Study of Lactulose in Children With Chronic Liver Disease (MHE)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Clinical diagnosis of MHE as result of cognitive, developmental testing, pediatric pt. with cirrhosis as evidenced by imaging/biopsy
Exclusion criteria
- 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
16 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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