Protein supplement to reduce hospital readmissions for liver disease patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of a nutritional intervention using a protein supplement called Ensure Enlive on patients with hepatic encephalopathy due to cirrhosis. The study aims to reduce readmission rates by administering the supplement in late evening and early morning to improve lean body mass and decrease skeletal muscle proteolysis. Participants will be monitored over a 6-month period to assess the impact of this intervention on recurrent hepatic encephalopathy. The trial includes patients who have had at least one hospitalization for hepatic encephalopathy in the past year.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Annette C Bellar
• Email: bellara@ccf.org
• Phone: 2166365247

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Examining the link between serum albumin levels and hepatic encephalopathy severity in chronic liver disease patients

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.