Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol
Introduction - Obesity is one of the main threats to public health in western countries and increases the risk of several diseases, overall morbidity and mortality. Sustained weight loss will reduce risk factors and improve several obesity comorbidities. Options are conservative treatment such as li...
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ftunivtroemsoe:oai:munin.uit.no:10037/32369 2024-02-04T10:03:05+01:00 Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol Valle, Per Christian Skjevling, Linn Johnsen, Peter Holger Fjellstad, Maria Serafia Almå, Kristin Helen Kulseng, Bård Eirik Goll, Rasmus 2023-12-27 https://hdl.handle.net/10037/32369 https://doi.org/10.1136/bmjopen-2023-073242 eng eng BMJ Publishing Group BMJ Open Valle, Skjevling, Johnsen, Fjellstad, Almå, Kulseng, Goll. Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol . BMJ Open. 2023 FRIDAID 2219800 doi:10.1136/bmjopen-2023-073242 2044-6055 https://hdl.handle.net/10037/32369 Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) Copyright 2023 The Author(s) https://creativecommons.org/licenses/by-nc/4.0 Journal article Tidsskriftartikkel Peer reviewed publishedVersion 2023 ftunivtroemsoe https://doi.org/10.1136/bmjopen-2023-073242 2024-01-11T00:08:07Z Introduction - Obesity is one of the main threats to public health in western countries and increases the risk of several diseases, overall morbidity and mortality. Sustained weight loss will reduce risk factors and improve several obesity comorbidities. Options are conservative treatment such as lifestyle changes, bariatric surgery or medications. Conservative treatment has a low success rate, and bariatric surgery is typically not reversible, with the risk of complications and recurrences. Treatment of obesity with medications has in recent years shown great promise, but the side effects are many, and the long-term effect is unknown. There is also a need for an option for patients where surgery has contraindications and conservative follow-up does not succeed. 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 ... Article in Journal/Newspaper North Norway University of Tromsø: Munin Open Research Archive Norway BMJ Open 13 12 e073242 |
institution |
Open Polar |
collection |
University of Tromsø: Munin Open Research Archive |
op_collection_id |
ftunivtroemsoe |
language |
English |
description |
Introduction - Obesity is one of the main threats to public health in western countries and increases the risk of several diseases, overall morbidity and mortality. Sustained weight loss will reduce risk factors and improve several obesity comorbidities. Options are conservative treatment such as lifestyle changes, bariatric surgery or medications. Conservative treatment has a low success rate, and bariatric surgery is typically not reversible, with the risk of complications and recurrences. Treatment of obesity with medications has in recent years shown great promise, but the side effects are many, and the long-term effect is unknown. There is also a need for an option for patients where surgery has contraindications and conservative follow-up does not succeed. 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 ... |
format |
Article in Journal/Newspaper |
author |
Valle, Per Christian Skjevling, Linn Johnsen, Peter Holger Fjellstad, Maria Serafia Almå, Kristin Helen Kulseng, Bård Eirik Goll, Rasmus |
spellingShingle |
Valle, Per Christian Skjevling, Linn Johnsen, Peter Holger Fjellstad, Maria Serafia Almå, Kristin Helen Kulseng, Bård Eirik Goll, Rasmus Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol |
author_facet |
Valle, Per Christian Skjevling, Linn Johnsen, Peter Holger Fjellstad, Maria Serafia Almå, Kristin Helen Kulseng, Bård Eirik Goll, Rasmus |
author_sort |
Valle, Per Christian |
title |
Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol |
title_short |
Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol |
title_full |
Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol |
title_fullStr |
Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol |
title_full_unstemmed |
Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol |
title_sort |
randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol |
publisher |
BMJ Publishing Group |
publishDate |
2023 |
url |
https://hdl.handle.net/10037/32369 https://doi.org/10.1136/bmjopen-2023-073242 |
geographic |
Norway |
geographic_facet |
Norway |
genre |
North Norway |
genre_facet |
North Norway |
op_relation |
BMJ Open Valle, Skjevling, Johnsen, Fjellstad, Almå, Kulseng, Goll. Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol . BMJ Open. 2023 FRIDAID 2219800 doi:10.1136/bmjopen-2023-073242 2044-6055 https://hdl.handle.net/10037/32369 |
op_rights |
Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) Copyright 2023 The Author(s) https://creativecommons.org/licenses/by-nc/4.0 |
op_doi |
https://doi.org/10.1136/bmjopen-2023-073242 |
container_title |
BMJ Open |
container_volume |
13 |
container_issue |
12 |
container_start_page |
e073242 |
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1789970236207792128 |