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

A.O. Ospedale Papa Giovanni XXIII

Status and phase: Unknown; Phase 3

Conditions: Hepatic Encephalopathy

Treatments: Dietary Supplement: probiotic VSL#3

Study type: Interventional

Funder types: Other

Identifiers

NCT01798329

ETOS

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 4 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 2 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

Probiotic VSL#3 for 15 weeks, dosage variations according to the weight

Treatment:

Dietary Supplement: probiotic VSL#3

Placebo

Placebo Comparator group

Description:

subjects treated with placebo for 15 weeks