Actively Recruiting
LGG Supplementation in Patients With AUD and ALD
Led by University of Louisville · Updated on 2025-10-31
60
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
U
University of Louisville
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
LGG Supplementation in Patients With AUD and ALD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Breath alcohol concentration (BAC) equal to 0.00 when signing consent
- Age between 21 and 65 years old (inclusive)
- Willingness to receive trial treatment
- Ability to provide informed consent
- Understanding that this is not an alcohol treatment study
- Heavy drinking: men 6 20 and women 6 14 standard alcoholic drinks per week for past 3 months
- Diagnosis of Alcohol Use Disorder using DSM V criteria
- AST between 50 and 400 U/L; AST greater than ALT; ALT less than 200 U/L; total bilirubin above 1.2 mg/dL
- Model for End-Stage Liver Disease (MELD) score between 8 and 19
- Good health except for liver injury and AUD history, confirmed by history, exam, ECG, labs, vitals
- Provide contact for someone who can reach participant if missed appointment
- Females of child-bearing potential must not be pregnant and must use birth control
You will not qualify if you...
- Dependence on any psychoactive substance other than alcohol or nicotine in last 12 months
- Positive urine drug screen for illegal substances other than marijuana at baseline
- History of hospitalization for alcohol intoxication delirium, withdrawal delirium or seizure
- Participation in alcoholism treatment research within 3 months prior to consent
- Use of naltrexone, acamprosate, topiramate, or disulfiram within 1 month prior to randomization
- Lifetime diagnosis of schizophrenia, bipolar disorder, psychosis, eating disorders; major depression in past year
- Moderate to severe suicide risk in last 6 months
- Use of psychotropic medications that cannot be stopped
- Significant medical abnormalities except moderate ALD with MELD 19
- Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) score over 10 for more than 3 days at screening
- Serious diseases like cancer, liver cirrhosis, pancreatitis, severe AH, heart or kidney failure, chronic intestinal or neurological disorders
- History of clinically significant hypotension or adverse reactions to needle puncture
- Obesity with BMI 6 33.0 kg/m2
- Pregnancy, incarceration, or inability to provide consent
- Signs of systemic infection or acute gastrointestinal bleeding requiring transfusion in past 2 weeks
- Immunosuppression risks such as positive Hepatitis B surface antigen, tuberculosis, or HIV infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
A
Amber Jackson, BS CCRP
CONTACT
S
Steve Mahanes
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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