Microbiota engraftment after faecal microbiota transplantation in obese subjects with type 2 diabetes: a 24-week, double-blind, randomised controlled trial
ObjectiveThe 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...
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| Published in | Gut Vol. 71; no. 4; pp. 716 - 723 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
BMJ Publishing Group Ltd and British Society of Gastroenterology
01.04.2022
BMJ Publishing Group LTD |
| Subjects | |
| Online Access | Get full text |
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| Abstract | ObjectiveThe 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).DesignIn 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.ResultsProportions 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).ConclusionRepeated 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. |
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| AbstractList | 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).OBJECTIVEThe 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).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.DESIGNIn 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.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).RESULTSProportions 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).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.CONCLUSIONRepeated 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.NCT03127696.TRIAL REGISTRATION NUMBERNCT03127696. ObjectiveThe 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).DesignIn 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.ResultsProportions 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).ConclusionRepeated 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 numberNCT03127696. 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). 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. 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 and 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). 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. NCT03127696. ObjectiveThe 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).DesignIn 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.ResultsProportions 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).ConclusionRepeated 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. |
| Author | Mak, Joyce Wing Yan Liu, Qin Ching, Jessica Y L Chan, Francis K L Kong, Alice P S Ng, Siew C Chan, Paul K S Wong, Vincent W S Chow, Elaine Y K Wong, Sunny H Ma, Ronald C W Xu, Zhilu Zuo, Tao Tang, Whitney Lui, Rashid N Ho, Ivan Chak Hang Cheung, Kitty Yang, Keli Li, Amy Y L Lau, Louis Wong, Simon K H Tse, Yee Kit |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33785557$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ. Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ. 2022 Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ. |
| Copyright_xml | – notice: Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ. – notice: Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ. – notice: 2022 Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ. |
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| DOI | 10.1136/gutjnl-2020-323617 |
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| Issue | 4 |
| Keywords | lipoprotein-cholesterol enteric bacterial microflora obesity |
| Language | English |
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syndrome publication-title: Gastroenterology doi: 10.1053/j.gastro.2012.06.031 – volume: 12 year: 2011 article-title: Metagenomic biomarker discovery and explanation publication-title: Genome Biol doi: 10.1186/gb-2011-12-6-r60 – volume: 160 start-page: 158 year: 2021 article-title: Effects of diet-modulated autologous fecal microbiota transplantation on weight regain publication-title: Gastroenterology doi: 10.1053/j.gastro.2020.08.041 – volume: 24 start-page: 1526 year: 2018 article-title: Depicting the composition of gut microbiota in a population with varied ethnic origins but shared geography publication-title: Nat Med doi: 10.1038/s41591-018-0160-1 – volume: 26 start-page: 611 year: 2017 article-title: Improvement of insulin sensitivity after lean donor feces in