HA35 Moderate Alcoholic Hepatitis (AH) Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 collection, E. Collection of stool samples, F. Sugar cocktail administration, and G. Urine collection (24 hour) After baseline measures have been completed, patients will be randomized in a 1:1 ratio to either standard of care (SOC) + HA35 or SOC + placebo (140 mg/d) for a total of 3 months post enrollment. The subjects will be recalled after 3 months. The visit and the procedures conducted on day 90 will be similar to the baseline study visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05018481
Study type	Interventional
Source	The Cleveland Clinic
Contact	Srinivasan Dasarathy, MD
Phone	216-318-7010
Email	dasaras@ccf.org
Status	Recruiting
Phase	Early Phase 1
Start date	September 1, 2022
Completion date	October 1, 2025

View Details

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