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 Interventional Study
Adults With Ulcerative Colitis
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
58 (estimated)
Sponsor
The University of Texas Health Science Center, Houston · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Adult ≥18 years of age 2. History of active UC in the past 12 months based on standard clinical, endoscopic, or histologic criteria. 3. Remission of UC based on clinical grounds (partial Mayo score of ≤2 with each subscore ≤1), and on stable maintenance therapy. 4. Sexually a…
Contacts

Herbert DuPont, md

713 500 6687

herbert.l.dupont@uth.tmc.edu

CONTACT

Zhi-Dong Jiang, Dr.PH

713 500 9371

zhi-dong.jiang@uth.tmc.edu

CONTACT