metabolic syndrome is driven by baseline intestinal microbiota composition publication-title: Cell Metab doi: 10.1016/j.cmet.2017.09.008 – volume: 9 year: 2018 article-title: High throughput in situ metagenomic measurement of bacterial replication at ultra-low sequencing coverage publication-title: Nat Commun doi: 10.1038/s41467-018-07240-8 – volume: 490 start-page: 55 year: 2012 article-title: A metagenome-wide association study of gut microbiota in type 2 diabetes publication-title: Nature doi: 10.1038/nature11450 – volume: 352 start-page: 586 year: 2016 article-title: Durable coexistence of donor and recipient strains after fecal microbiota transplantation publication-title: Science doi: 10.1126/science.aad8852 – volume: 6 start-page: 1769 year: 2013 article-title: A novel integrated method for large-scale detection, identification, and quantification of widely targeted metabolites: application in the study of rice metabolomics publication-title: Mol Plant doi: 10.1093/mp/sst080 – volume: 30 start-page: 2114 year: 2014 article-title: Trimmomatic: a flexible trimmer for illumina sequence data publication-title: Bioinformatics doi: 10.1093/bioinformatics/btu170 – volume: 500 start-page: 541 year: 2013 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tissue via the gut-brain neural circuit publication-title: Gut doi: 10.1136/gutjnl-2017-314050 – volume: 102 start-page: 11070 year: 2005 article-title: Obesity alters gut microbial ecology publication-title: Proc Natl Acad Sci U S A doi: 10.1073/pnas.0504978102 – volume: 17 year: 2020 article-title: Fecal microbiota transplantation for the improvement of metabolism in obesity: the FMT-TRIM double-blind placebo-controlled pilot trial publication-title: PLoS Med doi: 10.1530/ey.17.14.15 – volume: 363 start-page: 157 year: 2004 article-title: Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies publication-title: Lancet doi: 10.1016/S0140-6736(03)15268-3 – volume: 11 start-page: 577 year: 2015 article-title: Short-chain fatty acids in control of body weight and insulin sensitivity publication-title: Nat Rev Endocrinol doi: 10.1038/nrendo.2015.128 – volume: 70 start-page: 92 year: 2021 article-title: Faecal microbiota transplantation halts progression of human new-onset type 1 diabetes in a randomised controlled trial publication-title: Gut doi: 10.1136/gutjnl-2020-322630 – volume: 10 start-page: 313 year: 2009 article-title: Long-term effectiveness of diet-plus-exercise interventions vs. diet-only interventions for weight loss: a meta-analysis publication-title: Obes Rev doi: 10.1111/j.1467-789X.2008.00547.x – volume: 4 year: 2019 article-title: Welcome to the Tidyverse publication-title: J Open Source Softw doi: 10.21105/joss.01686 – start-page: 235 year: 2012 article-title: Phyloseq: a Bioconductor package for handling and analysis of high-throughput phylogenetic sequence data publication-title: Pac Symp Biocomput – volume: 341 year: 2013 article-title: Gut microbiota from twins discordant for obesity modulate metabolism in mice publication-title: Science doi: 10.1126/science.1241214 – volume: 23 start-page: 458 year: 2018 article-title: Small intestine microbiota regulate host digestive and absorptive adaptive responses to dietary lipids publication-title: Cell Host Microbe doi: 10.1016/j.chom.2018.03.011 – volume: 9 year: 2018 ident: 2022060711565756000_71.4.716.21 article-title: High throughput in situ metagenomic measurement of bacterial replication at ultra-low sequencing coverage publication-title: Nat Commun doi: 10.1038/s41467-018-07240-8 – ident: 2022060711565756000_71.4.716.14 doi: 10.1016/S0140-6736(03)15268-3 – ident: 2022060711565756000_71.4.716.4 doi: 10.1038/nature05414 – ident: 2022060711565756000_71.4.716.30 doi: 10.1136/gutjnl-2017-314050 – ident: 2022060711565756000_71.4.716.7 doi: 10.1053/j.gastro.2012.06.031 – ident: 2022060711565756000_71.4.716.8 doi: 10.1016/j.cmet.2017.09.008 – volume: 28 start-page: 245 year: 2020 ident: 2022060711565756000_71.4.716.28 article-title: Cholesterol metabolism by uncultured human gut bacteria influences host cholesterol level publication-title: Cell Host Microbe doi: 10.1016/j.chom.2020.05.013 – volume: 389 start-page: 1218 year: 2017 ident: 2022060711565756000_71.4.716.25 