Protocol for the Gut Bugs Trial: a randomised double-blind placebo-controlled trial of gut microbiome transfer for the treatment of obesity in adolescents.

Show simple item record Leong, Karen en Jayasinghe, Thilini N en Behrensdorf Derraik, Jose en Albert, Benjamin en Chiavaroli, Valentina en Svirskis, Darren en Beck, Kathryn L en Conlon, Cathryn A en Jiang, Yannan en Schierding, William en Vatanen, Tommi en Holland, David J en O'Sullivan, Justin en Cutfield, Wayne en 2019-05-27T02:43:53Z en 2019-04-20 en
dc.identifier.citation BMJ open 9(4):e026174 20 Apr 2019 en
dc.identifier.issn 2044-6055 en
dc.identifier.uri en
dc.description.abstract INTRODUCTION:Animal studies showed that germ-free mice inoculated with normal mouse gut bacteria developed obesity, insulin resistance and higher triglyceride levels, despite similar food intake. In humans, an association has been found between obesity and gut microbiome dysbiosis. However, gut microbiome transfer has not been evaluated for the treatment of human obesity. We will examine the effectiveness of gut microbiome transfer using encapsulated material for the treatment of obesity in adolescents. METHODS AND ANALYSIS:A two-arm, double-blind, placebo-controlled, randomised clinical trial of a single course of gut microbiome transfer will be conducted in 80 obese [body mass index (BMI) ≥30 kg/m2] adolescents (males and females, aged 14-18 years) in Auckland, New Zealand. Healthy lean donors (males and females, aged 18-28 years) will provide fresh stool samples from which bacteria will be isolated and double encapsulated. Participants (recipients) will be randomised at 1:1 to control (placebo) or treatment (gut microbiome transfer), stratified by sex. Recipients will receive 28 capsules over two consecutive mornings (~14 mL of frozen microbial suspension or saline). Clinical assessments will be performed at baseline, 6, 12 and 26 weeks, and will include: anthropometry, blood pressure, fasting metabolic markers, dietary intake, physical activity levels and health-related quality of life. Insulin sensitivity (Matsuda index), gut microbiota population structure characterised by 16S rRNA amplicon sequencing and body composition (using dual-energy X-ray absorptiometry) will be assessed at baseline, 6, 12 and 26 weeks. 24-hour ambulatory blood pressure monitoring will be performed at baseline and at 6 weeks. The primary outcome is BMI SD scores (SDS) at 6 weeks, with BMI SDS at 12 and 26 weeks as secondary outcomes. Other secondary outcomes include insulin sensitivity, adiposity (total body fat percentage) and gut microbial composition at 6, 12 and 26 weeks. Statistical analysis will be performed on the principle of intention to treat. ETHICS AND DISSEMINATION:Ethics approval was provided by the Northern A Health and Disability Ethics Committee (Ministry of Health, New Zealand; 16/NTA/172). The trial results will be published in peer-reviewed journals and presented at international conferences. TRIAL REGISTRATION NUMBER:ACTRN12615001351505; Pre-results. en
dc.format.medium Electronic en
dc.language eng en
dc.relation.ispartofseries BMJ open en
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. en
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dc.title Protocol for the Gut Bugs Trial: a randomised double-blind placebo-controlled trial of gut microbiome transfer for the treatment of obesity in adolescents. en
dc.type Journal Article en
dc.identifier.doi 10.1136/bmjopen-2018-026174 en
pubs.issue 4 en
pubs.begin-page e026174 en
pubs.volume 9 en
dc.rights.holder Copyright: The authors en
pubs.publication-status Published en
dc.rights.accessrights en
pubs.subtype protocol en
pubs.subtype Research Support, Non-U.S. Gov't en
pubs.subtype Journal Article en
pubs.elements-id 769946 en Liggins Institute en Medical and Health Sciences en Pharmacy en School of Medicine en Paediatrics Child & Youth Hlth en Science en Statistics en
dc.identifier.eissn 2044-6055 en
pubs.record-created-at-source-date 2019-04-22 en
pubs.dimensions-id 31005929 en

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