Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis
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ClinicalTrials.gov Identifier: NCT00004796 |
Recruitment Status :
Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Portal Hypertension Hepatic Encephalopathy Cirrhosis | Drug: lactulose | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 16 participants |
Primary Purpose: | Treatment |
Study Start Date : | November 1994 |
Study Completion Date : | February 1997 |


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Ages Eligible for Study: | 0 Years to 64 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004796
Study Chair: | Andres Blei | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00004796 |
Other Study ID Numbers: |
199/11934 NU-523 |
First Posted: | February 25, 2000 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | February 1998 |
cardiovascular and respiratory diseases cirrhosis gastrointestinal disorders |
hypertensive disorder portal hypertension rare disease |
Liver Cirrhosis Hypertension, Portal Hepatic Encephalopathy Brain Diseases Hypertension Fibrosis Vascular Diseases Cardiovascular Diseases Pathologic Processes Liver Diseases |
Digestive System Diseases Central Nervous System Diseases Nervous System Diseases Liver Failure Hepatic Insufficiency Brain Diseases, Metabolic Metabolic Diseases Lactulose Gastrointestinal Agents |