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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HA35 Placebo Group | Placebo Comparator | 24 study participants will receive the standard of care treatment for AH and a 90-day supply of a placebo to take once a day with breakfast. |
|
| HA35 Treatment Group | Active Comparator | 24 study participants will receive the standard of care treatment for AH and a 90-day supply of a HA35 to take once a day with breakfast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Hyaluronate | Drug | Sodium hyaluronate of molecular weight 35kDa will be given in capsule form to study participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare percent change of skeletal muscle mass | Baseline to 90 days |
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Inclusion Criteria:
• Clinical diagnosis of alcoholic hepatitis defined as:
AND
OR Histologic evidence of AH.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Srinivasan Dasarathy, MD | Contact | 216-318-7010 | dasaras@ccf.org | |
| Annette Bellar | Contact | bellara@ccf.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41494657 | Derived | Welch N, Kannan P, Davuluri G, Bellar A, Attaway AH, Mishra S, Cunningham JA, Kumar A, Musich R, Ertugral EG, Agrawal V, Hsu IL, Harford TJ, Weisleder NL, Vachharajani VT, Kothapalli CR, de la Motte CA, Nagy LE, Dasarathy S. Hyaluronan 35 prevents endotoxin-mediated dysregulated skeletal muscle proteostasis during ethanol exposure. Am J Physiol Endocrinol Metab. 2026 Feb 1;330(2):E212-E232. doi: 10.1152/ajpendo.00283.2025. Epub 2026 Jan 6. |
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| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Placebo | Drug | A placebo will be given in capsule form to study participants |
|
| D020751 |
| Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |