Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population
A Multi-centre, Randomised Controlled Trial Comparing Fecal Microbiota Transplantation to Placebo in an Expanded Ulcerative Colitis Population: a Feasibility Study (FRONTIER-UC)
University of Alberta
85 participants
Mar 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria17
- 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
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Interventions
LFMT by oral capsules
Placebo capsules does not contain FMT
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07401680