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.
- irritable bowel syndrome
- colonic microflora
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Contributors SIH, SG, AHC, LHH and AMP designed the research project; SG designed and produced the capsules, SIH and AHC performed the clinical research; BZSL performed the statistical analysis, LHH and PDB performed the sequencing and microbiota analysis, SIH, BZSL and PDB wrote the paper; AHC and AMP supervised the paper; all authors read, commented and approved the final manuscript.
Funding The study is financed by grants from the private foundations: Wedell-Wedellsborgs Fund, Toyota-Fonden Denmark, Danish Colitis-Crohn’s Associations Research Fund, Tømmerhandler Johannes Fogs Fond, Villy Safft Nielsens Fond, Villum Foundation Block Stipend, MicroHealth (Innovation Fund Denmark) and co-financed by Aleris-Hamlet Research and Development Fund and Department of Gastroenterology Hvidovre University Hospital.
Disclaimer The funding sources had no role in the study design, data collection, interpretation of analysis, writing of the manuscript or decision to submit the publication.
Competing interests None declared.
Patient consent Obtained.
Ethics approval This study was approved by the Ethical Committee, Denmark (protocol number: H-15016343).
Provenance and peer review Not commissioned; externally peer reviewed.
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