El-Salhy M, Hatlebakk JG, Gilja OH, et al. Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study. Gut. 2019 Dec 18. pii: gutjnl-2019-319630. doi: 10.1136/gutjnl-2019-319630.
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).

Ratings by Clinicians (at least 3 per Specialty)
Specialty Score
Family Medicine (FM)/General Practice (GP)
General Internal Medicine-Primary Care(US)
Internal Medicine
Gastroenterology
Comments from MORE raters

Gastroenterology rater

Significant treatment effect, although there is much more to learn about IBS subtypes that might be more or less responsive and also proper donor selection.

Gastroenterology rater

Very interesting study. I would like to see a larger number of patients in each subtype of IBS.

Gastroenterology rater

Relevant article but needs more discussion on indications for EGD administration of frozen stool vs sigmoid/colonoscopy administration. Frozen samples may be less effective and may be associated with higher relapse.

Gastroenterology rater

This is a rigorous randomised, double-blind, placebo-controlled study that showed a dose-dependent response of fecal microbiota transplantation (FMT) in patients with irritable bowel syndrome (IBS). The only drawback is that it is a single-center study. Also, FMT is currently not approved by the Food and Drug Administration for management of IBS, so its use is still limited to clinical research study settings. Nonetheless, these findings are significant and can potentially impact the way IBS is managed in the field of gastroenterology.

General Internal Medicine-Primary Care(US) rater

This is a small study and it is early days for fecal transplants. We`re not yet sure exactly what the fecal transplant is doing, and there are safety concerns. Still, this is a well-done study for a condition that is difficult to treat.

General Internal Medicine-Primary Care(US) rater

FMT is being used more widely with little evidence to support it. This is an excellent study evaluating its use in IBS and provides good evidence regarding efficacy.

Internal Medicine rater

Really interesting result.

Internal Medicine rater

Well designed RCT.