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

This study has been completed.
Northwestern University
Information provided by:
Office of Rare Diseases (ORD) Identifier:
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: February 1998

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
Drug: lactulose
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

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.


Ages Eligible for Study:   up to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


--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
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Please refer to this study by its identifier: NCT00004796

Sponsors and Collaborators
Northwestern University
Study Chair: Andres Blei Northwestern University
  More Information

No publications provided Identifier: NCT00004796     History of Changes
Other Study ID Numbers: 199/11934, NU-523
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
cardiovascular and respiratory diseases
gastrointestinal disorders
hypertensive disorder
portal hypertension
rare disease

Additional relevant MeSH terms:
Hepatic Encephalopathy
Hypertension, Portal
Liver Cirrhosis
Brain Diseases
Brain Diseases, Metabolic
Cardiovascular Diseases
Central Nervous System Diseases
Digestive System Diseases
Hepatic Insufficiency
Liver Diseases
Liver Failure
Metabolic Diseases
Nervous System Diseases
Vascular Diseases
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses processed this record on October 20, 2014