- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004796
Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis
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.
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Andres Blei, Northwestern University
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Liver Failure
- Hepatic Insufficiency
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Liver Diseases
- Brain Diseases, Metabolic
- Fibrosis
- Hypertension
- Liver Cirrhosis
- Hepatic Encephalopathy
- Brain Diseases
- Hypertension, Portal
- Gastrointestinal Agents
- Lactulose
Other Study ID Numbers
- 199/11934
- NU-523
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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