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.
|Portal Hypertension Hepatic Encephalopathy Cirrhosis||Drug: lactulose||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||November 1994|
|Estimated Study Completion Date:||February 1997|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004796
|Study Chair:||Andres Blei||Northwestern University|