drugset / Trial / NCT05786404

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

NCT05786404 ↗

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-12-15
Primary completion
2026-12-15
Completion
2027-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject PRIM-DJ2727 Other / unclassified 100 g Rectal

Indications