What side effects are associated with this type of intervention?

Common treatments for Alcoholic Hepatitis include nutritional supplements aimed at enhancing muscle strength and gut health. These treatments may include protein- and energy-dense supplements, omega-3 fatty acids, and other nutritional interventions. Known side effects of these treatments can include gastrointestinal discomfort, nausea, and potential allergic reactions. Additionally, omega-3 fatty acids may cause mild side effects such as a fishy aftertaste, belching, and indigestion. It is important to monitor liver function and overall health during treatment, especially in patients with pre-existing liver conditions.

What prior FDA approvals exist?

There are currently no FDA-approved medications specifically for the treatment of Alcoholic Hepatitis. Management typically involves supportive care, including nutritional support and abstinence from alcohol. The trial mentioned involves a nutritional supplement aimed at enhancing muscle strength and gut health, which aligns with the general approach of improving overall health and nutritional status in patients with Alcoholic Hepatitis. This approach is consistent with the broader strategy of using nutritional interventions to support recovery in these patients.

What other types of research exist?

Promising novel alternatives for enhancing muscle strength and gut health in alcoholic hepatitis patients include branched-chain amino acid (BCAA) supplementation, which has shown improvements in nutritional status, prognosis, and quality of life in liver cirrhosis patients. Additionally, emerging treatments for sarcopenia in chronic liver disease, such as rational nutritional interventions, appropriate physical exercise, effective ammonia-lowering strategies, hormone supplements, and targeted molecular therapies (e.g., myostatin blockers), may also be beneficial.

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Sodium Hyaluronate for Alcoholic Hepatitis

Q: What is the mechanism of action of this treatment?

Common treatments for Alcoholic Hepatitis (AH) often focus on reducing liver inflammation, improving liver function, and addressing nutritional deficiencies. Nutritional supplements, such as those enhancing muscle strength and gut health, play a crucial role. These supplements may contain branched-chain amino acids, which help in muscle protein synthesis and reduce muscle wasting, and probiotics or prebiotics, which improve gut barrier function and reduce systemic inflammation. This is particularly important for AH patients, as muscle wasting and gut permeability are common complications that exacerbate liver disease. By addressing these issues, such treatments can improve overall patient outcomes and quality of life.

Phase < 1

Recruiting

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Must not have

Inability to provide consent

Acute or chronic liver disease due to other active causes, in addition to alcoholic liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial involves patients taking a special treatment called HA35 for several months. The goal is to see if HA35 improves health markers like muscle strength and body composition. Participants will undergo various tests to measure these effects.

Who is the study for?

This trial is for adults who've been drinking heavily (over 60g/day for men, over 40g/day for women) and have moderate alcoholic hepatitis but not severe liver damage or other serious health issues. Pregnant women, those with recent surgeries, kidney failure, certain blood disorders, active infections or cancers can't participate.

What is being tested?

Participants will take either Sodium Hyaluronate or a placebo capsule daily for 90 days to see if it helps with alcoholic hepatitis. They'll have two in-person visits with exams and tests plus phone check-ins. A muscle biopsy and gut permeability test are also part of the study.

What are the potential side effects?

While specific side effects aren't listed here, participants may experience discomfort from procedures like muscle biopsies and potential unknown side effects from Sodium Hyaluronate or the placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with alcoholic hepatitis, meet the alcohol intake criteria, and my liver function tests match the specified levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give consent myself.

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I have liver disease not only from alcohol.

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I have a muscle disease.

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I have experienced severe confusion due to liver problems.

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I am not taking drugs that affect muscle growth or breakdown.

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I had surgery on my upper stomach area in the last 6 months.

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I have not had gastrointestinal bleeding in the last 2 weeks.

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I have had an organ or bone marrow transplant.

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I am taking medication that affects blood clotting.

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I have swelling in my feet.

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I do not have any end-stage organ diseases.

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I have been diagnosed with cancer.

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I have kidney failure or am on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: HA35 Treatment GroupActive Control1 Intervention

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.

Group II: HA35 Placebo GroupPlacebo Group1 Intervention

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.

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alcoholic Hepatitis (AH) often focus on reducing liver inflammation, improving liver function, and addressing nutritional deficiencies. Nutritional supplements, such as those enhancing muscle strength and gut health, play a crucial role. These supplements may contain branched-chain amino acids, which help in muscle protein synthesis and reduce muscle wasting, and probiotics or prebiotics, which improve gut barrier function and reduce systemic inflammation. This is particularly important for AH patients, as muscle wasting and gut permeability are common complications that exacerbate liver disease. By addressing these issues, such treatments can improve overall patient outcomes and quality of life.

Agomelatine for the treatment of generalized anxiety disorder.Branched-chain amino acid supplementation in adults with cirrhosis and porto-systemic encephalopathy: systematic review.