Minimal Hepatic EncephalopathyNCT01083446
A Nutritional Approach to Minimal Hepatic Encephalopathy
A study testing Nutritional Intervention in people with Minimal Hepatic Encephalopathy, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
This trial will study a possible effect of standard Israeli breakfast (30% of caloric value and 21 gram protein) on cognitive and executive functions (working memory, visual memory, concentration and coordination), on patients with mild-moderate liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minimal Hepatic Encephalopathy
- What is being tested?
- Nutritional Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2008to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consented adults (age > 18), with the diagnosis of CHILD A cirrhosis with MELD score of < 10.
- Diagnosis of liver cirrhosis as documented by liver biopsy (stage IV) and / or fibroscan (score > 12 kpa) and / or fibrotest (score > 0.74) and /or imaging.
Who cannot join
- History of > grade II hepatic encephalopathy (HE).
- Diagnosis of dementia, Parkinson disease, Schizophrenia (Patients with major depression will be noted but not excluded).
- Use of sedatives, tranquilizers or anti- psychotic medication during and/or 2 weeks prior to enrolling Use of antibiotics for any length of period during and/or 2 weeks prior to enrolling.
- Current use of lactulose or neomycin.
- Use of alcohol or elicit drugs during and/ or 6 months prior to enrolling.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Nachum Vaisman, Prof', +972-3-6974807, vaisman@tasmc.health.gov.il
About this study
This trial will study a possible effect of standard Israeli breakfast (30% of caloric value and 21 gram protein) on cognitive and executive functions (working memory, visual memory, concentration and coordination), on patients with mild-moderate liver cirrhosis.
- Conditions
- Minimal Hepatic Encephalopathy
- Being tested
- Nutritional Intervention
- Keywords
- Encephalopathy, Cirrhotics
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional InterventionOther
Cognitive and executive functions before and after standard israeli breakfast (30% of caloric value and 21 gram protein)
Nutritional InterventionOther
Cognitive and executive functions during fast
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Nutritional intervention, standard Israeli breakfast Receives: Other: Nutritional Intervention |
| B | Active comparator | Nutritional Intervention, fast Receives: Other: Nutritional Intervention |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startJul 2008
- Primary completionJul 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Minimal Hepatic EncephalopathyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Nachum Vaisman, Prof', Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083446
- Sponsor's protocol ID
- TASMC-08-NV-236
- Other IDs
- 0236-08-TLV
- Status last verified
- Jun 2008
- First submitted
- 17 Jun 2008
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Vaisman N, Katzman H, Carmiel-Haggai M, Lusthaus M, Niv E. Breakfast improves cognitive function in cirrhotic patients with cognitive impairment. Am J Clin Nutr. 2010 Jul;92(1):137-40. doi: 10.3945/ajcn.2010.29211. Epub 2010 May 5.
PubMed 20444959
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nutritional Approach to Minimal Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT01083446
- Acronym / sponsor ID
- TASMC-08-NV-236
- Conditions
- Minimal Hepatic Encephalopathy
- Keywords
- Encephalopathy, Cirrhotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2008
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 9 Mar 2010 (estimated)
- 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.
This trial will study a possible effect of standard Israeli breakfast (30% of caloric value and 21 gram protein) on cognitive and executive functions (working memory, visual memory, concentration and coordination), on patients with mild-moderate liver cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Other: Nutritional InterventionNutritional intervention, standard Israeli breakfast |
| B | Active comparator | Other: Nutritional InterventionNutritional Intervention, fast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All consented adults (age > 18), with the diagnosis of CHILD A cirrhosis with MELD score of < 10.
- Diagnosis of liver cirrhosis as documented by liver biopsy (stage IV) and / or fibroscan (score > 12 kpa) and / or fibrotest (score > 0.74) and /or imaging.
Key exclusion criteria (5 listed)
- History of > grade II hepatic encephalopathy (HE).
- Diagnosis of dementia, Parkinson disease, Schizophrenia (Patients with major depression will be noted but not excluded).
- Use of sedatives, tranquilizers or anti- psychotic medication during and/or 2 weeks prior to enrolling Use of antibiotics for any length of period during and/or 2 weeks prior to enrolling.
- Current use of lactulose or neomycin.
- Use of alcohol or elicit drugs during and/ or 6 months prior to enrolling.
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 |
|---|---|---|
| Nutritional InterventionCognitive and executive functions before and after standard israeli breakfast (30% of caloric value and 21 gram protein) | Other | A |
| Nutritional InterventionCognitive and executive functions during fast | Other | B |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2010.
- Derived from this study: PubMed 20444959Vaisman N, Katzman H, Carmiel-Haggai M, Lusthaus M, Niv E. Breakfast improves cognitive function in cirrhotic patients with cognitive impairment. Am J Clin Nutr. 2010 Jul;92(1):137-40. doi: 10.3945/ajcn.2010.29211. Epub 2010 May 5.
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Minimal Hepatic Encephalopathy
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. This study is not recruiting at the moment.
Nachum Vaisman, Prof' principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Intervention in people with Minimal Hepatic Encephalopathy, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Mar 2010. 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 Israel. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nachum Vaisman, Prof' (+972-3-6974807, vaisman@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01083446, which also lists 1 linked publication.
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 9 Mar 2010.