Actively Recruiting
Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population
Led by University of Alberta · Updated on 2026-05-08
85
Participants Needed
2
Research Sites
143 weeks
Total Duration
On this page
Sponsors
U
University of Alberta
Lead Sponsor
U
University of Calgary
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Able to provide informed consent
- Established ulcerative colitis diagnosis through standard endoscopic and histologic criteria
- Active ulcerative colitis
- 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
You will not qualify if you...
- Severe ulcerative colitis 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 10^9/L
- Peripheral white blood cell count > 35.0 x 10^9/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
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Calgary
Calgary, Alberta, Canada, T2N-1N4
Not Yet Recruiting
2
University of Alberta
Edmonton, Alberta, Canada, T6G2R3
Actively Recruiting
Research Team
D
Dina Kao, MD,FRCPC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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