RecruitingPhase 1Phase 2NCT05548452

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


Sponsor

Virginia Commonwealth University

Enrollment

80 participants

Start Date

Nov 21, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether intestinal microbiota transplantation (IMT) — transferring healthy gut bacteria from a donor into a patient — can help people with severe alcohol-related liver disease (ALD) who continue to drink and have not been able to stop with conventional addiction treatments. The gut microbiome plays a major role in liver health, and IMT may help by rebalancing gut bacteria, reducing liver inflammation, and potentially reducing cravings for alcohol. You may be eligible if: - You are over 18 years old - You have advanced liver disease caused by alcohol - You continue to drink alcohol - You have previously declined or failed traditional alcohol use disorder treatment - You are able to give informed consent You may NOT be eligible if: - You have recent or current alcoholic hepatitis or alcohol withdrawal symptoms - Your liver disease is very severe (MELD score above 17) - You have uncontrolled mood disorders or primary psychotic conditions - You have current hepatic encephalopathy being treated with lactulose or rifaximin - You are pregnant or breastfeeding - You have serious conditions like chronic inflammatory gut disease (Crohn's, ulcerative colitis), dysphagia, history of bowel obstruction, or a known gut cancer - You have an allergy to capsule ingredients or a history of severe anaphylactic food allergy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntestinal Microbiota Transplant (IMT) Capsules

Capsules containing freeze-dried intestinal microbiota from healthy human donors

DRUGPlacebo Capsules

Capsules containing an inactive substance ("sugar pill")


Locations(2)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

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NCT05548452


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