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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 & day 180
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
1,020 Previous Clinical Trials
1,365,638 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people sign up for this experiment now?

"This clinical trial, as detailed on the website clinicaltrials.gov, is looking for patients right now. The study was originally posted on September 16th, 2019 and updated August 30th, 2020."

Answered by AI

How can I become a subject in this research project?

"Up to 40 patients that have hepatic coma and meet the age criteria of 18-75 years old can participate. Key inclusion requirements are as follows: being >18 years old and having had an abdominal CT scan at any point in the past."

Answered by AI

Does age limit a person's ability to participate in this research?

"The age range for individuals eligible to participate in this trial is between 18 and 75 years old."

Answered by AI

How many volunteers are enrolled in this experiment?

"That is correct, the online information does show that the research team is still enrolling people for this study. The original posting date was September 16th, 2019 with the latest update happening on August 30th, 2022. They are hoping to have 40 individuals sign up from 1 location."

Answered by AI
~2 spots leftby Jun 2024