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

June 17, 2008
March 8, 2010
July 2008
July 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01083446 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Nutritional Approach to Minimal Hepatic Encephalopathy
A Nutritional Approach to Minimal Hepatic Encephalopathy

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Minimal Hepatic Encephalopathy
  • Other: Nutritional Intervention
    Cognitive and executive functions before and after standard israeli breakfast (30% of caloric value and 21 gram protein)
  • Other: Nutritional Intervention
    Cognitive and executive functions during fast
  • Active Comparator: A
    Nutritional intervention, standard Israeli breakfast
    Intervention: Other: Nutritional Intervention
  • Active Comparator: B
    Nutritional Intervention, fast
    Intervention: Other: Nutritional Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
August 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Nachum Vaisman, Prof' +972-3-6974807 vaisman@tasmc.health.gov.il
Israel
 
NCT01083446
TASMC-08-NV-236, 0236-08-TLV
No
Prof' Nachum Vaisman, Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Principal Investigator: Nachum Vaisman, Prof' Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP