Study of Lactulose in Children With Chronic Liver Disease - Full Text View

Sponsored by:	Indiana University
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00811434

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases

Drug Information available for: Lactulose

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:

Scores of cognitive/developmental testing will be altered following use of Lactulose therapy. [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lactulose treatment will show a change in serum ammonia levels. [ Time Frame: three months ] [ Designated as safety issue: No ]

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
Lactulose: Active Comparator 3 months of Lactulose therapy based on pt. weight	Drug: Lactulose 1.5cc/kg/day po for three months
placebo: Placebo Comparator 1.5 ml/kg day po of sugar water placebo for three months	Drug: placebo 1.5 ml sugar water/kg day for three months

Detailed 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.

Eligibility

Ages Eligible for Study:	5 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811434

Locations

United States, Indiana
James Whitcomb Riley Hospital for Children
INdianapolis,, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University

Investigators

Principal Investigator:

Girish Subbarao, M.D.

Indiana University

More Information

No publications provided

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

Keywords provided by Indiana University:

encephalopathy
pediatric liver disease
pediatric cirrhosis
serum ammonia levels

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 03, 2009