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A Phase I/II, Double Blinded, Placebo Controlled, Single-center Study of Fecal Microbiota Transplant (FMT) for the Treatment of Active Pediatric Ulcerative Colitis and Pediatric Active Crohn's Colitis
The primary aims of this phase I/II, randomized, placebo controlled study are the assessment of safety and tolerability of universal donor FMT compared to placebo in pediatric and young adult subjects (ages 5 years through 30 years) with active ulcerative colitis (UC) or active Crohn's colitis (CD) who have failed, are intolerant to, or have refused traditional first-line maintenance therapy. Secondary objectives include the identification biomarkers in both donor and recipient that may confer a clinical response and to establish whether or not ongoing FMT maintenance therapy is required for maintenance of clinical benefit in pediatric UC or pediatric CD.
Details
| Lead sponsor | Stacy A. Kahn |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 15 |
| Start date | 2015-11 |
| Completion | 2019-04-08 |
Conditions
- Inflammatory Bowel Diseases
- Ulcerative Colitis
- Crohn Disease
Interventions
- Fecal Microbiota Transplant (FMT)
- Placebo
Primary outcomes
- 1. Safety and Tolerability of Universal Donor FMT Compared to Placebo: FMT-related Adverse Events Grade 2 or Above — At 8 weeks after start of FMT up to 6 months post treatment, an average of 10 months
Number of participants with FMT-related adverse events grade 2 or above experienced in each arm.
Countries
United States