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Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy

Sponsor: The Cleveland Clinic • ClinicalTrials.gov ID: NCT04096014

Registry updated: 2026-09-25

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Description

Readmission rates for patients with hepatic encephalopathy due to end stage liver disease are high. Hyperammonemia contributes significantly to encephalopathy and occurs because of impaired hepatic ureagenesis and increased skeletal muscle proteolysis. We propose a randomized, 6-month nutritional intervention in cirrhotic patients who have had at least 1 admission for hepatic encephalopathy within the last 6 months. We hypothesize that a combination of late evening and early morning protein supplement (Ensure Enlive) will decrease recurrent hepatic encephalopathy and consequent readmission rates by lowering skeletal muscle proteolysis and improved lean body mass.

Interventions

Ensure Enlive (Dietary supplement)
The subjects in the intervention group will receive two Ensure Enlive supplements per day for 180 days.
Standard Of Care (Other)
The subjects in the Standard of care group will continue to receive the standard clinical therapy.

Eligibility criteria

Inclusion Criteria: * \> 18 years of age * cirrhosis diagnosed by clinical history and liver biopsy and/or clinical, biochemical and imaging evidence of cirrhosis * at least 1 hospitalization for documented HE within the last 12 months. * abdominal CT scan anytime in the past Exclusion Criteria: * Patients with MELD score \> 35 * end stage organ failure (major dysfunction requiring organ support) * kidney injury defined by a creatinine \> 2 mg/dl or rise in creatinine by 0.5 gm/dl from baseline that is unresponsive to withholding diuretics and intravenous albumin administration (1 gm/kg up to 100 gm/day) * active malignancy * uncontrolled diabetes mellitus with A1c\>9.5 (to avoid altered muscle protein metabolism * medications (anabolic steroids, corticosteroids) that affect skeletal muscle mass * recent gastrointestinal surgery within past 12 months * ongoing infection (positive blood or other body fluid cultures) * active gastrointestinal bleeding.

Conditions

Hepatic Encephalopathy

Locations

Cleveland Clinic Foundation — Cleveland, Ohio, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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