Cirrhosis, Hepatic Encephalopathy, Portal Hypertension
Conditions
Keywords
cardiovascular and respiratory diseases, cirrhosis, gastrointestinal disorders, hypertensive disorder, portal hypertension, rare disease
Brief summary
OBJECTIVES: I. Assess the effect of lactulose on the circadian rhythm of plasma melatonin in patients with subclinical hepatic encephalopathy. II. Assess the intrasubject variability of circadian melatonin levels and neuropsychological tests. III. Assess which elements of the neuropsychological test battery show the response to lactulose.
Detailed description
PROTOCOL OUTLINE: Patients are alternately assigned to 1 of 2 treatment groups: no therapy for 3 weeks followed by lactulose for 3 weeks versus lactulose for 3 weeks followed by no therapy for 3 weeks. A dietician advises patients on a 1 g/kg per day protein diet. The lactulose dose is adjusted to result in 2 or 3 loose bowel movements per day.
Interventions
DRUGlactulose
Sponsors
Northwestern University
National Center for Research Resources (NCRR)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
0 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Clinical diagnosis of cirrhosis with portal hypertension or portal-systemic shunting --Prior/Concurrent Therapy-- * No concurrent therapy for hepatic encephalopathy --Patient Characteristics-- * Age: Under 65 * Performance status: Not specified * Hematopoietic: Not specified * Hepatic: See Disease Characteristics * Renal: Not specified * Other: No alcohol intake within 1 month prior to entry No requirement for beta blockers No requirement for corticosteroids Not in intercontinental travel
Outcome results
None listed