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Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease

NCT05548452 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-06

No results posted yet for this study

Summary

The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking.

Conditions

Interventions

DRUG

Intestinal Microbiota Transplant (IMT) Capsules

Capsules containing freeze-dried intestinal microbiota from healthy human donors

DRUG

Placebo Capsules

Capsules containing an inactive substance ("sugar pill")

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Jasmohan S Bajaj, MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-21
Primary Completion
2026-11-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05548452 on ClinicalTrials.gov