article-title: Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial publication-title: The Lancet doi: 10.1016/S0140-6736(17)30182-4 – volume: 24 start-page: 1526 year: 2018 ident: 2022060711565756000_71.4.716.31 article-title: Depicting the composition of gut microbiota in a population with varied ethnic origins but shared geography publication-title: Nat Med doi: 10.1038/s41591-018-0160-1 – ident: 2022060711565756000_71.4.716.11 doi: 10.1136/gutjnl-2020-322630 – ident: 2022060711565756000_71.4.716.5 doi: 10.1038/nature11450 – volume: 115 start-page: 1055 year: 2020 ident: 2022060711565756000_71.4.716.29 article-title: Allogenic fecal microbiota transplantation in patients with nonalcoholic fatty liver disease improves abnormal small intestinal permeability: a randomized control trial publication-title: Am J Gastroenterol doi: 10.14309/ajg.0000000000000661 – ident: 2022060711565756000_71.4.716.17 doi: 10.1038/s41592-018-0176-y – volume: 160 start-page: 158 year: 2021 ident: 2022060711565756000_71.4.716.13 article-title: Effects of diet-modulated autologous fecal microbiota transplantation on weight regain publication-title: Gastroenterology doi: 10.1053/j.gastro.2020.08.041 – ident: 2022060711565756000_71.4.716.16 doi: 10.1038/nmeth.3589 – ident: 2022060711565756000_71.4.716.1 doi: 10.1111/j.1467-789X.2008.00547.x – volume: 17 year: 2020 ident: 2022060711565756000_71.4.716.9 article-title: Fecal microbiota transplantation for the improvement of metabolism in obesity: the FMT-TRIM double-blind placebo-controlled pilot trial publication-title: PLoS Med doi: 10.1371/journal.pmed.1003051 – start-page: 235 year: 2012 ident: 2022060711565756000_71.4.716.20 article-title: Phyloseq: a Bioconductor package for handling and analysis of high-throughput phylogenetic sequence data publication-title: Pac Symp Biocomput – ident: 2022060711565756000_71.4.716.22 doi: 10.1093/mp/sst080 – ident: 2022060711565756000_71.4.716.32 doi: 10.1038/nature11053 – ident: 2022060711565756000_71.4.716.18 doi: 10.21105/joss.01686 – ident: 2022060711565756000_71.4.716.19 – ident: 2022060711565756000_71.4.716.2 doi: 10.1073/pnas.0504978102 – ident: 2022060711565756000_71.4.716.3 doi: 10.1038/nature12506 – ident: 2022060711565756000_71.4.716.6 doi: 10.1038/nature07540 – ident: 2022060711565756000_71.4.716.26 doi: 10.1016/j.chom.2018.03.011 – ident: 2022060711565756000_71.4.716.15 doi: 10.1093/bioinformatics/btu170 – ident: 2022060711565756000_71.4.716.24 doi: 10.1186/gb-2011-12-6-r60 – volume: 18 start-page: 855 year: 2020 ident: 2022060711565756000_71.4.716.10 article-title: Effects of fecal microbiota transplantation with oral capsules in obese patients publication-title: Clin Gastroenterol Hepatol doi: 10.1016/j.cgh.2019.07.006 – ident: 2022060711565756000_71.4.716.12 doi: 10.1126/science.1241214 – ident: 2022060711565756000_71.4.716.23 doi: 10.1126/science.aad8852 – ident: 2022060711565756000_71.4.716.27 doi: 10.1038/nrendo.2015.128 |
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| Snippet | ObjectiveThe impact of faecal microbiota transplantation (FMT) on microbiota engraftment in patients with metabolic syndrome is uncertain. We aimed to study... The impact of faecal microbiota transplantation (FMT) on microbiota engraftment in patients with metabolic syndrome is uncertain. We aimed to study whether... |
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| SubjectTerms | Antibiotics Body mass index Cholesterol Diabetes Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - complications Diabetes Mellitus, Type 2 - therapy Diet Dietitians Donors Double-Blind Method Double-blind studies Drug dosages enteric bacterial microflora Fecal Microbiota Transplantation Feces Gastrointestinal Microbiome Gut microbiota Humans Insulin Intervention Lifestyles lipoprotein-cholesterol Liver Metabolic syndrome Metagenomics Microbiota Obesity Obesity - complications Obesity - microbiology Obesity - therapy Probiotics Transplantation Treatment Outcome Weight control |
| Title | Microbiota engraftment after faecal microbiota transplantation in obese subjects with type 2 diabetes: a 24-week, double-blind, randomised controlled trial |
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