Alcoholic Hepatitis Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 54 |
Est. completion date | October 1, 2026 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | 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 encephalopathy - Renal failure and/or on dialysis - Medications that alter muscle protein metabolism - Myopathies - Other end-stage organ diseases - Malignancy - Solid organ or hematopoietic transplantation - Active alcohol withdrawal or ongoing participation in a Clinical Institute Withdrawal Assessment (CIWA) protocol - History of recent upper gastrointestinal resection within past 6 months - Acute or chronic liver disease due to other active causes, in addition to alcoholic liver disease - Inability to provide consent - Creatinine >2mg/dL - Platelets <60,000k/ul - PT/INR >1.7 - Presence of pedal edema - Use of anti-platelet/anticoagulation drugs or medications that interfere with blood clotting |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare percent change of skeletal muscle mass | Baseline to 90 days |
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