Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy (NCT04096014)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (10 items).
Location: Cleveland Clinic Foundation — Cleveland, Ohio
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Cleveland Clinic Foundation — Cleveland, Ohio
📞 Contact the Study Coordinator
Phone: (216) 636-5247
Email: bellara@ccf.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hepatic Encephalopathy
- Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis — Homewood, Alabama
- Revealing Engagement Patterns Among Hepatic Encephalopathy Patients — San Francisco, California
- Affect of Melatonin on Sleep and Cognition in Cirrhosis — New York, New York
- Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis — Dothan, Alabama
- Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy — Rochester, Minnesota
Explore by condition: All Hepatic Encephalopathy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.