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

Cirrhosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004796
• Other study ID #: 199/11934
• Secondary ID: NU-523
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2000
• Last updated: June 23, 2005
• Start date: November 1994
• Est. completion date: February 1997

Study information

• Verified date: February 1998
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 1997
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 64 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Cirrhosis
• Hepatic Encephalopathy
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Drug:
• lactulose

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	Northwestern University