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

A.O. Ospedale Papa Giovanni XXIII50 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hepatic Encephalopathy

Interventions

Eligibility

Sex: ALLMin age: 4 YearsMax age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * extra-hepatic portal vein thrombosis * 4-20 years * knowledge of italian language * absence of perceptive or communicative deficit * absence of psychiatric disease or mental retardation Exclusion Criteria: * medical contraindications for required evaluations * infective pathologies * parenchymal hepatic pathologies

Outcomes

Primary Outcomes

neuropsychological and electrophysiological aspects

Improvement in the spectrum of the digitalised electroencephalogram, improvement in the performance of the psychometric tests