Overview
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.
Description
This is a randomized, double blind, placebo-controlled trial for UC patients with active disease.
Participants will be grouped into one of two categories
- 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
Eligibility
Inclusion Criteria:
- 18 years of age or older
- Able to provide informed consent
- Established UC diagnosis through standard endoscopic and histologic criteria
- Active UC
- Use of effective contraception method for women of childbearing potential for at least 4 weeks prior to receiving study treatment and for the duration of the trial
- Willing and able to comply with all required study procedures
Exclusion Criteria:
- Severe UC requiring hospitalization
- Crohn's disease or indeterminate colitis
- Irritable bowel syndrome
- Intestinal infection within 4 weeks of enrollment
- Evidence of toxic megacolon or gastrointestinal perforation on imaging
- Planned colectomy
- Abdominal surgery within 60 days of enrollment
- Neutropenia with absolute neutrophil count \<0.5 x 109/L
- Peripheral white blood cell count \> 35.0 x 109/L and fever (\>38C)
- Planned or actively taking another investigational product
- Uncontrolled medical conditions such as psychiatric disorders or substance abuse
- Severe underlying disease such that the patient is not expected to survive for at least 30 days
- Pregnancy or breastfeeding
- Unwilling to discontinue non-dietary probiotic
- Antibiotic use 30 days prior to enrollment or anticipated need for systemic antibiotic use during study
- FMT for any reason within 6 months of enrollment
- Investigator's judgement that enrolment is not in the best interest of the patient
