Study of Lactulose in Children With Chronic Liver Disease

Phase 2

Terminated

• Conditions: Minimal Hepatic Encephalopathy
• Interventions: Drug: placebo; Drug: Lactulose

• Registration Number: NCT00811434
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2008-12-18
• Study First Submitted QC: 2008-12-18
• Study First Posted: 2008-12-19
• Study Start: 2009-01
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2012-10-09
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-07
• Last Update Submitted: 2014-02-07
• Results First Posted: 2014-02-10
• Last Update Posted: 2014-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	placebo	1.5 ml/kg day po of sugar water placebo for three months
Lactulose	Lactulose	3 months of Lactulose therapy based on pt. weight

Primary Outcome Measures

Name	Time	Method
Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis	baseline	failure of one cognitive function test indicates presence of MHE

Secondary Outcome Measures

Name	Time	Method
Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function	before and after each treatment period	MHE as measured by failure of one or more cognitive test
Health Related Quality of Life (HRQOL)	baseline	HRQOL administered to parents prior to treatment

Trial Locations

Locations (1)

James Whitcomb Riley Hospital for Children; 🇺🇸 INdianapolis,, Indiana, United States