Back to search results

Protein Supplement for Hepatic Encephalopathy Readmissions

This study is looking at whether a protein supplement called Ensure Enlive can help reduce hospital readmissions for people with hepatic encephalopathy (a brain condition caused by liver disease). If you are between 18 and 75 years old, have cirrhosis (scarring of the liver), and have been hospitalized for hepatic encephalopathy at least once in the last year, you might be able to join. The study aims to see if taking Ensure Enlive twice a day for 180 days can lower readmission rates compared to standard care. The study plans to enroll 40 participants.

Study design
This is a randomized study, meaning participants will be assigned by chance to either receive the Ensure Enlive supplement or standard care. It plans to include 40 participants.
What's involved
Participants in the intervention group will take two Ensure Enlive supplements per day for 180 days. The study will measure readmission rates at the beginning and end of this period.
Compensation
Not stated in the trial record.
Follow-up
The study measures readmission rates at Day 0 and Day 180, indicating a follow-up period of 180 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04096014

Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy

Recruiting
NAAges 18–75InterventionalPrevention
The Cleveland Clinic
~40 participants
Updated 2025-11-25 on ClinicalTrials.gov
What's tested:Ensure EnliveStandard Of Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine if decreasing nocturnal fasting by protein supplements will change readmission rates.
Measured over Day 0 & Day 180

Conditions

Hepatic Encephalopathy

Explore related trials

CirrhosisHepatic Encephalopathy

Where it's being run

1 sites across 1 states
Ohio1

Who to contact

Annette C Bellar
[email protected]
2166365247 · ext. 2166365247
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

\> 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

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.

What this trial measures

  • Determine if decreasing nocturnal fasting by protein supplements will change readmission rates.Day 0 & Day 180

    Change in number of readmissions