Mechanism of HA35 in Patients With Alcoholic Liver Disease
The Cleveland Clinic
Summary
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.
Description
Written informed consent will be obtained during the baseline visit (day 1). Patients will given a physical exam and a blood test will be obtained if not in their medical chart. The subjects who meet the criteria after the screening visit will have the following procedures: A. Body composition will be quantified by whole-body dual energy X-ray absorptiometry (DEXA), Bioelectric Impedance Analysis (BIA), chair stands, 3 position balance and hand grip strength by dynamometry. B. Muscle biopsy from the lateral portion of vastus lateralis, about 20 cm above knee, C. Questionnaires, D. Blood collec…
Eligibility
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: • 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. Exclusion Criteria: * Pregnant or breastfeeding women * Patients with gastrointestinal bleeding within 2 weeks * Active infection (positive blood or ascitic fluid culture) * Overt encephalopath…
Interventions
- DrugSodium Hyaluronate
Sodium hyaluronate of molecular weight 35kDa will be given in capsule form to study participants
- DrugPlacebo
A placebo will be given in capsule form to study participants
Location
- Cleveland ClinicCleveland, Ohio