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RecruitingPhase 1, Phase 2NCT05548452

Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease

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Trial Parameters

ConditionLiver Disease; Alcohol-Related
SponsorVirginia Commonwealth University
Study TypeINTERVENTIONAL
PhasePhase 1, Phase 2
Enrollment80
SexALL
Min Age18 Years
Max AgeN/A
Start Date2022-11-21
Completion2026-11-30
Interventions
Intestinal Microbiota Transplant (IMT) CapsulesPlacebo Capsules

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Brief 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 Criteria

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 hepatic encephalopathy on lactulose and/or rifaximin * WBC count\<1000 * Non-elective hospitalization within last month * on dialysis * known untreated, in-situ luminal GI cancers * chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease or microscopic colitis, eosinophilic gastroenteritis and celiac disease) * Dysphagia within 2 weeks * History of aspiration, gastroparesis, intestinal obstructi

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