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

• Status: Completed
• Trial end date: 1997-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborator: Northwestern University
• Treatments: Lactulose

Criteria

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