Lactobacillus Rhamnosus GG: A Novel Probiotic Therapy for Treating Alcohol Use Disorder
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
• Breath alcohol concentration (BAC) equal to 0.00 when the participant signs the informed consent document.
• 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 must consume ≥ 20 and women ≥ 14 standardized alcoholic beverages a week for the past 3 months.
• Diagnosis of Alcohol Use Disorder using DSM V criteria.
• 50 \<AST\<400 U/L; AST \> ALT; and ALT \< 200 U/L; total bilirubin \> 1.2 mg/dL
• Model for End-Stage Liver Disease: 8 ≤ (MELD) ≤19.
⁃ Good health as confirmed by medical history, physical examination, ECG, laboratory tests and vital signs except for liver injury and AUD related history.
⁃ Provide contact information for someone who may be able to contact the subject in case of a missed appointment.
⁃ . Females of child-bearing potential must not be pregnant and must be using birth control