Back to resultsA Nutritional Approach to Minimal Hepatic Encephalopathy
Primary Purpose
Minimal Hepatic Encephalopathy
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Nutritional Intervention
Nutritional Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Minimal Hepatic Encephalopathy focused on measuring Encephalopathy, Cirrhotics
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Tel Aviv Sourasky Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
Nutritional intervention, standard Israeli breakfast
Nutritional Intervention, fast
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01083446
First Posted
June 17, 2008
Last Updated
March 8, 2010
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01083446
Brief Title
A Nutritional Approach to Minimal Hepatic Encephalopathy
Official Title
A Nutritional Approach to Minimal Hepatic Encephalopathy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimal Hepatic Encephalopathy
Keywords
Encephalopathy, Cirrhotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Nutritional intervention, standard Israeli breakfast
Arm Title
B
Arm Type
Active Comparator
Arm Description
Nutritional Intervention, fast
Intervention Type
Other
Intervention Name(s)
Nutritional Intervention
Intervention Description
Cognitive and executive functions before and after standard israeli breakfast (30% of caloric value and 21 gram protein)
Intervention Type
Other
Intervention Name(s)
Nutritional Intervention
Intervention Description
Cognitive and executive functions during fast
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nachum Vaisman, Prof'
Phone
+972-3-6974807
Email
vaisman@tasmc.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nachum Vaisman, Prof'
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nachum Vaisman, Prof'
Phone
+972-3-6974807
Email
vaisman@tasmc.health.gov.il
12. IPD Sharing Statement
Citations:
PubMed Identifier
20444959
Citation
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.
Results Reference
derived
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A Nutritional Approach to Minimal Hepatic Encephalopathy
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