Back to resultsStudy of Lactulose in Children With Chronic Liver Disease (MHE)
Primary Purpose
Minimal Hepatic Encephalopathy
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lactulose
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Minimal Hepatic Encephalopathy focused on measuring encephalopathy, pediatric liver disease, pediatric cirrhosis, serum ammonia levels
Eligibility 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.
Sites / Locations
- James Whitcomb Riley Hospital for Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lactulose
placebo
Arm Description
3 months of Lactulose therapy based on pt. weight
1.5 ml/kg day po of sugar water placebo for three months
Outcomes
Primary Outcome Measures
Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis
failure of one cognitive function test indicates presence of MHE
Secondary Outcome Measures
Health Related Quality of Life (HRQOL)
HRQOL administered to parents prior to treatment
Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function
MHE as measured by failure of one or more cognitive test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00811434
Brief Title
Study of Lactulose in Children With Chronic Liver Disease
Acronym
MHE
Official Title
Improvement of Cognitive Function and Healthcare -Related Quality of Life After Lactulose Treatment in Children With Chronic Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
funding period ended
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimal Hepatic Encephalopathy
Keywords
encephalopathy, pediatric liver disease, pediatric cirrhosis, serum ammonia levels
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactulose
Arm Type
Active Comparator
Arm Description
3 months of Lactulose therapy based on pt. weight
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
1.5 ml/kg day po of sugar water placebo for three months
Intervention Type
Drug
Intervention Name(s)
Lactulose
Intervention Description
1.5cc/kg/day po for three months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1.5 ml sugar water/kg day for three months
Primary Outcome Measure Information:
Title
Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis
Description
failure of one cognitive function test indicates presence of MHE
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Health Related Quality of Life (HRQOL)
Description
HRQOL administered to parents prior to treatment
Time Frame
baseline
Title
Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function
Description
MHE as measured by failure of one or more cognitive test
Time Frame
before and after each treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Girish Subbarao, M.D.
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
James Whitcomb Riley Hospital for Children
City
INdianapolis,
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Lactulose in Children With Chronic Liver Disease
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