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

This study has been completed.

First Received on February 24, 2000. Last Updated on June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	Northwestern University
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004796

Purpose

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.

Condition	Intervention	Phase
Portal Hypertension Hepatic Encephalopathy Cirrhosis	Drug: lactulose	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis High Blood Pressure

Drug Information available for: Lactulose

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	16
Study Start Date:	November 1994
Estimated Study Completion Date:	February 1997

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

Ages Eligible for Study:	up to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004796

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Northwestern University

Investigators

Study Chair:

Andres Blei

Northwestern University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004796 History of Changes
Other Study ID Numbers:	199/11934, NU-523
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

cardiovascular and respiratory diseases
cirrhosis
gastrointestinal disorders

hypertensive disorder
portal hypertension
rare disease

Additional relevant MeSH terms:

Hepatic Encephalopathy
Hypertension
Hypertension, Portal
Liver Cirrhosis
Fibrosis
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012