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A Nutritional Approach to Minimal Hepatic Encephalopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01083446
Recruitment Status : Unknown
Verified June 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : March 9, 2010
Last Update Posted : March 9, 2010
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment
Minimal Hepatic Encephalopathy Other: Nutritional Intervention

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Nutritional Approach to Minimal Hepatic Encephalopathy
Study Start Date : July 2008
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
Nutritional intervention, standard Israeli breakfast
Other: Nutritional Intervention
Cognitive and executive functions before and after standard israeli breakfast (30% of caloric value and 21 gram protein)
Active Comparator: B
Nutritional Intervention, fast
Other: Nutritional Intervention
Cognitive and executive functions during fast




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083446


Contacts
Contact: Nachum Vaisman, Prof' +972-3-6974807 vaisman@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Nachum Vaisman, Prof'    +972-3-6974807    vaisman@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Nachum Vaisman, Prof' Tel-Aviv Sourasky Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof' Nachum Vaisman, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01083446     History of Changes
Other Study ID Numbers: TASMC-08-NV-236
0236-08-TLV
First Posted: March 9, 2010    Key Record Dates
Last Update Posted: March 9, 2010
Last Verified: June 2008

Keywords provided by Tel-Aviv Sourasky Medical Center:
Encephalopathy
Cirrhotics

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases