NCT05548452

Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease

Intestinal Microbiota Transplant in Alcohol-Associated Chronic Liver Disease and Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

These intestinal microbiota transplant (IMT) capsules are an investigational drug, which means it has not been approved by the U. S. Food and Drug Administration (FDA). In this study, drug name will be compared to placebo (a look-alike inactive substance, a "sugar pill"). Participants will be randomly assigned (like the flip of a coin) to receive either IMT capsules or placebo capsules. Participants have an equal chance of being assigned to any one of the groups. In this study, participants will be asked to do the following things: 1. Visit VCU medical center up to 8 times for study visits 2. Take either IMT capsule or the placebo, depending upon which group they are assigned to; these capsules will be given twice on enrollment and after one month 3. Have blood drawn, urine and stool collected at each visit 4. Have testing done to determine the speed of brain function 5. Keep a diary at home 6. Take surveys and answer questions about general health, alcohol craving and consumption and how they are feeling. 7. Give permission for the researchers to collect information about liver disease, alcohol and mental health from medical records. Participation in this study will last up to 7 months.

Conditions

• Liver Disease; Alcohol-Related
• Cirrhosis
• Alcohol Use Disorder

Interventions

Type	Name	Description
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")

Timeline

• Start date: 2022-11-21
• Primary completion: 2026-11-30
• Completion: 2026-12-30
• First posted: 2022-09-21
• Last updated: 2025-05-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study