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

Phase 3

• Conditions: Hepatic Encephalopathy
• Interventions: Dietary Supplement: probiotic VSL#3

• Registration Number: NCT01798329
• Lead Sponsor: A.O. Ospedale Papa Giovanni XXIII

Brief 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

Study Timeline

• Status Verified: 2013-02
• Study First Submitted: 2013-02-19
• Study First Submitted QC: 2013-02-21
• Last Update Submitted: 2013-02-21
• Study First Posted: 2013-02-25
• Last Update Posted: 2013-02-25
• Study Start: 2013-03
• Primary Completion: 2015-03
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	probiotic VSL#3	Probiotic VSL#3 for 15 weeks, dosage variations according to the weight

Primary Outcome Measures

Name	Time	Method
neuropsychological and electrophysiological aspects	after 15 weeks of probiotic or placebo treatment	Improvement in the spectrum of the digitalised electroencephalogram, improvement in the performance of the psychometric tests

Secondary Outcome Measures

Name	Time	Method
biochemical blood test	after 15 weeks of probiotic or placebo treatment	Decreased level of serum ammonia
urine and faeces analysis	after 15 weeks of probiotic or placebo treatment
abdomen scan with color doppler technique	after 15 weeks of probiotic or placebo treatment
neurological evaluation	after 15 weeks of probiotic or placebo treatment
dietary anamnesis (last three days)	after 15 weeks of probiotic or placebo treatment
bowel frequency and characteristics	after 15 weeks of probiotic or placebo treatment

Trial Locations

Locations (2)

Azienda Ospedaliera Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy

University of Padua; 🇮🇹 Padova, Italy