Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol
Permanent link
https://hdl.handle.net/10037/32488Date
2023-12-27Type
Journal articleTidsskriftartikkel
Peer reviewed
Author
Hanssen, Hege Marie; Fjellstad, Maria Serafia; Skjevling, Linn; Johnsen, Peter Holger; Goll, Rasmus; Almå, Kristin Helen; Kulseng, Bård Eirik; Valle, Per ChristianAbstract
The research on obesity and gut microbiota has yielded promising results regarding weight reduction and metabolic health, but more research is needed to better understand the relationship between gut microbiota and severe obesity. This study could show proof of concept that gut microbiota from a lean donor could, in addition to lifestyle intervention, contribute to weight reduction in people suffering from severe obesity.
Method and analysis - This study aims to investigate if a fecal microbiota transplantation (FMT) from a lean donor leads to weight reduction in participants suffering from severe obesity. The study is a single-centre, double-blinded, placebo-controlled, parallel-group study with 60 participants. Participants will be randomised 1:1 for FMT from a lean donor or placebo. FMT or placebo will be delivered once by enema.
We will include participants from the outpatient clinic for severe obesity, at the Medical Department, University Hospital of North Norway, Harstad, by invitation only. The study has a follow-up period of 12 months, with study visits of 3, 6 and 12 months post FMT. The primary endpoint is a weight reduction of ≥10%, 12 months after intervention.
The results of the study will be published in open access journals. At the end of the study, the participants will receive information on which treatment group they belong to.
Ethics and dissemination - The Regional Ethical Committee in North Norway (REK) approved the study protocol (2017/1655/REK Nord). We plan to present the results from the study at (inter)national conferences and publish in open-access general peer-reviewed journals. The enema method for FMT administration used in this study was developed by our study team.