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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
16
James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, United States
Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis
failure of one cognitive function test indicates presence of MHE
Time frame: baseline
Health Related Quality of Life (HRQOL)
HRQOL administered to parents prior to treatment
Time frame: baseline
Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function
MHE as measured by failure of one or more cognitive test
Time frame: before and after each treatment period
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