HA35 Moderate Alcoholic Hepatitis (AH) Study

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.

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

Conditions2

Interventions1

Locations1 site

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