LFMT vs Placebo in New Biologic Start for Ulcerative Colitis
NCT05327790 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-05-06
Summary
To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.
Conditions
Interventions
- DRUG
-
Lyophilized fecal microbiota (LFMT)
vedolizumab or ustekinumab + FMT vs placebo
- OTHER
-
Placebo
Placebo
Sponsors & Collaborators
-
University of Alberta
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-03
- Primary Completion
- 2027-03-31
- Completion
- 2027-03-31
Countries
- Canada
Study Locations
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