Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis
Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis
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.
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.
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