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Protocol for faecal microbiota transplantation in ulcerative colitis (FMTUC): a randomised feasibility study / Maki Jitsumura; Andrew Cunningham; Matthew Hitchings; Saiful Islam; Angharad Davies; Paula Row; Andrew Riddell; James Kinross; Tom Wilkinson; Gareth Jenkins; John Williams; Dean Harris

BMJ Open, Volume: 8

Swansea University Author: Row, Paula

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DOI (Published version): 10.1136/bmjopen-2018-021987

Abstract

BACKGROUND:The interaction of the gut microbiota with the human host is implicated in the pathogenesis of inflammatory and immunological diseases including ulcerative colitis (UC). Faecal microbiota transplantation (FMT) as a method of restoring gut microbial diversity is of increasing interest as a...

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Published in: BMJ Open
Published: 2018
Online Access: https://bmjopen.bmj.com/content/8/10/e021987
URI: https://cronfa.swan.ac.uk/Record/cronfa46037
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fullrecord <?xml version="1.0"?><rfc1807><datestamp>2018-12-13T12:56:51Z</datestamp><bib-version>v2</bib-version><id>46037</id><entry>2018-11-21</entry><title>Protocol for faecal microbiota transplantation in ulcerative colitis (FMTUC): a randomised feasibility study</title><alternativeTitle></alternativeTitle><author>Paula Row</author><firstname>Paula</firstname><surname>Row</surname><active>true</active><ORCID/><ethesisStudent>false</ethesisStudent><sid>99bb528b2f8fb62aabbdad101d53ba96</sid><email>5e3f0c0014cda644ea5172c5898bc191</email><emailaddr>NP47drFu3K/NNbWm4Onwz4JSbZF11mHm1K8NtCGVMYw=</emailaddr><date>2018-11-21</date><deptcode>PMSC</deptcode><abstract>BACKGROUND:The interaction of the gut microbiota with the human host is implicated in the pathogenesis of inflammatory and immunological diseases including ulcerative colitis (UC). Faecal microbiota transplantation (FMT) as a method of restoring gut microbial diversity is of increasing interest as a therapeutic approach in the management of UC. The current literature lacks consensus about the dose of FMT, route of administration and duration of response.METHODS AND ANALYSIS:This single-blinded randomised trial will explore the feasibility of FMT in 30 treatment-na&#xEF;ve patients with histologically confirmed distal UC limited to the recto-sigmoid region (up to 40&#x2009;cm from the anal verge). This study aims to estimate the magnitude of treatment response to FMT under controlled conditions. The intervention (FMT) will be administered by rectal retention enema. It will test the feasibility of randomising patients to: (i) single FMT dose, (ii) five daily FMT doses or (iii) control (no FMT dose). All groups will receive standard antibiotic gut decontamination and bowel preparation before FMT. Recruitment will take place over a 24-month period with a 12-week patient follow-up. Trial objectives include evaluation of the magnitude of treatment response to FMT, investigation of the clinical value of metabolic phenotyping for predicting the clinical response to FMT and testing the recruitment rate of donors and patients for a study in FMT. This feasibility trial will enable an estimate of number of patients needed, help determine optimal study conditions and inform the choice of endpoints for a future definitive phase III study.ETHICS AND DISSEMINATION:The trial is approved by the regional ethics committee and is sponsored by Abertawe Bro Morgannwg University's Health Board. Written informed consent from all patients will be obtained. Serious adverse events will be reported to the sponsor. 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spelling 2018-12-13T12:56:51Z v2 46037 2018-11-21 Protocol for faecal microbiota transplantation in ulcerative colitis (FMTUC): a randomised feasibility study Paula Row Paula Row true false 99bb528b2f8fb62aabbdad101d53ba96 5e3f0c0014cda644ea5172c5898bc191 NP47drFu3K/NNbWm4Onwz4JSbZF11mHm1K8NtCGVMYw= 2018-11-21 PMSC BACKGROUND:The interaction of the gut microbiota with the human host is implicated in the pathogenesis of inflammatory and immunological diseases including ulcerative colitis (UC). Faecal microbiota transplantation (FMT) as a method of restoring gut microbial diversity is of increasing interest as a therapeutic approach in the management of UC. The current literature lacks consensus about the dose of FMT, route of administration and duration of response.METHODS AND ANALYSIS:This single-blinded randomised trial will explore the feasibility of FMT in 30 treatment-naïve patients with histologically confirmed distal UC limited to the recto-sigmoid region (up to 40 cm from the anal verge). This study aims to estimate the magnitude of treatment response to FMT under controlled conditions. The intervention (FMT) will be administered by rectal retention enema. It will test the feasibility of randomising patients to: (i) single FMT dose, (ii) five daily FMT doses or (iii) control (no FMT dose). All groups will receive standard antibiotic gut decontamination and bowel preparation before FMT. Recruitment will take place over a 24-month period with a 12-week patient follow-up. Trial objectives include evaluation of the magnitude of treatment response to FMT, investigation of the clinical value of metabolic phenotyping for predicting the clinical response to FMT and testing the recruitment rate of donors and patients for a study in FMT. This feasibility trial will enable an estimate of number of patients needed, help determine optimal study conditions and inform the choice of endpoints for a future definitive phase III study.ETHICS AND DISSEMINATION:The trial is approved by the regional ethics committee and is sponsored by Abertawe Bro Morgannwg University's Health Board. Written informed consent from all patients will be obtained. Serious adverse events will be reported to the sponsor. Trial results will be disseminated via peer review publication and shared with trial participants.TRIAL REGISTRATION NUMBER:ISRCTN 58082603; Pre-results.© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Journal article BMJ Open 8 faecal microbiota transplantation; feasibility study; microbiome; quality of life; randomised trial; ulcerative colitis 18 10 2018 2018-10-18 10.1136/bmjopen-2018-021987 https://bmjopen.bmj.com/content/8/10/e021987 Swansea University Medical School Medicine CMED PMSC None None 2018-12-13T12:56:51Z 2018-11-21T19:47:24Z Swansea University Medical School Medicine Maki Jitsumura 1 Andrew Cunningham 2 Matthew Hitchings 3 Saiful Islam 4 Angharad Davies 5 Paula Row 6 Andrew Riddell 7 James Kinross 8 Tom Wilkinson 9 Gareth Jenkins 10 John Williams 11 Dean Harris 12 0046037-13122018125524.pdf 46037.pdf 2018-12-13T12:55:24Z Output 520847 application/pdf VoR true Published to Cronfa 13/12/2018 2018-12-12T00:00:00 Released under the terms of a Creative Commons Attribution Non Commercial License (CC BY-NC 4.0). true eng
title Protocol for faecal microbiota transplantation in ulcerative colitis (FMTUC): a randomised feasibility study
spellingShingle Protocol for faecal microbiota transplantation in ulcerative colitis (FMTUC): a randomised feasibility study
Row, Paula
title_short Protocol for faecal microbiota transplantation in ulcerative colitis (FMTUC): a randomised feasibility study
title_full Protocol for faecal microbiota transplantation in ulcerative colitis (FMTUC): a randomised feasibility study
title_fullStr Protocol for faecal microbiota transplantation in ulcerative colitis (FMTUC): a randomised feasibility study
title_full_unstemmed Protocol for faecal microbiota transplantation in ulcerative colitis (FMTUC): a randomised feasibility study
title_sort Protocol for faecal microbiota transplantation in ulcerative colitis (FMTUC): a randomised feasibility study
author_id_str_mv 99bb528b2f8fb62aabbdad101d53ba96
author_id_fullname_str_mv 99bb528b2f8fb62aabbdad101d53ba96_***_Row, Paula
author Row, Paula
author2 Maki Jitsumura
Andrew Cunningham
Matthew Hitchings
Saiful Islam
Angharad Davies
Paula Row
Andrew Riddell
James Kinross
Tom Wilkinson
Gareth Jenkins
John Williams
Dean Harris
format Journal article
container_title BMJ Open
container_volume 8
publishDate 2018
institution Swansea University
doi_str_mv 10.1136/bmjopen-2018-021987
college_str Swansea University Medical School
hierarchytype
hierarchy_top_id swanseauniversitymedicalschool
hierarchy_top_title Swansea University Medical School
hierarchy_parent_id swanseauniversitymedicalschool
hierarchy_parent_title Swansea University Medical School
department_str Medicine{{{_:::_}}}Swansea University Medical School{{{_:::_}}}Medicine
url https://bmjopen.bmj.com/content/8/10/e021987
document_store_str 1
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description BACKGROUND:The interaction of the gut microbiota with the human host is implicated in the pathogenesis of inflammatory and immunological diseases including ulcerative colitis (UC). Faecal microbiota transplantation (FMT) as a method of restoring gut microbial diversity is of increasing interest as a therapeutic approach in the management of UC. The current literature lacks consensus about the dose of FMT, route of administration and duration of response.METHODS AND ANALYSIS:This single-blinded randomised trial will explore the feasibility of FMT in 30 treatment-naïve patients with histologically confirmed distal UC limited to the recto-sigmoid region (up to 40 cm from the anal verge). This study aims to estimate the magnitude of treatment response to FMT under controlled conditions. The intervention (FMT) will be administered by rectal retention enema. It will test the feasibility of randomising patients to: (i) single FMT dose, (ii) five daily FMT doses or (iii) control (no FMT dose). All groups will receive standard antibiotic gut decontamination and bowel preparation before FMT. Recruitment will take place over a 24-month period with a 12-week patient follow-up. Trial objectives include evaluation of the magnitude of treatment response to FMT, investigation of the clinical value of metabolic phenotyping for predicting the clinical response to FMT and testing the recruitment rate of donors and patients for a study in FMT. This feasibility trial will enable an estimate of number of patients needed, help determine optimal study conditions and inform the choice of endpoints for a future definitive phase III study.ETHICS AND DISSEMINATION:The trial is approved by the regional ethics committee and is sponsored by Abertawe Bro Morgannwg University's Health Board. Written informed consent from all patients will be obtained. Serious adverse events will be reported to the sponsor. Trial results will be disseminated via peer review publication and shared with trial participants.TRIAL REGISTRATION NUMBER:ISRCTN 58082603; Pre-results.© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
published_date 2018-10-18T06:16:15Z
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