Lyophilized fecal microbiota transplant for adults with active ulcerative colitis
A Multi-centre, Randomised Controlled Trial Comparing Fecal Microbiota Transplantation to Placebo in an Expanded Ulcerative Colitis Population: a Feasibility Study (FRONTIER-UC)
This trial will test whether a dried (lyophilized) fecal microbiota transplant helps adults with active ulcerative colitis when added to their current treatment or started alongside a new advanced medication.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 2 sites (Calgary, Alberta and 1 other locations) |
| Trial ID | NCT07401680 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled Phase 1 feasibility trial will enroll 85 outpatients across three Canadian centres to compare lyophilized fecal microbiota transplantation (LFMT) with placebo in people with active ulcerative colitis. Participants will be randomized to receive LFMT or placebo either as an adjunct to their existing therapy or when initiating or switching to a new advanced agent. The study uses an oral, lyophilized FMT product and focuses on safety, tolerability, and early signals of clinical benefit to determine whether a full-scale randomized controlled trial is feasible. Standard clinical and laboratory monitoring will be performed and patients with severe or complicated disease are excluded.
Who should consider this trial
Good fit: Adults (18+) with an established diagnosis of active ulcerative colitis who can provide informed consent and attend outpatient visits are the intended participants.
Not a fit: Patients with severe UC requiring hospitalization, Crohn's disease or indeterminate colitis, recent intestinal infection, planned colectomy, recent abdominal surgery, or uncontrolled medical or psychiatric conditions are unlikely to be eligible or to benefit from this trial.
Why it matters
Potential benefit: If successful, LFMT could offer a new, non-antibiotic option to improve symptoms or induce remission in some people with active ulcerative colitis.
How similar studies have performed: Fecal microbiota transplantation is proven for recurrent C. difficile infection, but previous trials in ulcerative colitis have had mixed results and lyophilized oral formulations remain a relatively new approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years of age or older 2. Able to provide informed consent 3. Established UC diagnosis through standard endoscopic and histologic criteria 4. Active UC 5. 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 6. Willing and able to comply with all required study procedures Exclusion Criteria: 1. Severe UC requiring hospitalization 2. Crohn's disease or indeterminate colitis 3. Irritable bowel syndrome 4. Intestinal infection within 4 weeks of enrollment 5. Evidence of toxic megacolon or gastrointestinal perforation on imaging 6. Planned colectomy 7. Abdominal surgery within 60 days of enrollment 8. Neutropenia with absolute neutrophil count \<0.5 x 109/L 9. Peripheral white blood cell count \> 35.0 x 109/L and fever (\>38C) 10. Planned or actively taking another investigational product 11. Uncontrolled medical conditions such as psychiatric disorders or substance abuse 12. Severe underlying disease such that the patient is not expected to survive for at least 30 days 13. Pregnancy or breastfeeding 14. Unwilling to discontinue non-dietary probiotic 15. Antibiotic use 30 days prior to enrollment or anticipated need for systemic antibiotic use during study 16. FMT for any reason within 6 months of enrollment 17. Investigator's judgement that enrolment is not in the best interest of the patient
Where this trial is running
Calgary, Alberta and 1 other locations
- University of Calgary — Calgary, Alberta, Canada (Not_yet_recruiting)
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Study coordinator: Dina Kao, MD,FRCPC
- Email: dkao@ualberta.ca
- Phone: 780-233-6025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.