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Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis
The purpose of the study is to evaluate the efficacy and safety of lyophilized PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage. This study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential associations with clinical outcomes in context of active FMT or placebo administration.
Details
| Lead sponsor | The University of Texas Health Science Center, Houston |
|---|---|
| Phase | PHASE2 |
| Status | RECRUITING |
| Enrolment | 58 |
| Start date | Mon Sep 14 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Dec 31 2027 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Adults With Ulcerative Colitis
Interventions
- PRIM-DJ2727
- Placebos
Countries
United States