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Study of Lactulose in Children With Chronic Liver Disease — MHE  

Minimal Hepatic Encephalopathy Clinical Trial

Official title:
Improvement of Cognitive Function and Healthcare -Related Quality of Life After Lactulose Treatment in Children With Chronic Liver Disease

Clinical Trial 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 developmental testing we will determine if patients have MHE. If so, we will trial 3 months of blinded placebo or Lactulose treatment followed by a washout period with no treatment. At this time patients are re-tested and then begin another three month period switching to the opposite treatment of first 3 months.Final cognitive/developmental testing will determine if Lactulose treatment has any effect on MHE.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00811434
Study type Interventional
Source Indiana University
Contact
Status Terminated
Phase Phase 2
Start date January 2009
Completion date November 2010
View Details
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