Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Portal Hypertension; Hepatic Encephalopathy; Cirrhosis
Intervention: lactulose (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
Andres Blei, Study Chair, Affiliation: Northwestern University
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.
Clinical Details
Study design: Treatment
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.
Eligibility
Minimum age: N/A.
Maximum age: 64 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: November 1994
Ending date: February 1997
Last updated: June 23, 2005
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