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

February 7, 2014 updated by: Indiana University

Improvement of Cognitive Function and Healthcare -Related Quality of Life After Lactulose Treatment in Children With Chronic Liver Disease

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis
Time Frame: baseline
failure of one cognitive function test indicates presence of MHE
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Related Quality of Life (HRQOL)
Time Frame: baseline
HRQOL administered to parents prior to treatment
baseline
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
before and after each treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Girish Subbarao, M.D., Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 18, 2008

First Posted (Estimate)

December 19, 2008

Study Record Updates

Last Update Posted (Estimate)

February 10, 2014

Last Update Submitted That Met QC Criteria

February 7, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0808-19
  • Clarian Grant VFR-279

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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