Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Location status: Recruiting
Location contact
Annette Bellar, BS
CONTACT
Revathi Penumatsa
CONTACT
Srinivasan Dasarathy, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04096014
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
Location status: Recruiting
Annette Bellar, BS
CONTACT
Revathi Penumatsa
CONTACT
Srinivasan Dasarathy, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The subjects in the intervention group will receive two Ensure Enlive supplements per day for 180 days.
The subjects in the Standard of care group will continue to receive the standard clinical therapy.
Time frame: Day 0 & Day 180
Change in number of readmissions
Contact information is provided by the study sponsor or research team.
The Cleveland Clinic
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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