA and critically revised of the manuscript for important intellectual content. OHG, JGH and TH contributed to the design of the study, to the analysis and interpretation of the data, and critically revised of the manuscript for important intellectual content.

  • Funding The study was supported by grants from Helse Fonna (grant no. 40415) and Helse Vest (grant no. 192234).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval The study was performed in accordance with the Declaration of Helsinki and was approved by the Regional Committee for Medical and Health Research Ethics West, Bergen, Norway (2017/1197/REK vest).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request. Data are stored at Helse Vest server and anonymous data are available upon reasonable request.

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