NCT05178069 LGG Supplementation in Patients With AUD and ALD
| NCT ID | NCT05178069 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Louisville |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2022-06-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Vatsalya Vatsalya, MD
PRINCIPAL INVESTIGATOR
Department of Medicine, University of Louisville
Frequently Asked Questions
Who can join the NCT05178069 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05178069 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05178069 currently recruiting?
Yes, NCT05178069 is actively recruiting participants. Contact the research team at amber.jackson.1@louisville.edu for enrollment information.
Where is the NCT05178069 trial being conducted?
This trial is being conducted at Louisville, United States.
Who is sponsoring the NCT05178069 clinical trial?
NCT05178069 is sponsored by University of Louisville. The principal investigator is Vatsalya Vatsalya, MD at Department of Medicine, University of Louisville. The trial plans to enroll 60 participants.