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| Name | Class |
|---|---|
| University of Padova | OTHER |
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The aim of the study is:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator | Probiotic VSL#3 for 15 weeks, dosage variations according to the weight |
|
| Placebo | Placebo Comparator | subjects treated with placebo for 15 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotic VSL#3 | Dietary Supplement | VSL#3 is a probiotic that reduces:
|
|
| Measure | Description | Time Frame |
|---|---|---|
| neuropsychological and electrophysiological aspects | Improvement in the spectrum of the digitalised electroencephalogram, improvement in the performance of the psychometric tests | after 15 weeks of probiotic or placebo treatment |
| Measure | Description | Time Frame |
|---|---|---|
| biochemical blood test | Decreased level of serum ammonia | after 15 weeks of probiotic or placebo treatment |
| urine and faeces analysis | after 15 weeks of probiotic or placebo treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo D'Antiga, MD | Contact | +39 0352673856 | ldantiga@hpg23.it | |
| Ave Maria Biffi, psychologist | Contact | +39 0352674482 | abiffi@hpg23.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15554421 | Background | 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. | |
| 18602716 | Background | 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. |
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| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| abdomen scan with color doppler technique | after 15 weeks of probiotic or placebo treatment |
| neurological evaluation | after 15 weeks of probiotic or placebo treatment |
| dietary anamnesis (last three days) | after 15 weeks of probiotic or placebo treatment |
| bowel frequency and characteristics | after 15 weeks of probiotic or placebo treatment |
| University of Padua | Padova | Italy |
| 10454268 | Background | 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. |
| 10347105 | Background | 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. |
| D001928 |
| Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |