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Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
Sponsor: The University of Texas Health Science Center, Houston
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.
Official title: A Randomized, Open-label, Pilot Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2023-12-15
Completion Date
2027-12-15
Last Updated
2024-05-10
Healthy Volunteers
No
Conditions
Interventions
PRIM-DJ2727 - FROZEN
Patients with active UC will receive induction dose of 100 grams of stool via frozen retention enema, Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727-FROZEN administered in clinic. This consists of microbiota suspension from well-screened donors. Twice filtered fecal microbiota product diluted in saline to 500 mL containing 100g of study drug will be administered as frozen enema induction dose
PRIM-DJ2727 - CAPSULES
Patients with active UC will receive induction dose of 100 grams of stool in orally administered enteric-coated capsules Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727-CAPSULES.These capsules consists of microbiota from well-screened donors. The induction dose of enteric-coated capsules will be derived from 100 grams stool.
Locations (1)
The University of Texas Health Science Center at Houston
Houston, Texas, United States