Study of Lactulose in Children With Chronic Liver Disease

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Minimal Hepatic Encephalopathy

In brief

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.

Key facts

Study ID

NCT00811434

Run by

Indiana University

People needed

16

Starts

2009-01-01

Expected to finish

2010-11-01

Last updated by the study team

2014-02-10

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• James Whitcomb Riley Hospital for Children — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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