Study of Lactulose in Children With Chronic Liver Disease (MHE)

This study has been terminated.
(funding period ended)
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00811434
First received: December 18, 2008
Last updated: February 7, 2014
Last verified: February 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
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:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis [ Time Frame: baseline ] [ Designated as safety issue: No ]
    failure of one cognitive function test indicates presence of MHE


Secondary Outcome Measures:
  • Health Related Quality of Life (HRQOL) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    HRQOL administered to parents prior to treatment

  • Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function [ Time Frame: before and after each treatment period ] [ Designated as safety issue: No ]
    MHE as measured by failure of one or more cognitive test


Enrollment: 16
Study Start Date: January 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lactulose
3 months of Lactulose therapy based on pt. weight
Drug: Lactulose
1.5cc/kg/day po for three months
Placebo Comparator: placebo
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Indiana University
ClinicalTrials.gov Identifier: NCT00811434     History of Changes
Other Study ID Numbers: 0808-19, Clarian Grant VFR-279
Study First Received: December 18, 2008
Results First Received: October 9, 2012
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
encephalopathy
pediatric liver disease
pediatric cirrhosis
serum ammonia levels

Additional relevant MeSH terms:
Liver Diseases
Hepatic Encephalopathy
Digestive System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014