LGG Supplementation in Patients With AUD and ALD

• Status: Not yet recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Louisville
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Criteria

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. 50ALT; and ALT < 200 U/L; total bilirubin > 1.2 mg/dL

9. Model for End-Stage Liver Disease: 12 ≤ (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