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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-11-30

Study Completion Date

1997-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cirrhosis Hepatic Encephalopathy Portal Hypertension

Keywords

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cardiovascular and respiratory diseases cirrhosis gastrointestinal disorders hypertensive disorder portal hypertension rare disease

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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lactulose

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

0 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Andres Blei

Role: STUDY_CHAIR

Northwestern University

Other Identifiers

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NU-523

Identifier Type: -

Identifier Source: secondary_id

199/11934