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Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis
Sponsor: Prasun Kumar Jalal
Summary
This is a single center, randomized, parallel assignment, and double-blind placebo-controlled pilot study to characterize the intestinal microbiome in patients with severe Alcoholic Hepatitis (SAH) and evaluate the safety and the trends in improvement of diversity of intestinal microbiome following administration of lyophilized capsules containing microbiota suspension from well screened health donors. The study aims to enroll 50 patients with SAH who will be randomly assigned in 1:1 where 25 patients will be assigned to receive orally administered lyophilized PRIM-DJ2727 and Standard of Care (SOC) and the other 25 patients will be assigned to receive placebo and SOC for 4 weeks.
Official title: Fecal Microbiome Changes Characterization and Safety Evaluation After Oral Administration of Lyophilized Capsules Containing Microbiota Suspension in Severe Alcoholic Hepatitis Patients: Double Blinded, Randomized, Placebo-Controlled Study.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2023-01-21
Completion Date
2025-06-30
Last Updated
2025-01-23
Healthy Volunteers
No
Conditions
Interventions
Fecal Microbiota Transplantation
It's an intestinal microbial suspension prepared form stool obtained from carefully and thoroughly screened healthy human donors.
Placebo
Placebo will be identical to the investigational product but will not contain fecal material.
Locations (1)
Baylor St. Luke Medical Center
Houston, Texas, United States