Recruiting
Phase 2

LGG with AUD

Sponsor:

University of Louisville

Code:

NCT05178069

Conditions

Alcohol Use Disorder

Alcohol-associated Liver Disease

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

: Placebo for Probiotic

Lactobacillus Rhamnosus GG

Study Details

Brief 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

Alcohol Use Disorder

Alcohol-associated Liver Disease

Study ID

NCT05178069

Start date

Jun 1, 2022

Status verified date

Oct, 2025

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Breath alcohol concentration (BAC) equal to 0.00 when the participant signs the informed consent document.
2. Age between 21 and 65 years old (inclusive).
3. Willingness to receive trial treatment.
4. Ability to provide informed consent
5. Understanding that this is not an alcohol treatment study.
6. Heavy drinking. Men must consume ≥ 20 and women ≥ 14 standardized alcoholic beverages a week for the past 3 months.
7. Diagnosis of Alcohol Use Disorder using DSM V criteria.
8. 50 <AST<400 U/L; AST > ALT; and ALT < 200 U/L; total bilirubin > 1.2 mg/dL
9. Model for End-Stage Liver Disease: 8 ≤ (MELD) ≤19.
10. Good health as confirmed by medical history, physical examination, ECG, laboratory tests and vital signs except for liver injury and AUD related history.
11. Provide contact information for someone who may be able to contact the subject in case of a missed appointment.
12. . Females of child-bearing potential must not be pregnant and must be using birth control

Exclusion Criteria:

1. Current (last 12 months) DSM V diagnosis of dependence on any psychoactive substance other than alcohol or nicotine,
2. Positive urine drug screen at baseline for any illegal substance other than marijuana,
3. History of hospitalization for alcohol intoxication delirium, alcohol withdrawal delirium or seizure,
4. Participation in any research study for alcoholism treatment within 3 months prior to signing the informed consent,
5. Pharmacological treatment with naltrexone, acamprosate, topiramate, or disulfiram within 1 month prior to randomization,
6. Lifetime diagnosis based on DSM-V criteria of schizophrenia, bipolar disorder, or other psychosis, eating disorders; current or past year diagnosis of major depression
7. In the investigators' opinion, moderate to severe risk of suicide (e.g., active plan, or recent attempt in last 6 months),
8. Current use of psychotropic medications that cannot be discontinued,
9. Clinically significant medical abnormalities (apart from moderate ALD, MELD≤19),
10. Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) >10, at screening for more than 3 days,
11. Serious medical diseases, such as cancer, liver cirrhosis, pancreatitis, severe alcohol associated hepatitis, heart chronic failure, chronic kidney failure, chronic intestinal diseases (e.g., Crohn's disease), chronic neurological disorders (e.g., tardive dyskinesia, epilepsy, Parkinson's disease)
12. History of clinically significant hypotension (e.g., history of lipotimia and/or syncopal episodes)
13. History of adverse reactions to needle puncture,
14. Obesity (BMI ≥ 33.0 kg/m2),
15. Pregnancy; incarceration; inability to provide consent
16. Signs of systemic infection: Fever > 38o C, positive blood or ascites cultures, on appropriate antibiotic therapy for > 3 days within 3 days of inclusion
17. Acute gastrointestinal bleeding requiring > 2 units blood transfusion within the previous 2 weeks
18. Undue risk from immunosuppression: Positive HBsAg; positive skin PPD skin test or history of treatment for tuberculosis; known HIV infection

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo Comparator: Placebo for Probiotic

Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.

active comparator: Active Comparator: Lactobacillus Rhamnosus GG

Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.

Interventions

: Placebo for Probiotic

Capsule manufactured without active ingredients.

Lactobacillus Rhamnosus GG

Probiotic nutritional supplement; Lactobacillus Rhamnosus G

Primary outcome measure

  • 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 [ Time Frame: 180 days ]
  • By reducing relapse episodes to minimal/absent incident level [ Time Frame: 180 days ]
  • By showing a significant positive effect on one or more of the underlying neurobehavioral domains. [ Time Frame: 180 days ]
  • By lowering a biochemical marker of alcohol intake [ Time Frame: 180 days ]

Central Contacts and Locations

Locations

University of Louisville Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Vatsalya Vatsalya, MD, PgD, MSc, MS, FRSM

502-952-8928v0vats01@louisville.edu

More Information

Sponsor

University of Louisville

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

  • AUD
  • ALD
  • AH
  • TLFB
  • LTDH
  • AUDIT
  • WHO Drinking Level Reduction Criteria
  • MELD
  • ALT
  • AST
  • ABIC
  • Total Bilirubin
  • Heavy Drinking
  • Drinking Pattern
  • AUD Domains
  • Albumin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2025-10-31.