Portal HypertensionPhase 2NCT00004796
Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis
A Phase 2 study testing lactulose in people with Portal Hypertension and Hepatic Encephalopathy, run by National Center for Research Resources (NCRR).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 64 years
- Conditions the study is for
- Portal Hypertension, Hepatic Encephalopathy, Cirrhosis
- What is being tested?
- lactulose
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Nov 1994to Feb 1997
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
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
About this study
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.
Read the 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.
- Conditions
- Portal Hypertension, Hepatic Encephalopathy, Cirrhosis
- Being tested
- lactulose
- Keywords
- cardiovascular and respiratory diseases, cirrhosis, gastrointestinal disorders, hypertensive disorder, portal hypertension, rare disease
- Medical subject headings
- Hypertension, Portal, Hepatic Encephalopathy, Fibrosis, Respiratory Tract Diseases, Gastrointestinal Diseases, Hypertension, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactuloseDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startNov 1994
- Study completionFeb 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 16 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Northwestern University
- Investigators
- Andres Blei, Study chair, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004796
- Sponsor's protocol ID
- 199/11934
- Other IDs
- NU-523
- Status last verified
- Feb 1998
- First submitted
- 24 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis
- ClinicalTrials.gov ID
- NCT00004796
- Acronym / sponsor ID
- 199/11934
- Conditions
- Portal Hypertension, Hepatic Encephalopathy, Cirrhosis
- Keywords
- cardiovascular and respiratory diseases, cirrhosis, gastrointestinal disorders, hypertensive disorder, portal hypertension, rare disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Northwestern University
- Study start
- Nov 1994
- Study completion
- Feb 1997
- First posted
- 25 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 0 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lactulose | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres Blei study chair
Northwestern University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lactulose in people with Portal Hypertension and Hepatic Encephalopathy, run by National Center for Research Resources (NCRR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005; AzTrials last refreshed its copy on 7 Nov 2026.