Status:
TERMINATED
Study of Lactulose in Children With Chronic Liver Disease
Lead Sponsor:
Indiana University
Conditions:
Minimal Hepatic Encephalopathy
Eligibility:
All Genders
5-18 years
Phase:
PHASE2
Brief Summary
Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developm...
Detailed Description
In addition ,serum ammonia levels will be obtained at beginning of study,post-washout and at end of study to evaluate Lactulose effect on serum ammonia.
Eligibility Criteria
Inclusion
- Clinical diagnosis of MHE as result of cognitive, developmental testing, pediatric pt. with cirrhosis as evidenced by imaging/biopsy
Exclusion
- patients with neurological,psychiatric or unstable medical conditions which may contribute to impaired cognitive function.
- patients with known hearing or vision difficulties.
- those patients who do not speak English will be excluded.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00811434
Start Date
January 1 2009
End Date
November 1 2010
Last Update
February 10 2014
Active Locations (1)
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1
James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, United States, 46202