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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hepatic Encephalopathy

Intervention / Treatment
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* Dietary Supplement: probiotic VSL#3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br>Probiotic VSL#3 for 15 weeks, dosage variations according to the weight | Dietary Supplement: probiotic VSL#3<br>* VSL#3 is a probiotic that reduces: urease faecal activity faecal pH inflammatory cytokine<br>|
| Placebo Comparator: Placebo<br>subjects treated with placebo for 15 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuropsychological and electrophysiological aspects | Improvement in the spectrum of the digitalised electroencephalogram, improvement in the performance of the psychometric tests | after 15 weeks of probiotic or placebo treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemical blood test | Decreased level of serum ammonia | after 15 weeks of probiotic or placebo treatment | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimal Hepatic Encephalopathy, Pre-hepatic Portal Hypertension, portal vein thrombosis