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 - 2018/12/1
Y1 - 2018/12/1
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
SN - 0017-5749
VL - 67
SP - 2107
EP - 2115
JO - Gut
JF - Gut
IS - 12
ER -