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Protocol for faecal microbiota transplantation in ulcerative colitis (FMTUC): a randomised feasibility study / M Jitsumura; AL Cunningham; Matthew Hitchings; S Islam; AP Davies; PE Row; AD Riddell; J Kinross; TS Wilkinson; G Jenkins; JG Williams; DA Harris
BMJ Open, Volume: 18, Issue: 8
Swansea University Author: Hitchings, Matthew
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DOI (Published version): 10.1136/bmjopen-2018-021987
The human gut microbiome has been implicated in a range of inflammatory and immunological diseases such as ulcerative colitis (UC). The use of faecal microbiota transplantation (FMT) as a therapy to combat said diseases is of significant interest, however the consensus on current protocols is lackin...
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The human gut microbiome has been implicated in a range of inflammatory and immunological diseases such as ulcerative colitis (UC). The use of faecal microbiota transplantation (FMT) as a therapy to combat said diseases is of significant interest, however the consensus on current protocols is lacking.This study aims to measure the response to FMT administered by rectal retention enema under controlled conditions. Inclusion status include for 30 treatment-naïve patients with histologically confirmed distal UC limited to the recto-sigmoid region (up to 40 cm from the anal verge). Patients will be randomly assigned to groups of (i) single FMT dose, (ii) five daily FMT doses or (iii) control (no FMT dose) prior to which all groups will receive standard antibiotic gut decontamination and bowel preparation. 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. Objectives to be scored are; clinical response to FMT, assessment of the clinical value of metabolic phenotyping for prediction of clinical response to FMT and testing the recruitment rate of donors and patients for a study in FMT
Swansea University Medical School