RecruitingAlcohol Use DisorderAlcohol-associated Liver Disease
LGG Supplementation in Patients With AUD and ALD
Eligible age
21–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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
Sponsor: University of Louisville
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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,
Where it's recruiting
Kentucky
Louisville
Source: ClinicalTrials.gov · NCT05178069 · last updated 2025-10-31