NCT00004796

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 1994

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1994

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 1997

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

February 1, 1998

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

Portal HypertensionHepatic EncephalopathyCirrhosis

Keywords

cardiovascular and respiratory diseasescirrhosisgastrointestinal disordershypertensive disorderportal hypertensionrare disease

Interventions

lactuloseDRUG

Eligibility Criteria

Age0 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension, PortalHepatic EncephalopathyFibrosisRespiratory Tract DiseasesGastrointestinal DiseasesHypertensionRare Diseases

Interventions

Lactulose

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesLiver FailureHepatic InsufficiencyBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesDisease Attributes

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Andres Blei

    Northwestern University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

November 1, 1994

Study Completion

February 1, 1997

Last Updated

June 24, 2005

Record last verified: 1998-02