Clinical Trial

Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis

Recruiting Phase 2
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Summary
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-05-01; most recent amendment 2026-03-05.
Status change: Not Yet Recruiting → Recruiting 2021-01-21
Trial Details
NCT Number NCT04373473
Lead Sponsor The University of Texas Health Science Center, Houston
Conditions Adults With Ulcerative Colitis
Enrollment 58 participants
Start Date 2020-09-14
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-09