Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis

Recruiting Phase 1 Interventional Study
Active Ulcerative Colitis (UC)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
The University of Texas Health Science Center, Houston · Other
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About This Trial

The study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT delivery via retention enema compared to lyophilized powder given in oral capsules as induction FMT in subjects with active UC. This study will also determine changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Diagnosis of active UC defined on clinical grounds (Partial Mayo score ≥ 3 with each subscore \>1) * Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the study. * Female subjects of childbearing po…
Contacts

Herbert L DuPont, MD

713 500 6687

herbert.l.dupont@uth.tmc.edu

CONTACT

Zhi-Dong Jiang, Dr.PH

713 500 9371

CONTACT