Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis
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|ClinicalTrials.gov Identifier: NCT00004796|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Portal Hypertension Hepatic Encephalopathy Cirrhosis||Drug: lactulose||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||16 participants|
|Study Start Date :||November 1994|
|Study Completion Date :||February 1997|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004796
|Study Chair:||Andres Blei||Northwestern University|