Nutritional Supplement for Hepatic Encephalopathy
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop your current medications, but you cannot participate if you are taking anabolic steroids or corticosteroids.
What data supports the idea that Nutritional Supplement for Hepatic Encephalopathy is an effective treatment?
The available research does not provide specific data on the effectiveness of Nutritional Supplement for Hepatic Encephalopathy. The studies focus on enteral nutrition for other conditions like intracerebral hemorrhage and head injuries, but they do not directly address hepatic encephalopathy. Therefore, there is no direct evidence from the provided information to support the effectiveness of this treatment for hepatic encephalopathy.12345
What safety data exists for the nutritional supplement used in hepatic encephalopathy treatment?
The safety of L-ornithine-L-aspartate (LOLA) has been evaluated in clinical trials, including a randomized, double-blind, placebo-controlled trial and an open-label, prospective, multicentre observational study. These studies assessed its safety in controlling minimal hepatic encephalopathy and improving health-related quality of life in cirrhotic patients. Additionally, a pilot study tested the safety and tolerability of the probiotic Bacillus subtilis HU58 in patients with hepatic encephalopathy. These studies provide evidence of safety for these treatments in the context of hepatic encephalopathy.678910
Is Ensure Enlive a promising treatment for hepatic encephalopathy?
The research articles provided do not specifically mention Ensure Enlive as a treatment for hepatic encephalopathy. They discuss other treatments like oral L-ornithine-L-aspartate, L-carnitine, lactulose, probiotics, and Bifidobacterium with fructo-oligosaccharides. Therefore, there is no direct evidence from these articles to suggest that Ensure Enlive is a promising treatment for hepatic encephalopathy.611121314
Research Team
Eligibility Criteria
This trial is for adults with cirrhosis who've been hospitalized for hepatic encephalopathy in the last year. They must have a diagnosis confirmed by clinical history, liver biopsy, or imaging and not be severely ill (MELD score ≤ 35), have uncontrolled diabetes (A1c ≤ 9.5), recent GI bleeding or surgery, active cancer, significant kidney injury, end-stage organ failure, or be on muscle-affecting drugs.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 6-month nutritional intervention with late evening and early morning protein supplements
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ensure Enlive (Dietary Supplement)
Ensure Enlive is already approved in Canada for the following indications:
- Nutritional support for patients with malnutrition, including those with liver disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor