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Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis

NCT05006430 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-01-23

No results posted yet for this study

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.

Conditions

  • Alcoholic Hepatitis

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.

Sponsors & Collaborators

  • Prasun Kumar Jalal

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-21
Primary Completion
2025-06-30
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05006430 on ClinicalTrials.gov