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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00811434
Recruitment Status : Terminated (funding period ended)
First Posted : December 19, 2008
Results First Posted : February 10, 2014
Last Update Posted : February 10, 2014
Information provided by (Responsible Party):
Indiana University

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.

Condition or disease Intervention/treatment Phase
Minimal Hepatic Encephalopathy Drug: Lactulose Drug: placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : January 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
Drug Information available for: Lactulose

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis [ Time Frame: baseline ]
    failure of one cognitive function test indicates presence of MHE

Secondary Outcome Measures :
  1. Health Related Quality of Life (HRQOL) [ Time Frame: baseline ]
    HRQOL administered to parents prior to treatment

  2. Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function [ Time Frame: before and after each treatment period ]
    MHE as measured by failure of one or more cognitive test

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00811434

United States, Indiana
James Whitcomb Riley Hospital for Children
INdianapolis,, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Principal Investigator: Girish Subbarao, M.D. Indiana University

Responsible Party: Indiana University Identifier: NCT00811434     History of Changes
Other Study ID Numbers: 0808-19
Clarian Grant VFR-279
First Posted: December 19, 2008    Key Record Dates
Results First Posted: February 10, 2014
Last Update Posted: February 10, 2014
Last Verified: February 2014

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

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