A Nutritional Approach to Minimal Hepatic Encephalopathy

Minimal Hepatic Encephalopathy Clinical Trial

Official title:

A Nutritional Approach to Minimal Hepatic Encephalopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01083446
• Other study ID #: TASMC-08-NV-236
• Secondary ID: 0236-08-TLV
• Status: Recruiting
• Phase: N/A
• First received: June 17, 2008
• Last updated: March 8, 2010
• Start date: July 2008
• Est. completion date: August 2010

Study information

• Verified date: June 2008
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nachum Vaisman, Prof'
• Phone: +972-3-6974807
• Email: vaisman[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy
• Minimal Hepatic Encephalopathy

Intervention

Other:
• Nutritional Intervention
Cognitive and executive functions before and after standard israeli breakfast (30% of caloric value and 21 gram protein)
• Nutritional Intervention
Cognitive and executive functions during fast

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel,