Mechanism of HA35 in Patients With Alcoholic Liver Disease
Eligible participants will be asked to take a placebo/treatment capsule for 90 days and participate in two in-person study visits, one at the start of the 90 days and the second at the completion of study supplement administration. Both visits will include a physical exam, clinical labs, body composition measurements, muscle strength tests, questionnaires, and urine and stool collections. Additionally, a sugar cocktail will be consumed to measure gut permeability and a muscle biopsy will be collected. The day after the visits, you will need to return to drop off the 24-hour urine collection. Two phone visits will be performed in between the in-person visits at day 30 and 60 where you will be asked a series of questionnaires as well as asked about study supplement compliance.
⁃ • Clinical diagnosis of alcoholic hepatitis defined as:
• Regular consumption of alcohol with an intake of \>60 g daily or \>420 g weekly on average for men and \>40 g daily or \>280 g weekly on average for women for 6 months or more
⁃ AND
• MELD \<21
• Serum total bilirubin \>3 mg/dL
• AST \>50 IU/I; AST:ALT ratio \>1.5; Both AST and ALT \<400 IU/I
⁃ OR Histologic evidence of AH.