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LGG Supplementation for Alcohol Use Disorder and Liver Disease

This study is testing if a probiotic called Lactobacillus Rhamnosus GG (LGG) can help people with Alcohol Use Disorder (AUD) and Alcohol-associated Liver Disease (ALD). Researchers want to see if taking LGG for six months can reduce heavy drinking, prevent relapses, and improve liver health. They will compare LGG to a placebo (a capsule without active ingredients). You may be able to join if you are between 21 and 65 years old, have AUD and ALD, and are willing to receive the study treatment. The study aims to understand how LGG might affect the gut and brain, and reduce inflammation. The current status of this study is unclear.

Study design
This interventional study plans to enroll 60 participants to compare Lactobacillus Rhamnosus GG to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes will be measured at 180 days after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05178069

LGG Supplementation in Patients With AUD and ALD

Recruiting
PHASE2Ages 21–65InterventionalTreatment
University of Louisville
~60 participants
Updated 2025-10-31 on ClinicalTrials.gov
What's tested:: Placebo for ProbioticLactobacillus Rhamnosus GG

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
By lowering heavy drinking to meet the criteria on the responder definitions of abstinence, no heavy drinking days, WHO 1-level, and WHO 2-level reduction
Measured over 180 days
+3 more outcomes measured

Conditions

Alcohol Use Disorder
Alcohol-associated Liver Disease

Explore related trials

Alcohol-associated Liver DiseaseAlcoholic HepatitisAlcohol use disorder

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Vatsalya Vatsalya, MD · PRINCIPAL_INVESTIGATOR · Department of Medicine, University of Louisville
  • Craig J McClain, MD · STUDY_CHAIR · Department of Medicine, University of Louisville
  • Harsh Tiwari, MD · STUDY_DIRECTOR · University of Louisville

Who to contact

Amber Jackson, BS CCRP
[email protected]
502-852-2905
Email the study team

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What this trial measures

  • By lowering heavy drinking to meet the criteria on the responder definitions of abstinence, no heavy drinking days, WHO 1-level, and WHO 2-level reduction180 days

    Timeline Followback for past 180 days \[Unit: numerical frequency\], AUDIT \[Unit: numerical frequency\], monthly drinking questionnaire \[Unit: numerical frequency\]).

  • By reducing relapse episodes to minimal/absent incident level180 days

    (Unit: incident frequency).

  • By showing a significant positive effect on one or more of the underlying neurobehavioral domains.180 days

    Questionnaires: reward (reasons for heavy drinking questionnaire or RHDQ \[Unit: numerical frequency\]), craving (Penn Alcohol Craving Scale or PACS, \[Unit: numerical frequency\]; and obsessive compulsive drinking scale or OCDS \[Unit: numerical frequency\]), withdrawal (Clinical Institute Withdrawal Assessment Alcohol Scale Revised \[CIWA-AR\] or CIWA-AR \[Unit: numerical frequency\]), and reinforcement effects (Desires for Alcohol Questionnaire or DAQ \[Unit: numerical frequency\]).

  • By lowering a biochemical marker of alcohol intake180 days

    PeTH (Unit: μmol/L)