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

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 2

Conditions: Hepatic Encephalopathy; Portal Hypertension; Cirrhosis

Treatments: Drug: lactulose

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004796

NU-523

199/11934

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: Under 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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