- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01798329
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
Conditions
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
- Name: Lorenzo D'Antiga, MD
- Phone Number: +39 0352673856
- Email: ldantiga@hpg23.it
Study Contact Backup
- Name: Ave Maria Biffi, psychologist
- Phone Number: +39 0352674482
- Email: abiffi@hpg23.it
Study Locations
-
-
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Bergamo, Italy, 24127
- Azienda Ospedaliera Papa Giovanni XXIII
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Contact:
- Lorenzo D'Antiga, MD
- Phone Number: +39 0352673856
- Email: ldantiga@hpg23.it
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Principal Investigator:
- LORENZO D'ANTIGA, MD
-
Sub-Investigator:
- MICHELA BRAVI, MD
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Sub-Investigator:
- VALERIA CASOTTI, MD
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Sub-Investigator:
- MARA COLUSSO, MD
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Sub-Investigator:
- MARCO PEZZANI, MD
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Sub-Investigator:
- LORELLA CAFFI, MD
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Sub-Investigator:
- EMILIO UBIALI, MD
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Sub-Investigator:
- MARIA SIMONETTA SPADA, PSYCHOLOGIST
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Sub-Investigator:
- AVE MARIA BIFFI, PSYCHOLOGIST
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Sub-Investigator:
- SILVIA BULLA, PSYCHOLOGIST
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Sub-Investigator:
- PAOLA PREVITALI, PSYCHOLOGIST
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Sub-Investigator:
- VERONICA FACCHINETTI, PSYCHOLOGIST
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Sub-Investigator:
- CRISTINA MORO, PSYCHOLOGIST
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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:
|
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.
Collaborators
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.
General Publications
- 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.
- 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.
- 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.
- 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.
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETOS
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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