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

February 21, 2013 updated by: Dr. Lorenzo D'Antiga, A.O. Ospedale Papa Giovanni XXIII

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

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.

Study Overview

Status

Unknown

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ave Maria Biffi, psychologist
  • Phone Number: +39 0352674482
  • Email: abiffi@hpg23.it

Study Locations

      • Bergamo, Italy, 24127
        • Azienda Ospedaliera Papa Giovanni XXIII
        • Contact:
        • Principal Investigator:
          • LORENZO D'ANTIGA, MD
        • Sub-Investigator:
          • MICHELA BRAVI, MD
        • Sub-Investigator:
          • VALERIA CASOTTI, MD
        • Sub-Investigator:
          • MARA COLUSSO, MD
        • Sub-Investigator:
          • MARCO PEZZANI, MD
        • Sub-Investigator:
          • LORELLA CAFFI, MD
        • Sub-Investigator:
          • EMILIO UBIALI, MD
        • Sub-Investigator:
          • MARIA SIMONETTA SPADA, PSYCHOLOGIST
        • Sub-Investigator:
          • AVE MARIA BIFFI, PSYCHOLOGIST
        • Sub-Investigator:
          • SILVIA BULLA, PSYCHOLOGIST
        • Sub-Investigator:
          • PAOLA PREVITALI, PSYCHOLOGIST
        • Sub-Investigator:
          • VERONICA FACCHINETTI, PSYCHOLOGIST
        • Sub-Investigator:
          • CRISTINA MORO, PSYCHOLOGIST
      • Padova, Italy
        • University of Padua

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Probiotic
Probiotic VSL#3 for 15 weeks, dosage variations according to the weight

VSL#3 is a probiotic that reduces:

  • urease faecal activity
  • faecal pH
  • inflammatory cytokine
Placebo Comparator: Placebo
subjects treated with placebo for 15 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neuropsychological and electrophysiological aspects
Time Frame: after 15 weeks of probiotic or placebo treatment
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
Time Frame: after 15 weeks of probiotic or placebo treatment
Decreased level of serum ammonia
after 15 weeks of probiotic or placebo treatment
urine and faeces analysis
Time Frame: after 15 weeks of probiotic or placebo treatment
after 15 weeks of probiotic or placebo treatment
abdomen scan with color doppler technique
Time Frame: after 15 weeks of probiotic or placebo treatment
after 15 weeks of probiotic or placebo treatment
neurological evaluation
Time Frame: after 15 weeks of probiotic or placebo treatment
after 15 weeks of probiotic or placebo treatment
dietary anamnesis (last three days)
Time Frame: after 15 weeks of probiotic or placebo treatment
after 15 weeks of probiotic or placebo treatment
bowel frequency and characteristics
Time Frame: after 15 weeks of probiotic or placebo treatment
after 15 weeks of probiotic or placebo treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 25, 2013

Study Record Updates

Last Update Posted (Estimate)

February 25, 2013

Last Update Submitted That Met QC Criteria

February 21, 2013

Last Verified

February 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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