Intestinal Microbiota Transplant in Alcohol-Associated Chronic Liver Disease and Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Virginia Commonwealth University
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: -\>18 years of age * Advanced liver disease * Able to give written, informed consent * Alcohol as a cause of advanced liver disease * Continued sustained drinking * Having previously declined a referral to traditional AUD therapy services or having failed such treatments Exclusion Criteria: * Lack of sustained drinking * Recent or current alcoholic hepatitis * Alcohol withdrawal symptoms * Clinically significant use of illicit drugs * Uncontrolled mood disorders or primary psychotic conditions * MELD score\>17 * Unclear diagnosis of chronic liver disease * Current hepat…
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 CenterRichmond, Virginia
- Virginia Commonwealth UniversityRichmond, Virginia