Study of Lactulose in Children With Chronic Liver Disease

NCT ID: NCT00811434

Last Updated: 2014-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-11-30

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.

Conditions

Minimal Hepatic Encephalopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Lactulose

3 months of Lactulose therapy based on pt. weight

Group Type: ACTIVE_COMPARATOR

Lactulose

Intervention Type: DRUG

1.5cc/kg/day po for three months

placebo

1.5 ml/kg day po of sugar water placebo for three months

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

1.5 ml sugar water/kg day for three months

Interventions

Lactulose

1.5cc/kg/day po for three months

Intervention Type: DRUG

placebo

1.5 ml sugar water/kg day for three months

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Girish Subbarao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

James Whitcomb Riley Hospital for Children

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

Clarian Grant VFR-279

Identifier Type: -

Identifier Source: secondary_id

0808-19

Identifier Type: -

Identifier Source: org_study_id