Study of Lactulose in Children With Chronic Liver Disease

NCT00811434 | Terminated Phase 2 Results DMC

• 2 other identifiers: 0808-19Clarian Grant VFR-279
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Minimal Hepatic Encephalopathy

Keywords

encephalopathy; pediatric liver disease; pediatric cirrhosis; serum ammonia levels

Outcome Measures

Primary Outcomes (1)

• Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis

  failure of one cognitive function test indicates presence of MHE

  baseline

Secondary Outcomes (2)

• Health Related Quality of Life (HRQOL)

  baseline

• Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function

  before and after each treatment period

Study Arms (2)

Lactulose

ACTIVE COMPARATOR

3 months of Lactulose therapy based on pt. weight

Drug: Lactulose

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Lactulose DRUG

1.5cc/kg/day po for three months

Lactulose

placebo DRUG

1.5 ml sugar water/kg day for three months

placebo

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical diagnosis of MHE as result of cognitive, developmental testing, pediatric pt. with cirrhosis as evidenced by imaging/biopsy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

James Whitcomb Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Brain Diseases

Interventions

Lactulose

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Results Point of Contact

• Title: Girish Subbarao
• Organization: Riley Hospital

gsrao@iupui.edu

317-944-3774

Study Officials

• Girish Subbarao, M.D.

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: January 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 10, 2014
• Results First Posted: February 10, 2014

Record last verified: 2014-02

Locations

US (1)