Clinical trialNCT05178069RecruitingPhase 2Interventional

LGG Supplementation in Patients With AUD and ALD

SponsorUniversity of LouisvilleEnrollment60Alcohol Use DisorderAlcohol-associated Liver Disease

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

To test the efficacy of 6-month LGG compared to placebo in treating Alcoholic Use Disorder (AUD) and liver injury in Alcoholic Hepatitis (AH). And to evaluate the effects of LGG treatment compared to placebo on therapeutic-mechanistic markers of the gut-brain axis and pro-inflammatory activity in patients with AUD and moderate AH

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Craig J McClain, MD
Department of Medicine, University of Louisville
Study Chair
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Harsh Tiwari, MD
University of Louisville
Study Director
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Vatsalya Vatsalya, MD
Department of Medicine, University of Louisville
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Louisville Hospital
Louisville, Kentucky, United States
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

: Placebo for Probiotic

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Jun 2022
Primary completion: 31 Aug 2026
Completion: 28 Feb 2027
Last update posted: 31 Oct 2025
Registered enrollment: 60
Registry id: NCT05178069

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.