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LGG Supplementation in Patients With AUD and ALD

NCT05178069 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-31

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

: Placebo for Probiotic

Capsule manufactured without active ingredients.

DIETARY_SUPPLEMENT

Lactobacillus Rhamnosus GG

Probiotic nutritional supplement; Lactobacillus Rhamnosus G

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • University of Louisville

    lead OTHER

Principal Investigators

  • Vatsalya Vatsalya, MD · Department of Medicine, University of Louisville

  • Craig J McClain, MD · Department of Medicine, University of Louisville

  • Harsh Tiwari, MD · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2026-08-31
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05178069 on ClinicalTrials.gov