Clinical Trial

Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis

Study acronym: FUEL
Recruiting
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Summary
The investigators intend to screen for new donors, given that there may a donor effect (PubMed ID: 25857665), with some donors not inducing remission in any patient whilst others inducing remission in 20-40% of cases. It is important to give UC patients participating in RCTs stool that has been demonstrated to be effective in some patients. We therefore propose to conduct an open label study in patients with active UC to ensure new donors are effective at inducing remission in some patients. Patients that have FMT will relapse within 18 months (PubMed ID: 25857665) although further FMT therapy induces remission so it is possible that maintenance FMT will result in long term remission, but this needs evaluation. We will therefore follow UC patients that have responded to FMT long term in this open label study.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2021-06-10; most recent amendment 2024-09-30.
Status change: Not Yet Recruiting → Recruiting 2024-09-30
Trial Details
NCT Number NCT04926103
Lead Sponsor Hamilton Health Sciences Corporation
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions Ulcerative Colitis Flare
Enrollment 200 participants
Start Date 2022-07-01
Primary Completion 2028-10-01 (estimated)
Study Completion 2029-05-01 (estimated)
Updated on ClinicalTrials.gov 2024-10-01