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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01798329

Acronym

ETOS

Enrollment

Registered

2013-02-25

Start date

2013-03-31

Completion date

2015-09-30

Last updated

2013-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy

Keywords

Minimal Hepatic Encephalopathy, Pre-hepatic Portal Hypertension, portal vein thrombosis

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

Interventions

DIETARY_SUPPLEMENTprobiotic VSL#3

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

4 Years to 20 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—
biochemical blood test	after 15 weeks of probiotic or placebo treatment	Decreased level of serum ammonia
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	—
neurological evaluation	after 15 weeks of probiotic or placebo treatment	—

Countries

Italy

Contacts

Primary ContactLorenzo D'Antiga, MD

ldantiga@hpg23.it+39 0352673856

Backup ContactAve Maria Biffi, psychologist

abiffi@hpg23.it+39 0352674482

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026