Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population
Phase 1 · Testing Lyophilized Fecal Microbiota Transplantation (LFMT) · 2 sites · University of Alberta
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Lyophilized Fecal Microbiota Transplantation (LFMT) as a possible treatment. Condition(s) listed: Ulcerative Colitis, Inflammatory Bowel Diseases and Clostridioides Difficile Infection.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 18 years of age or older
- Able to provide informed consent
- Established UC diagnosis through standard endoscopic and histologic criteria
Plus 3 more requirement(s). There are also 17 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 85 participants are expected to take part.
- Start date: 2026-03-01.
- Main results expected around 2028-03-01 (estimate from the record).
- 2 study sites listed (1 marked recruiting) in Canada.
Main thing being measured
- Steroid-free endoscopic remission (At 8 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis; Inflammatory Bowel Diseases; Clostridioides Difficile Infection |
| Lead sponsor | University of Alberta |
| Collaborators | University of Calgary |
| Enrollment | 85 (estimated) |
| Start date | 2026-03-01 |
| Primary completion (est.) | 2028-03-01 |
| First posted | 2026-02-10 |
| Last updated | 2026-06-04 |
| Official title | A Multi-centre, Randomised Controlled Trial Comparing Fecal Microbiota Transplantation to Placebo in an Expanded Ulcerative Colitis Population: a Feasibility Study (FRONTIER-UC) |
| ClinicalTrials.gov ID | NCT07401680 |
Interventions
- Lyophilized Fecal Microbiota Transplantation (LFMT) (Other)
LFMT by oral capsules - Placebo (Other)
Placebo capsules does not contain FMT
Full eligibility criteria (from the record)
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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Calgary | Calgary, Alberta | Canada | Not yet recruiting |
| University of Alberta | Edmonton, Alberta | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.