This is a multi-centre, randomised controlled trial comparing fecal microbiota transplantation to placebo in an expanded ulcerative colitis population: a feasibility study (FRONTIER-UC) to determine whether a full-scale randomized controlled trial (RCT) to investigate fecal microbiota transplantation (FMT) in ulcerative colitis (UC) is feasible.
This is a randomized, double blind, placebo-controlled trial for UC patients with active disease. Participants will be grouped into one of two categories 1. Add to current therapy (i.e., adjunct therapy) or 2. Initiate or switch to a new advanced agent (i.e., co-administration) The study will recruit 85 outpatients at 3 Canadian healthcare centres
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
85
LFMT by oral capsules
Placebo capsules does not contain FMT
University of Calgary
Calgary, Alberta, Canada
NOT_YET_RECRUITINGUniversity of Alberta
Edmonton, Alberta, Canada
RECRUITINGSteroid-free endoscopic remission
Steroid-free endoscopic remission is defined as either 1. Mayo endoscopy score (MES)= 0 OR 2. MES=1 + FC \<150 µg/g
Time frame: At 8 weeks
Serious adverse events [SAE]
SAEs including infections attributable to FMT, hospitalization due to UC exacerbation or complications related to FMT, or colectomy due to UC
Time frame: up to week 24 or at time of withdrawal
Adverse outcomes
Adverse outcomes, including nausea, vomiting, worsening diarrhea or abdominal pain
Time frame: up to week 24 or upon withdrawal
Quality of Life- sIBDQ
Changes in health-related quality of life measures using the short IBD questionnaire (sIBDQ)
Time frame: Baseline to 8 weeks and 24 weeks
Quality of Life- WPAI-IBD
Changes in health-related quality of life measures using the work productivity and activity impairment questionnaire (WPAI-IBD)
Time frame: Baseline to 8 weeks and weeks 24
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