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Dietary Supplement

Nutritional Supplement for Hepatic Encephalopathy

N/A
Recruiting
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cirrhosis diagnosed by clinical history and liver biopsy and/or clinical, biochemical and imaging evidence of cirrhosis
18 years of age
Must not have
Active gastrointestinal bleeding
Uncontrolled diabetes mellitus with A1c>9.5 (to avoid altered muscle protein metabolism)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 & day 180

Summary

This trial looks at whether a nutritional intervention can help reduce the rates of hepatic encephalopathy and consequent readmission for patients with end stage liver disease.

Who is the study for?
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.
What is being tested?
The study tests if taking Ensure Enlive protein supplement late at night and early morning can reduce hospital readmissions due to hepatic encephalopathy in cirrhotic patients. It's a randomized trial comparing this nutritional intervention against standard care over six months.
What are the potential side effects?
Ensure Enlive is generally safe but may cause digestive discomfort like gas or bloating. In some cases, it could lead to an imbalance of nutrients if not used as directed under medical supervision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with cirrhosis through tests or my medical history.
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I am 18 years old or older.
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I was hospitalized for HE within the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently experiencing bleeding in my digestive tract.
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My diabetes is not under control, with an A1c level over 9.5.
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My kidney function is impaired, shown by high creatinine levels not improved with treatment.
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I currently have cancer.
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My organs are failing and I need support to keep them working.
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I am not taking steroids that affect muscle mass.
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I have had surgery on my digestive system in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 & day 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 & day 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine if decreasing nocturnal fasting by protein supplements will change readmission rates.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Ensure EnliveActive Control2 Interventions
Group II: Standard of CarePlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,057 Previous Clinical Trials
1,371,720 Total Patients Enrolled

Media Library

Ensure Enlive (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04096014 — N/A
Encephalopathy Research Study Groups: Ensure Enlive, Standard of Care
Encephalopathy Clinical Trial 2023: Ensure Enlive Highlights & Side Effects. Trial Name: NCT04096014 — N/A
Ensure Enlive (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04096014 — N/A
~9 spots leftby Jun 2026
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