Cirrhosis Clinical Trial
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.
;
Primary Purpose: Treatment
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