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: Review the eligibility criteria below.
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 ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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
- Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis — Dothan, Alabama
- Fecal Microbiota Transplant as Treatment of Hepatic Encephalopathy — Boston, Massachusetts
- Revealing Engagement Patterns Among Hepatic Encephalopathy Patients — San Francisco, California
- Endoscopic Shunts Embolization for Refractory Hepatic Encephalopathy — Newark, New Jersey
- Microbiota trAnSplant ThERaPy In hEpatiC Encephalopathy (MASTERPIECE) — West Haven, Connecticut
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.