NCT07401680 Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population
| NCT ID | NCT07401680 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Alberta |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 85 participants in total. It began in 2026-03-01 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07401680 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07401680 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07401680 currently recruiting?
Yes, NCT07401680 is actively recruiting participants. Contact the research team at dkao@ualberta.ca for enrollment information.
Where is the NCT07401680 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada.
Who is sponsoring the NCT07401680 clinical trial?
NCT07401680 is sponsored by University of Alberta. The trial plans to enroll 85 participants.
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