Study of Lactulose in Children With Chronic Liver Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Minimal Hepatic Encephalopathy

Intervention / Treatment
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* Drug: Lactulose
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactulose<br>3 months of Lactulose therapy based on pt. weight | Drug: Lactulose<br>* 1.5cc/kg/day po for three months<br>|
| Placebo Comparator: placebo<br>1.5 ml/kg day po of sugar water placebo for three months | Drug: placebo<br>* 1.5 ml sugar water/kg day for three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis | failure of one cognitive function test indicates presence of MHE | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life (HRQOL) | HRQOL administered to parents prior to treatment | baseline | 
| Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function | MHE as measured by failure of one or more cognitive test | before and after each treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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encephalopathy, pediatric liver disease, pediatric cirrhosis, serum ammonia levels