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Sponsored by: |
Indiana University |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00811434 |
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.
Condition | Intervention | Phase |
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Minimal Hepatic Encephalopathy |
Drug: Lactulose Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Improvement of Cognitive Function and Healthcare -Related Quality of Life After Lactulose Treatment in Children With Chronic Liver Disease |
Estimated Enrollment: | 50 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Lactulose: Active Comparator
3 months of Lactulose therapy based on pt. weight
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Drug: Lactulose
1.5cc/kg/day po for three months
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placebo: Placebo Comparator
1.5 ml/kg day po of sugar water placebo for three months
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Drug: placebo
1.5 ml sugar water/kg day for three months
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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.
Ages Eligible for Study: | 5 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Indiana | |
James Whitcomb Riley Hospital for Children | |
INdianapolis,, Indiana, United States, 46202 |
Principal Investigator: | Girish Subbarao, M.D. | Indiana University |
Responsible Party: | Riley Hospital Dept. of Pediatric Gastroenterology,Hepatology and Nutrition ( Girish Subbarao, M.D. ) |
Study ID Numbers: | 0808-19, Clarian Grant VFR-279 |
Study First Received: | December 18, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00811434 History of Changes |
Health Authority: | United States: Institutional Review Board |
encephalopathy pediatric liver disease pediatric cirrhosis serum ammonia levels |
Liver Failure Liver Diseases Metabolic Diseases Central Nervous System Diseases Quality of Life Liver Cirrhosis Brain Diseases |
Hepatic Encephalopathy Digestive System Diseases Metabolic Disorder Hepatic Insufficiency Brain Diseases, Metabolic Lactulose |
Liver Failure Liver Diseases Metabolic Diseases Nervous System Diseases Gastrointestinal Agents Central Nervous System Diseases Brain Diseases |
Pharmacologic Actions Hepatic Encephalopathy Digestive System Diseases Therapeutic Uses Hepatic Insufficiency Brain Diseases, Metabolic Lactulose |