NCT00811434

Study of Lactulose in Children With Chronic Liver Disease

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Minimal Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	Lactulose	1.5cc/kg/day po for three months
DRUG	placebo	1.5 ml sugar water/kg day for three months

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2008-12-19
• Last updated: 2014-02-10
• Results posted: 2014-02-10

Locations

1 site across 1 country: United States