NCT01798329

ETOS: Minimal Hepatic Encephalopathy in Childhood and Young Adult: epidemiOlogical Study and Pilot Interventional Study

Minimal Hepatic Encephalopathy in Pre-hepatic Portal Hypertension Due to Portal Vein Thrombosis in Childhood and Young Adult: epidemiOlogical Study and Pilot Interventional Study.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: A.O. Ospedale Papa Giovanni XXIII · Academic / Other
• Sex: All
• Age: 4 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is: * Epidemiological/observational: investigating the presence of neuropsychological and electrophysiological alterations, suggesting a condition of minimal hepatic encephalopathy(and its behavioral correlates), in childhood and young adulthood affected by pre-hepatic portal hypertension due to portal vein thrombosis, even for implementing specific diagnostic protocols. * Interventional: collecting preliminary data on the effects of a probiotic, in order to implement a controlled clinical study.

Detailed description

Epidemiological/observational study investigating the presence of neuropsychological and electrophysiological alterations, suggesting a condition of minimal hepatic encephalopathy(and its behavioral correlates), in childhood and young adulthood affected by pre-hepatic portal hypertension due to portal vein thrombosis, even for implementing specific diagnostic protocols

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	probiotic VSL#3	VSL#3 is a probiotic that reduces: * urease faecal activity * faecal pH * inflammatory cytokine

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-03-01
• Completion: 2015-09-01
• First posted: 2013-02-25
• Last updated: 2013-02-25

Locations

2 sites across 1 country: Italy