A Nutritional Approach to Minimal Hepatic Encephalopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01083446
First received: June 17, 2008
Last updated: March 8, 2010
Last verified: June 2008
  Purpose

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 Intervention
Minimal Hepatic Encephalopathy
Other: Nutritional Intervention
Other: Nutritional Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Nutritional Approach to Minimal Hepatic Encephalopathy

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment: 60
Study Start Date: July 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 17, 2008
Last Updated: March 8, 2010
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 01, 2014