TY - JOUR

T1 - Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome

T2 - results from a randomised, double-blind placebo-controlled study

AU - Halkjær, Sofie Ingdam

AU - Christensen, Alice Højer

AU - Lo, Bobby Zhao Sheng

AU - Browne, Patrick Denis

AU - Günther, Stig

AU - Hansen, Lars Hestbjerg

AU - Petersen, Andreas Munk

N1 - © Author(s) (or their employer(s)) 2018. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2018/12

Y1 - 2018/12

N2 - 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.

AB - 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.

KW - Adolescent

KW - Adult

KW - Double-Blind Method

KW - Fecal Microbiota Transplantation/adverse effects

KW - Feces/microbiology

KW - Female

KW - Gastrointestinal Microbiome

KW - Humans

KW - Irritable Bowel Syndrome/microbiology

KW - Male

KW - Middle Aged

KW - Psychometrics

KW - Quality of Life

KW - Severity of Illness Index

KW - Treatment Outcome

KW - Young Adult

KW - irritable bowel syndrome

KW - colonic microflora

U2 - 10.1136/gutjnl-2018-316434

DO - 10.1136/gutjnl-2018-316434

M3 - Journal article

C2 - 29980607

VL - 67

SP - 2107

EP - 2115

JO - Gut

JF - Gut

SN - 0017-5749

IS - 12

ER -