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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

NCT04373473 PHASE2 RECRUITING

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 sponsorThe University of Texas Health Science Center, Houston
PhasePHASE2
StatusRECRUITING
Enrolment58
Start dateMon Sep 14 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionFri Dec 31 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

United States