Clinical trial NCT01798329: ETOS: Minimal Hepatic Encephalopathy in Childhood and Young Adult: epidemiOlogical Study and Pilot Interventional Study
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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatic Encephalopathy
Keywords: Minimal Hepatic Encephalopathy
Pre-hepatic Portal Hypertension
portal vein thrombosis
Lead sponsor: A.O. Ospedale Papa Giovanni XXIII
Sponsor class: OTHER
Collaborators: name: University of Padova
First posted: 2013-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: neuropsychological and electrophysiological aspects
timeFrame: after 15 weeks of probiotic or placebo treatment
Secondary outcomes:
measure: biochemical blood test
timeFrame: after 15 weeks of probiotic or placebo treatment
measure: urine and faeces analysis
timeFrame: after 15 weeks of probiotic or placebo treatment
measure: abdomen scan with color doppler technique
timeFrame: after 15 weeks of probiotic or placebo treatment
measure: neurological evaluation
timeFrame: after 15 weeks of probiotic or placebo treatment
measure: dietary anamnesis (last three days)
timeFrame: after 15 weeks of probiotic or placebo treatment
measure: bowel frequency and characteristics
timeFrame: after 15 weeks of probiotic or placebo treatment
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Padova
country: Italy
facility: University of Padua
Study officials:
References:
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.
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.
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.
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.