Testing LGG for Alcohol Use Disorder and Liver Injury

Lactobacillus Rhamnosus GG: A Novel Probiotic Therapy for Treating Alcohol Use Disorder

This study is testing if a probiotic called LGG can help people with Alcohol Use Disorder and liver issues drink less and improve their liver health over six months.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: University of Louisville (Academic / other)
• Locations: 1 site (Louisville, Kentucky)
• Trial ID: NCT05178069 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy of Lactobacillus Rhamnosus GG (LGG) supplementation over six months compared to a placebo in patients with Alcohol Use Disorder (AUD) and moderate Alcoholic Hepatitis (AH). The study will assess the impact of LGG on reducing heavy drinking, relapse episodes, and biochemical markers of alcohol intake, as well as improving liver function and overall health outcomes. Additionally, it will explore the effects of LGG on gut-brain axis markers and pro-inflammatory activity in these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 65 with a diagnosis of Alcohol Use Disorder and moderate liver injury.

Not a fit: Patients with severe liver disease or those not meeting the heavy drinking criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with AUD and liver injury.

How similar studies have performed: While the approach of using probiotics in AUD is emerging, this specific application of LGG in conjunction with liver injury is relatively novel.

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

Where this trial is running

Louisville, Kentucky

• University of Louisville Hospital — Louisville, Kentucky, United States (Recruiting)

Study contacts

• Principal investigator: Vatsalya Vatsalya, MD — Department of Medicine, University of Louisville
• Study coordinator: Amber Jackson, BS CCRP

Conditions Alcohol Use Disorder; Alcohol-associated Liver Disease; AUD; ALD; AH; TLFB; LTDH; AUDIT