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Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis Clinical research trials and Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis. Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis clinical trial. Subjects frequently get the best healthcare possible for their Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.

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



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

For Condition: Hepatic Encephalopathy,Portal Hypertension,Cirrhosis
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Northwestern University
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /64 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 16

Location and Contact Information:

Overall Study Official:
AndresBlei,  Study Chair,  Northwestern University


Additional Information:
Study ID Numbers:
  199/11934;  NU-523
Study Start Date: November 1994
Record last reviewed: February 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004796

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