Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis

Part of paid clinical trials in Houston, Texas.

Sponsor
Prasun Kumar Jalal
Study ID
NCT05006430
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Alcoholic Hepatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Fecal Microbiota Transplantation — BIOLOGICAL
    It's an intestinal microbial suspension prepared form stool obtained from carefully and thoroughly screened healthy human donors.
  • Placebo — OTHER
    Placebo will be identical to the investigational product but will not contain fecal material.

Study Details

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.

Key Dates

Start date
Jan 21, 2023
Status verified
Aug 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Intervention Arm
    Subjects will receive Standard of Care (SOC), based on AASLD/EASL guidelines and one dose of PRIM-DJ2727 (30 grams of stool/dose \~ 3 capsules) every day for a week followed by once weekly for 3 weeks, amounting to total 10 doses. PRIM-DJ2727 (microbiota suspension) is an intestinal microbial suspension prepared form stool obtained from carefully and thoroughly screened healthy human donors. It will be provided by University of Texas School of Public Health.
  • Placebo Comparator: Placebo Arm
    Subjects will receive Standard of Care (SOC), based on AASLD/EASL guidelines and one dose of Placebo every day for a week followed by once weekly for 3 weeks, amounting to total 10 doses. Placebo will be identical to the investigational product but will not contain active PRIM-DJ2727.

Primary Outcome Measure

To Assess survival in patients with severe alcoholic hepatitis receiving PRIM-DJ2727 capsules in comparison to standard of care. [ Time Frame: [Day1 to 12 month] ]

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor St. Luke Medical CenterHoustonTexas77030
Prasun K. Jalal, MD
[email protected]
832-355-1424

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By research site
Baylor St. Luke Medical Center· Houston, TX

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