MedTrace Logo

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

NCT01798329 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-02-25

No results posted yet for this study

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.

Conditions

  • Hepatic Encephalopathy

Interventions

DIETARY_SUPPLEMENT

probiotic VSL#3

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

Sponsors & Collaborators

  • University of Padova

    collaborator OTHER

  • A.O. Ospedale Papa Giovanni XXIII

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-03-31
Completion
2015-09-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01798329 on ClinicalTrials.gov