drugset / Trial / NCT00811434

Study of Lactulose in Children With Chronic Liver Disease

NCT00811434

Phase 2 Terminated 16 enrolled Indiana University
RandomizedCrossoverTriple-blindTreatment

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.

Timeline

Start
2009-01
Primary completion
2010-11
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lactulose Other / unclassified 1.5 ml Oral