NCT00004796

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 0 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Portal Hypertension
• Hepatic Encephalopathy
• Cirrhosis

Interventions

Type	Name	Description
DRUG	lactulose

Timeline

• Start date: 1994-11-01
• Completion: 1997-02-01
• First posted: 2000-02-25
• Last updated: 2005-06-24