Study of Lactulose in Children With Chronic Liver Disease

Minimal Hepatic Encephalopathy Clinical Trial

— MHE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00811434
• Other study ID #: 0808-19
• Secondary ID: Clarian Grant VF
• Status: Terminated
• Phase: Phase 2
• First received: December 18, 2008
• Last updated: February 7, 2014
• Start date: January 2009
• Est. completion date: November 2010

Study information

• Verified date: February 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy
• Liver Diseases
• Minimal Hepatic Encephalopathy

Intervention

Drug:
• Lactulose
1.5cc/kg/day po for three months
• placebo
1.5 ml sugar water/kg day for three months

Locations

Country	Name	City	State
United States	James Whitcomb Riley Hospital for Children	INdianapolis,	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis	failure of one cognitive function test indicates presence of MHE	baseline	No
Secondary	Health Related Quality of Life (HRQOL)	HRQOL administered to parents prior to treatment	baseline	No
Secondary	Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function	MHE as measured by failure of one or more cognitive test	before and after each treatment period	No