Actively Recruiting
A Multi-centre, Randomised Controlled Trial Comparing Fecal Microbiota Transplantation to Placebo in an Expanded Ulcerative Colitis Population: a Feasibility Study (FRONTIER-UC)
Led by University of Alberta · Updated on 2026-06-04
85
Participants Needed
2
Research Sites
39 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
Researchers are evaluating fecal microbiota transplantation (FMT) for patients with active ulcerative colitis (UC) in this multi-centre, randomized, double-blind, placebo-controlled feasibility trial. The goal is to see if a larger full-scale study comparing FMT to placebo in an expanded UC population is possible and practical. Participants will include adults with active UC, recruited from three Canadian healthcare centers. Participants will be assigned to one of two groups: either to add FMT capsules to their current therapy or to start or switch to a new advanced medication alongside FMT. The treatment involves oral lyophilized fecal microbiota transplantation (LFMT) capsules or placebo capsules that look identical. The dosing includes an induction phase with higher capsule counts followed by a maintenance phase over several weeks. Throughout the study, participants will take capsules daily for up to 24 weeks, beginning with an induction phase of 1 week at 4 capsules per day, then 1 week at 2 capsules per day, followed by 6 weeks at 1 capsule daily, and then a maintenance phase of 16 weeks with 1 capsule daily. Researchers will assess steroid-free endoscopic remission at 8 weeks as the primary outcome. Secondary measures include monitoring adverse events and quality of life assessments at various points. Safety and treatment effects will be closely followed during and after treatment.
CONDITIONS
Brief 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 for women of childbearing potential for at least 4 weeks prior and during the trial
- Willing and able to comply with all required study procedures
You will not qualify if you...
- Severe ulcerative colitis requiring hospitalization
- Diagnosis of Crohn's disease or indeterminate colitis
- Irritable bowel syndrome
- Intestinal infection within 4 weeks before enrollment
- Evidence of toxic megacolon or gastrointestinal perforation on imaging
- Planned colectomy
- Abdominal surgery within 60 days before enrollment
- Neutropenia with absolute neutrophil count less than 0.5 x 10^9/L
- Peripheral white blood cell count above 35.0 x 10^9/L with fever over 38C
- Planned or current use of another investigational product
- Uncontrolled medical conditions such as psychiatric disorders or substance abuse
- Severe underlying disease with expected survival less than 30 days
- Pregnancy or breastfeeding
- Unwillingness to stop non-dietary probiotics
- Antibiotic use 30 days before enrollment or expected need during study
- FMT within 6 months prior to enrollment
- Investigator's judgment that participation is not in the best interest of the patient
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 weeks
Participants receive lyophilized fecal microbiota transplantation or placebo capsules as adjunct or co-administration therapy for ulcerative colitis.
Daily capsule intake during induction and maintenance phases
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here