PMID- 33785557 OWN - NLM STAT- MEDLINE DCOM- 20220509 LR - 20220509 IS - 1468-3288 (Electronic) IS - 0017-5749 (Linking) VI - 71 IP - 4 DP - 2022 Apr TI - Microbiota engraftment after faecal microbiota transplantation in obese subjects with type 2 diabetes: a 24-week, double-blind, randomised controlled trial. PG - 716-723 LID - 10.1136/gutjnl-2020-323617 [doi] AB - OBJECTIVE: The impact of faecal microbiota transplantation (FMT) on microbiota engraftment in patients with metabolic syndrome is uncertain. We aimed to study whether combining FMT with lifestyle modification could enhance the engraftment of favourable microbiota in obese patients with type 2 diabetes mellitus (T2DM). DESIGN: In this double-blind, randomised, placebo-controlled trial, 61 obese subjects with T2DM were randomly assigned to three parallel groups: FMT plus lifestyle intervention (LSI), FMT alone, or sham transplantation plus LSI every 4 weeks for up to week 12. FMT solution was prepared from six healthy lean donors. Faecal metagenomic sequencing was performed at baseline, weeks 4, 16 and 24. The primary outcome was the proportion of subjects acquiring >/=20% of microbiota from lean donors at week 24. RESULTS: Proportions of subjects acquiring >/=20% of lean-associated microbiota at week 24 were 100%, 88.2% and 22% in the FMT plus LSI, FMT alone, and sham plus LSI groups, respectively (p<0.0001). Repeated FMTs significantly increased the engraftment of lean-associated microbiota (p<0.05). FMT with or without LSI increased butyrate-producing bacteria. Combining LSI and FMT led to increase in Bifidobacterium and Lactobacillus compared with FMT alone (p<0.05). FMT plus LSI group had reduced total and low-density lipoprotein cholesterol and liver stiffness at week 24 compared with baseline (p<0.05). CONCLUSION: Repeated FMTs enhance the level and duration of microbiota engraftment in obese patients with T2DM. Combining lifestyle intervention with FMT led to more favourable changes in recipients' microbiota and improvement in lipid profile and liver stiffness. TRIAL REGISTRATION NUMBER: NCT03127696. CI - (c) Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Ng, Siew C AU - Ng SC AUID- ORCID: 0000-0002-6850-4454 AD - Center for Gut Microbiota Research, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China. AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. AD - State Key Laboratory of Digestive Disease, LKS Institute of Health Science, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China. AD - Microbiota Innovation Centre (MagIC Centre), Hong Kong, China. FAU - Xu, Zhilu AU - Xu Z AUID- ORCID: 0000-0002-5552-7534 AD - Center for Gut Microbiota Research, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China. AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. AD - State Key Laboratory of Digestive Disease, LKS Institute of Health Science, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China. AD - Microbiota Innovation Centre (MagIC Centre), Hong Kong, China. FAU - Mak, Joyce Wing Yan AU - Mak JWY AUID- ORCID: 0000-0001-5221-7349 AD - Center for Gut Microbiota Research, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China. AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. AD - State Key Laboratory of Digestive Disease, LKS Institute of Health Science, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China. FAU - Yang, Keli AU - Yang K AD - Center for Gut Microbiota Research, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China. AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. AD - State Key Laboratory of Digestive Disease, LKS Institute of Health Science, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China. FAU - Liu, Qin AU - Liu Q AD - Center for Gut Microbiota Research, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China. AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. AD - State Key Laboratory of Digestive Disease, LKS Institute of Health Science, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China. AD - Microbiota Innovation Centre (MagIC Centre), Hong Kong, China. FAU - Zuo, Tao AU - Zuo T AUID- ORCID: 0000-0001-8450-5281 AD - Center for Gut Microbiota Research, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China. AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. AD - State Key Laboratory of Digestive Disease, LKS Institute of Health Science, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China. AD - Microbiota Innovation Centre (MagIC Centre), Hong Kong, China. FAU - Tang, Whitney AU - Tang W AD - Center for Gut Microbiota Research, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China. AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. AD - State Key Laboratory of Digestive Disease, LKS Institute of Health Science, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China. AD - Microbiota Innovation Centre (MagIC Centre), Hong Kong, China. FAU - Lau, Louis AU - Lau L AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. FAU - Lui, Rashid N AU - Lui RN AUID- ORCID: 0000-0003-1277-9595 AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. FAU - Wong, Sunny H AU - Wong SH AUID- ORCID: 0000-0002-3354-9310 AD - Center for Gut Microbiota Research, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China. AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. AD - State Key Laboratory of Digestive Disease, LKS Institute of Health Science, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China. FAU - Tse, Yee Kit AU - Tse YK AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. FAU - Li, Amy Y L AU - Li AYL AD - Center for Gut Microbiota Research, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China. AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. AD - State Key Laboratory of Digestive Disease, LKS Institute of Health Science, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China. FAU - Cheung, Kitty AU - Cheung K AD - Center for Gut Microbiota Research, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China. AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. FAU - Ching, Jessica Y L AU - Ching JYL AD - Center for Gut Microbiota Research, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China. AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. FAU - Wong, Vincent W S AU - Wong VWS AUID- ORCID: 0000-0003-2215-9410 AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. AD - State Key Laboratory of Digestive Disease, LKS Institute of Health Science, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China. FAU - Kong, Alice P S AU - Kong APS AD - Division of Endocrinology and Diabetes, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. FAU - Ma, Ronald C W AU - Ma RCW AD - Division of Endocrinology and Diabetes, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. FAU - Chow, Elaine Y K AU - Chow EYK AUID- ORCID: 0000-0002-4147-3387 AD - Division of Endocrinology and Diabetes, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. AD - Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong, Hong Kong, China. FAU - Wong, Simon K H AU - Wong SKH AD - Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China. FAU - Ho, Ivan Chak Hang AU - Ho ICH AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. FAU - Chan, Paul K S AU - Chan PKS AD - Center for Gut Microbiota Research, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China. AD - Department of Microbiology, The Chinese University of Hong Kong, Hong Kong, China. FAU - Chan, Francis K L AU - Chan FKL AUID- ORCID: 0000-0001-7388-2436 AD - Center for Gut Microbiota Research, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China fklchan@cuhk.edu.hk. AD - Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China. AD - State Key Laboratory of Digestive Disease, LKS Institute of Health Science, Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China. AD - Microbiota Innovation Centre (MagIC Centre), Hong Kong, China. LA - eng SI - ClinicalTrials.gov/NCT03127696 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20210330 PL - England TA - Gut JT - Gut JID - 2985108R SB - IM MH - *Diabetes Mellitus, Type 2/complications/therapy MH - Double-Blind Method MH - Fecal Microbiota Transplantation MH - Feces MH - *Gastrointestinal Microbiome MH - Humans MH - Obesity/complications/microbiology/therapy MH - Treatment Outcome OTO - NOTNLM OT - enteric bacterial microflora OT - lipoprotein-cholesterol OT - obesity COIS- Competing interests: SCN has served as advisory board member for Pfizer, Ferring, Janssen, Abbvie and speaker for Ferring, Tillotts, Menarini, Janssen, Abbvie and Takeda. She has received research grants from Olympus, Ferring and Abbvie. FKLC has served as advisor and Lecture Speaker for Eisai Co. Ltd, AstraZeneca, Pfizer Inc, Takeda Pharmaceutical Co and Takeda (China) Holdings Co. Ltd. VW-SW has served as a consultant or advisory board member for 3V-BIO, AbbVie, Allergan, Boehringer Ingelheim, Center for Outcomes Research in Liver Diseases, Echosens, Gilead Sciences, Hanmi Pharmaceutical, Intercept, Merck, Novartis, Novo Nordisk, Perspectum Diagnostics, Pfizer, ProSciento, Sagimet Biosciences, TARGET PharmaSolutions and Terns; and a speaker for AbbVie, Bristol-Myers Squibb, Echosens and Gilead Sciences. He has received a grant from Gilead Sciences for fatty liver research. ZX: none to declare. JWYM: none to declare. KY: none to declare. QL: none to declare. TZ: none to declare. WT: none to declare. LL: none to declare. RNL: none to declare. SW: none to declare. YKT: none to declare. AYLL: none to declare. KC: none to declare. JYLC: none to declare. AP-SK: none to declare. RM: none to declare. EC: none to declare. SKHW: none to declare. CHH: none to declare. PC: none to declare. EDAT- 2021/04/01 06:00 MHDA- 2022/05/10 06:00 CRDT- 2021/03/31 06:08 PHST- 2020/11/15 00:00 [received] PHST- 2021/03/04 00:00 [revised] PHST- 2021/03/08 00:00 [accepted] PHST- 2021/04/01 06:00 [pubmed] PHST- 2022/05/10 06:00 [medline] PHST- 2021/03/31 06:08 [entrez] AID - gutjnl-2020-323617 [pii] AID - 10.1136/gutjnl-2020-323617 [doi] PST - ppublish SO - Gut. 2022 Apr;71(4):716-723. doi: 10.1136/gutjnl-2020-323617. Epub 2021 Mar 30.