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 ISRCTN58082603; Pre-results.
- ulcerative colitis
- faecal microbiota transplantation
- feasibility study
- randomised trial
- quality of life
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Contributors DAH and ADR are responsible for the idea for the trial. MJ, ALC, ADR, MDH, SI, JK, APD, PER, TSW, GJJ, JGW and DAH have drafted and the manuscript and/or provided critical revision. ADR, MDH, SI, JK, APD, PER, TSW, GJJ, JGW and DAH have made substantial contributions to the conception and design of the work and subsequent protocol revisions. MJ, ALC, ADR, MDH, SI, JK, APD, PER TSW, GJJ, JGW and DAH all agree to be accountable for all aspects of work ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding This study is funded by Abertawe Bro Morgannwg University’s (ABMU) Local Health Board (LHB) Research and Development Department Pathway to Portfolio monies and has been externally peer reviewed by the ABMU LHB Joint Scientific Research Committee. Infrastructure support was provided by the National Institute for Health Research (NIHR) Imperial Biomedical Research Centre (BRC). ABMU’s Health Board will assume overall responsibility for the trial as a sponsor.
Competing interests None declared.
Patient consent Not required.
Ethics approval Research Ethics Committee (Wales REC6) REC reference 15/WA/0262.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators Departments of Colorectal Surgery and Gastroenterology, Swansea (Mark Davies, Martyn Evans, Greg Taylor, Shahzad Ather, Chandra Sekaran, Umesh Khot, John Beynon, Umakant Dave, Mesbah Rahman, Linzi Thomas, Lisa Williams, Sophie Henson, Chin-Lye Ch’ng, Mithun Nagari, Jagadish Nagaraj, Praveen Eadala) Departments of Gastroenterology and Colorectal Surgery at Cardiff and Vale University Health Board (lead investigator Barney Hawthorne) and Aneurin Bevan Health Board (lead investigators Vivek Goel and Gethin Williams).
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