ETOS: Minimal Hepatic Encephalopathy in Childhood and Young Adult: epidemiOlogical Study and Pilot Interventional Study
NCT ID: NCT01798329
Last Updated: 2013-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2013-03-31
2015-09-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Probiotic
Probiotic VSL#3 for 15 weeks, dosage variations according to the weight
probiotic VSL#3
VSL#3 is a probiotic that reduces:
* urease faecal activity
* faecal pH
* inflammatory cytokine
Placebo
subjects treated with placebo for 15 weeks
No interventions assigned to this group
Interventions
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probiotic VSL#3
VSL#3 is a probiotic that reduces:
* urease faecal activity
* faecal pH
* inflammatory cytokine
Eligibility Criteria
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Inclusion Criteria
* 4-20 years
* knowledge of italian language
* absence of perceptive or communicative deficit
* absence of psychiatric disease or mental retardation
Exclusion Criteria
* infective pathologies
* parenchymal hepatic pathologies
4 Years
20 Years
ALL
No
Sponsors
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University of Padova
OTHER
A.O. Ospedale Papa Giovanni XXIII
OTHER
Responsible Party
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Dr. Lorenzo D'Antiga
MD, Director of Pediatric Unit
Locations
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Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
University of Padua
Padua, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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ETOS
Identifier Type: -
Identifier Source: org_study_id
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