Hepatic EncephalopathyNCT04096014
Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
A study testing Ensure Enlive in people with Hepatic Encephalopathy, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- Ensure Enlive
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2019to 30 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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
Show all 9Show fewer
- recent gastrointestinal surgery within past 12 months
- ongoing infection (positive blood or other body fluid cultures)
- active gastrointestinal bleeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Annette Bellar, BS, 216-445-6268, bellara@ccf.org
Revathi Penumatsa, penumar@ccf.org
About this study
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.
- Conditions
- Hepatic Encephalopathy
- Being tested
- Ensure Enlive, Standard Of Care
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensure EnliveDietary supplement
The subjects in the intervention group will receive two Ensure Enlive supplements per day for 180 days.
Standard Of CareOther
The subjects in the Standard of care group will continue to receive the standard clinical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Ensure Enlive | Active comparator | Not described Receives: Dietary Supplement: Ensure Enlive; Other: Standard Of Care |
| Standard of Care | Placebo comparator | Not described Receives: Other: Standard Of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if decreasing nocturnal fasting by protein supplements will change readmission rates.
Change in number of readmissions
Measured: Day 0 & Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start16 Sep 2019
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinivasan Dasarathy, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096014
- Sponsor's protocol ID
- 18-749
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2019
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT04096014
- Acronym / sponsor ID
- 18-749
- Conditions
- Hepatic Encephalopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ensure Enlive | Active comparator | Dietary Supplement: Ensure Enlive, Other: Standard Of Care |
| Standard of Care | Placebo comparator | Other: Standard Of Care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ensure EnliveThe subjects in the intervention group will receive two Ensure Enlive supplements per day for 180 days. | Dietary supplement | Ensure Enlive |
| Standard Of CareThe subjects in the Standard of care group will continue to receive the standard clinical therapy. | Other | Ensure Enlive, Standard of Care |
Primary outcome
Determine if decreasing nocturnal fasting by protein supplements will change readmission rates.
Time frame: Day 0 & Day 180
Change in number of readmissions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure Enlive in people with Hepatic Encephalopathy, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annette C Bellar (2166365247 ext. 2166365247, bellara@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if decreasing nocturnal fasting by protein supplements will change readmission rates. (time frame: Day 0 & Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.