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

Primary Purpose

Hepatic Encephalopathy

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
probiotic VSL#3
Sponsored by
A.O. Ospedale Papa Giovanni XXIII
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring Minimal Hepatic Encephalopathy, Pre-hepatic Portal Hypertension, portal vein thrombosis

Eligibility Criteria

4 Years - 20 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Azienda Ospedaliera Papa Giovanni XXIII
  • University of Padua

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

Probiotic VSL#3 for 15 weeks, dosage variations according to the weight

subjects treated with placebo for 15 weeks

Outcomes

Primary Outcome Measures

neuropsychological and electrophysiological aspects
Improvement in the spectrum of the digitalised electroencephalogram, improvement in the performance of the psychometric tests

Secondary Outcome Measures

biochemical blood test
Decreased level of serum ammonia
urine and faeces analysis
abdomen scan with color doppler technique
neurological evaluation
dietary anamnesis (last three days)
bowel frequency and characteristics

Full Information

First Posted
February 19, 2013
Last Updated
February 21, 2013
Sponsor
A.O. Ospedale Papa Giovanni XXIII
Collaborators
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT01798329
Brief Title
ETOS: Minimal Hepatic Encephalopathy in Childhood and Young Adult: epidemiOlogical Study and Pilot Interventional Study
Acronym
ETOS
Official Title
Minimal Hepatic Encephalopathy in Pre-hepatic Portal Hypertension Due to Portal Vein Thrombosis in Childhood and Young Adult: epidemiOlogical Study and Pilot Interventional Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
A.O. Ospedale Papa Giovanni XXIII
Collaborators
University of Padova

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
Keywords
Minimal Hepatic Encephalopathy, Pre-hepatic Portal Hypertension, portal vein thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
Probiotic VSL#3 for 15 weeks, dosage variations according to the weight
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
subjects treated with placebo for 15 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotic VSL#3
Intervention Description
VSL#3 is a probiotic that reduces: urease faecal activity faecal pH inflammatory cytokine
Primary Outcome Measure Information:
Title
neuropsychological and electrophysiological aspects
Description
Improvement in the spectrum of the digitalised electroencephalogram, improvement in the performance of the psychometric tests
Time Frame
after 15 weeks of probiotic or placebo treatment
Secondary Outcome Measure Information:
Title
biochemical blood test
Description
Decreased level of serum ammonia
Time Frame
after 15 weeks of probiotic or placebo treatment
Title
urine and faeces analysis
Time Frame
after 15 weeks of probiotic or placebo treatment
Title
abdomen scan with color doppler technique
Time Frame
after 15 weeks of probiotic or placebo treatment
Title
neurological evaluation
Time Frame
after 15 weeks of probiotic or placebo treatment
Title
dietary anamnesis (last three days)
Time Frame
after 15 weeks of probiotic or placebo treatment
Title
bowel frequency and characteristics
Time Frame
after 15 weeks of probiotic or placebo treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorenzo D'Antiga, MD
Phone
+39 0352673856
Email
ldantiga@hpg23.it
First Name & Middle Initial & Last Name or Official Title & Degree
Ave Maria Biffi, psychologist
Phone
+39 0352674482
Email
abiffi@hpg23.it
Facility Information:
Facility Name
Azienda Ospedaliera Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo D'Antiga, MD
Phone
+39 0352673856
Email
ldantiga@hpg23.it
First Name & Middle Initial & Last Name & Degree
LORENZO D'ANTIGA, MD
First Name & Middle Initial & Last Name & Degree
MICHELA BRAVI, MD
First Name & Middle Initial & Last Name & Degree
VALERIA CASOTTI, MD
First Name & Middle Initial & Last Name & Degree
MARA COLUSSO, MD
First Name & Middle Initial & Last Name & Degree
MARCO PEZZANI, MD
First Name & Middle Initial & Last Name & Degree
LORELLA CAFFI, MD
First Name & Middle Initial & Last Name & Degree
EMILIO UBIALI, MD
First Name & Middle Initial & Last Name & Degree
MARIA SIMONETTA SPADA, PSYCHOLOGIST
First Name & Middle Initial & Last Name & Degree
AVE MARIA BIFFI, PSYCHOLOGIST
First Name & Middle Initial & Last Name & Degree
SILVIA BULLA, PSYCHOLOGIST
First Name & Middle Initial & Last Name & Degree
PAOLA PREVITALI, PSYCHOLOGIST
First Name & Middle Initial & Last Name & Degree
VERONICA FACCHINETTI, PSYCHOLOGIST
First Name & Middle Initial & Last Name & Degree
CRISTINA MORO, PSYCHOLOGIST
Facility Name
University of Padua
City
Padova
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
15554421
Citation
Amodio P, Montagnese S, Gatta A, Morgan MY. Characteristics of minimal hepatic encephalopathy. Metab Brain Dis. 2004 Dec;19(3-4):253-67. doi: 10.1023/b:mebr.0000043975.01841.de.
Results Reference
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PubMed Identifier
18602716
Citation
Amodio P, Campagna F, Olianas S, Iannizzi P, Mapelli D, Penzo M, Angeli P, Gatta A. Detection of minimal hepatic encephalopathy: normalization and optimization of the Psychometric Hepatic Encephalopathy Score. A neuropsychological and quantified EEG study. J Hepatol. 2008 Sep;49(3):346-53. doi: 10.1016/j.jhep.2008.04.022. Epub 2008 Jun 2.
Results Reference
background
PubMed Identifier
10454268
Citation
Amodio P, Marchetti P, Del Piccolo F, de Tourtchaninoff M, Varghese P, Zuliani C, Campo G, Gatta A, Guerit JM. Spectral versus visual EEG analysis in mild hepatic encephalopathy. Clin Neurophysiol. 1999 Aug;110(8):1334-44. doi: 10.1016/s1388-2457(99)00076-0.
Results Reference
background
PubMed Identifier
10347105
Citation
Amodio P, Del Piccolo F, Marchetti P, Angeli P, Iemmolo R, Caregaro L, Merkel C, Gerunda G, Gatta A. Clinical features and survivial of cirrhotic patients with subclinical cognitive alterations detected by the number connection test and computerized psychometric tests. Hepatology. 1999 Jun;29(6):1662-7. doi: 10.1002/hep.510290619.
Results Reference
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ETOS: Minimal Hepatic Encephalopathy in Childhood and Young Adult: epidemiOlogical Study and Pilot Interventional Study

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