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

This study has been completed.

Sponsor:

Collaborator:

Northwestern University

Information provided by:

Office of Rare Diseases (ORD)

ClinicalTrials.gov Identifier:

NCT00004796

First received: February 24, 2000

Last updated: June 23, 2005

Last verified: February 1998

History of Changes

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 2


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

Drug Information available for: Lactulose

Genetic and Rare Diseases Information Center resources: Hepatic Encephalopathy

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 (Child, Adult)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

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:


Hypertension Fibrosis Liver Cirrhosis Brain Diseases Hepatic Encephalopathy Hypertension, Portal Vascular Diseases Cardiovascular Diseases Pathologic Processes Liver Diseases	Digestive System Diseases Central Nervous System Diseases Nervous System Diseases Liver Failure Hepatic Insufficiency Brain Diseases, Metabolic Metabolic Diseases Lactulose Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 20, 2017

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