Protocol for faecal microbiota transplantation in ulcerative colitis (FMTUC): a randomised feasibility study

Abstract

BackgroundThe 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 analysisThis 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 disseminationThe 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 numberISRCTN58082603; Pre-results.

Study of microbiome changes in patients with ulcerative colitis in the Central European part of Russia

“…UC is characterized by substantial changes in the mucous virobiota with functional distortion [ 11 ]. There is evidence that fecal microbiota transplantation can positively effect on patients with ulcerative colitis [ 12 , 13 , 14 ].…”

Fecal microbiota transplantation for ulcerative colitis: a prospective clinical study

“…Therefore, there is a requirement for new therapeutic strategies for the treatment of UC. Fecal microbiota transplantation (FMT) may be of therapeutic value in patients with UC by contributing to the repopulation of healthy intestinal flora [14][15][16][17]. However, conflicting results have been reported regarding the efficacy of this treatment.…”

Assessing the efficacy and safety of fecal microbiota transplantation and probiotic VSL#3 for active ulcerative colitis: A systematic review and meta-analysis

“…The other three were excluded from randomized controlled trials of pediatric UC [48][49][50]. The clinical standards of two experiments were different from those of other experiments [17,51]. A randomized controlled trial was excluded because of a lack of placebo control [52].…”