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RECRUITING
NCT05006430
PHASE1/PHASE2

Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis

Sponsor: Prasun Kumar Jalal

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Fecal Microbiota Transplantation

It's an intestinal microbial suspension prepared form stool obtained from carefully and thoroughly screened healthy human donors.

OTHER

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