Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study.

Sofie Ingdam Halkjær, Alice Højer Christensen, Bobby Zhao Sheng Lo, Patrick Denis Browne, Stig Günther, Lars Hestbjerg Hansen, Andreas Munk Petersen

Journal: Gut 2018;67(12):2107-2115

PMID: 29980607

Plain Language Summary

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Irritable bowel syndrome (IBS) is a common gastrointestinal (GI) disorder of unknown cause. It is thought that the bacterial composition of the GI tract (microbiota) plays an important role in IBS. Faecal microbiota transplantation (FMT) has been shown to create lasting changes in the bacterial composition of the recipient’s GI tract in a number of conditions. The aim of this randomised, double-blind placebo-controlled study was to evaluate the effects of FMT on symptoms and gut microbiota in patients with IBS. 52 IBS patients received either orally administered FMT or placebo, following pre-treatment in the form of a bowel cleanse. IBS severity scores and quality of life were assessed and faecal samples obtained at baseline, and 1, 3 and 6 months after treatment. Quality of life and IBS severity scores improved in both groups, but significantly more so in the placebo group. The healthy faecal donors had higher microbial biodiversity (a sign of a healthy microbial composition) than patients with IBS prior to treatment. Patients in the FMT group had an increase in biodiversity to the extent that this group was not statistically different from the healthy donors any more, whilst no significant changes in the microbiota were observed in the placebo group. The authors conclude that more studies are required to examine the potential role of FMT in treating IBS, evaluating different factors such as route of administration, pre-treatment, duration of treatment and dose.

Abstract

OBJECTIVE

IBS is associated with an intestinal dysbiosis and faecal microbiota transplantation (FMT) has been hypothesised to have a positive effect in patients with IBS. We performed a randomised, double-blind placebo-controlled trial to investigate if FMT resulted in an altered gut microbiota and improvement in clinical outcome in patients with IBS.

DESIGN

We performed this study in 52 adult patients with moderate-to-severe IBS. At the screening visit, clinical history and symptoms were assessed and faecal samples were collected. Patients were randomised to FMT or placebo capsules for 12 days and followed for 6 months. Study visits were performed at baseline, 1, 3 and 6 months, where patients were asked to register their symptoms using the IBS-severity scoring system (IBS-SSS) and IBS-specific quality of life (IBS-QoL). Prior to each visit, faecal samples were collected.

RESULTS

A significant difference in improvement in IBS-SSS score was observed 3 months after treatment (p=0.012) favouring placebo. This was similar for IBS-QoL data after 3 months (p=0.003) favouring placebo. Patients receiving FMT capsules had an increase in faecal microbial biodiversity while placebos did not.

CONCLUSION

In this randomised double-blinded placebo-controlled study, we found that FMT changed gut microbiota in patients with IBS. But patients in the placebo group experienced greater symptom relief compared with the FMT group after 3 months. Altering the gut microbiota is not enough to obtain clinical improvement in IBS. However, different study designs and larger studies are required to examine the role of FMT in IBS.

TRIAL REGISTRATION NUMBER

NCT02788071.

© Author(s) (or their employer(s)) 2018. No commercial re-use. See rights and permissions. Published by BMJ.

Address: Department of Gastroenterology, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark.; Department of Gastroenterology, Aleris-Hamlet Hospitals Copenhagen, Soborg, Denmark.; Department of Environmental Science, Aarhus University, Roskilde, Denmark.

Patient Centred Factor

Physical Environment

Clinical Imbalances

Laboratory Testing

Jadad Score

Allocation Concealment

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