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Clinical Trial Summary

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.


Clinical Trial Description

Studies have shown that microbiota disturbances occur in patients with ulcerative colitis (UC). This study will evaluate safety and preliminary efficacy of microbiota replacement treatment in active UC, and changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT. Studies have shown that microbiota disturbances occur in patients with ulcerative colitis (UC). This study will evaluate safety and preliminary efficacy of microbiota replacement treatment in active UC, and changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05786404
Study type Interventional
Source The University of Texas Health Science Center, Houston
Contact Herbert L DuPont, MD
Phone 713 500 6687
Email herbert.l.dupont@uth.tmc.edu
Status Recruiting
Phase Phase 1
Start date December 15, 2023
Completion date December 15, 2027