NCT07401680RecruitingPhase 1
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)
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 85 (estimated)
- First submitted
- 27 Jan 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- University of Alberta
- Diseases
- Ulcerative colitis
- NCT number
- NCT07401680
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 85
- From 1 Mar 2026 to the primary completion date, 1 Mar 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Abdominal surgery within 60 days of enrollment
- Planned or actively taking another investigational product
- Antibiotic use 30 days prior to enrollment or anticipated need for systemic antibiotic use during study
Other illness
- 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
- 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
Lab values
- Neutropenia with absolute neutrophil count \<0.5 x 109/L
- Peripheral white blood cell count \> 35.0 x 109/L and fever (\>38C)
Other
- Severe UC requiring hospitalization
- Planned colectomy
- Pregnancy or breastfeeding
- Unwilling to discontinue non-dietary probiotic
- FMT for any reason within 6 months of enrollment
- Investigator's judgement that enrolment is not in the best interest of the patient
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Not yet recruiting |
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.