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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Online Access: | https://hdl.handle.net/10037/32488 https://doi.org/10.1136/bmjopen-2023-073242 |
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ftunivtroemsoe:oai:munin.uit.no:10037/32488 2024-02-11T10:06:56+01:00 Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol Hanssen, Hege Marie Fjellstad, Maria Serafia Skjevling, Linn Johnsen, Peter Holger Goll, Rasmus Almå, Kristin Helen Kulseng, Bård Eirik Valle, Per Christian 2023-12-27 https://hdl.handle.net/10037/32488 https://doi.org/10.1136/bmjopen-2023-073242 eng eng BMJ Publishing Group BMJ Open Helse Nord RHF: HNF1411-18 Hanssen, Fjellstad, Skjevling, Johnsen, Goll, Almå, Kulseng, Valle. Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol. BMJ Open. 2023 FRIDAID 2220055 doi:10.1136/bmjopen-2023-073242 2044-6055 https://hdl.handle.net/10037/32488 Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) Copyright 2023 The Author(s) https://creativecommons.org/licenses/by-nc/4.0 VDP::Medisinske fag: 700::Klinisk medisinske fag: 750::Gasteroenterologi: 773 VDP::Midical sciences: 700::Clinical medical sciences: 750::Gastroenterology: 773 Mikrobiologi / Microbiology Overvekt / Overweight Journal article Tidsskriftartikkel Peer reviewed publishedVersion 2023 ftunivtroemsoe https://doi.org/10.1136/bmjopen-2023-073242 2024-01-18T00:08:05Z 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 |
topic |
VDP::Medisinske fag: 700::Klinisk medisinske fag: 750::Gasteroenterologi: 773 VDP::Midical sciences: 700::Clinical medical sciences: 750::Gastroenterology: 773 Mikrobiologi / Microbiology Overvekt / Overweight |
spellingShingle |
VDP::Medisinske fag: 700::Klinisk medisinske fag: 750::Gasteroenterologi: 773 VDP::Midical sciences: 700::Clinical medical sciences: 750::Gastroenterology: 773 Mikrobiologi / Microbiology Overvekt / Overweight Hanssen, Hege Marie Fjellstad, Maria Serafia Skjevling, Linn Johnsen, Peter Holger Goll, Rasmus Almå, Kristin Helen Kulseng, Bård Eirik Valle, Per Christian Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol |
topic_facet |
VDP::Medisinske fag: 700::Klinisk medisinske fag: 750::Gasteroenterologi: 773 VDP::Midical sciences: 700::Clinical medical sciences: 750::Gastroenterology: 773 Mikrobiologi / Microbiology Overvekt / Overweight |
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 |
Hanssen, Hege Marie Fjellstad, Maria Serafia Skjevling, Linn Johnsen, Peter Holger Goll, Rasmus Almå, Kristin Helen Kulseng, Bård Eirik Valle, Per Christian |
author_facet |
Hanssen, Hege Marie Fjellstad, Maria Serafia Skjevling, Linn Johnsen, Peter Holger Goll, Rasmus Almå, Kristin Helen Kulseng, Bård Eirik Valle, Per Christian |
author_sort |
Hanssen, Hege Marie |
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/10037/32488 https://doi.org/10.1136/bmjopen-2023-073242 |
geographic |
Norway |
geographic_facet |
Norway |
genre |
North Norway |
genre_facet |
North Norway |
op_relation |
BMJ Open Helse Nord RHF: HNF1411-18 Hanssen, Fjellstad, Skjevling, Johnsen, Goll, Almå, Kulseng, Valle. Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol. BMJ Open. 2023 FRIDAID 2220055 doi:10.1136/bmjopen-2023-073242 2044-6055 https://hdl.handle.net/10037/32488 |
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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1790604961349894144 |