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

Primary Purpose

Portal Hypertension, Hepatic Encephalopathy, Cirrhosis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

lactulose

About this trial

This is an interventional treatment trial for Portal Hypertension focused on measuring cardiovascular and respiratory diseases, cirrhosis, gastrointestinal disorders, hypertensive disorder, portal hypertension, rare disease

Eligibility Criteria

0 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004796

First Posted

February 24, 2000

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT00004796

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 1998

Overall Recruitment Status

Completed

Study Start Date

November 1994 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 1997 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

Northwestern University

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Portal Hypertension, Hepatic Encephalopathy, Cirrhosis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

16 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

lactulose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andres Blei

Organizational Affiliation

Northwestern University

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

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

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