Home › Alcohol Use Disorder (AUD) › NCT05178069
LGG Supplementation in Patients With AUD and ALD
Lactobacillus Rhamnosus GG: A Novel Probiotic Therapy for Treating Alcohol Use Disorder
Who can join
Ages 21 to 65 · All sexes
Full eligibility 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. 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
About the 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
What is being tested
- : Placebo for Probiotic (drug)
- Lactobacillus Rhamnosus GG (dietary supplement)
Sponsor: University of Louisville · Participants: 60 · Started: Jun 1, 2022
Contact the study team
- Amber Jackson, BS CCRP · Phone: 502-852-2905
- Steve Mahanes · Phone: 502-852-1388
Official record on ClinicalTrials.gov — NCT05178069
Locations in the U.S.
| Kentucky | University of Louisville Hospital, Louisville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.