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

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ClinicalTrials.gov Identifier: NCT01798329
Recruitment Status : Unknown
Verified February 2013 by Dr. Lorenzo D'Antiga, A.O. Ospedale Papa Giovanni XXIII.
Recruitment status was:  Not yet recruiting
First Posted : February 25, 2013
Last Update Posted : February 25, 2013
Sponsor:
Collaborator:
University of Padua
Information provided by (Responsible Party):
Dr. Lorenzo D'Antiga, A.O. Ospedale Papa Giovanni XXIII

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.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Dietary Supplement: probiotic VSL#3 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Active Comparator: Probiotic
Probiotic VSL#3 for 15 weeks, dosage variations according to the weight
Dietary Supplement: probiotic VSL#3

VSL#3 is a probiotic that reduces:

  • urease faecal activity
  • faecal pH
  • inflammatory cytokine

Placebo Comparator: Placebo
subjects treated with placebo for 15 weeks



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. biochemical blood test [ Time Frame: after 15 weeks of probiotic or placebo treatment ]
    Decreased level of serum ammonia

  2. urine and faeces analysis [ Time Frame: after 15 weeks of probiotic or placebo treatment ]
  3. abdomen scan with color doppler technique [ Time Frame: after 15 weeks of probiotic or placebo treatment ]
  4. neurological evaluation [ Time Frame: after 15 weeks of probiotic or placebo treatment ]
  5. dietary anamnesis (last three days) [ Time Frame: after 15 weeks of probiotic or placebo treatment ]
  6. bowel frequency and characteristics [ Time Frame: after 15 weeks of probiotic or placebo treatment ]


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Ages Eligible for Study:   4 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798329


Contacts
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Contact: Lorenzo D'Antiga, MD +39 0352673856 ldantiga@hpg23.it
Contact: Ave Maria Biffi, psychologist +39 0352674482 abiffi@hpg23.it

Locations
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Italy
Azienda Ospedaliera Papa Giovanni XXIII Not yet recruiting
Bergamo, Italy, 24127
Contact: Lorenzo D'Antiga, MD    +39 0352673856    ldantiga@hpg23.it   
Principal Investigator: LORENZO D'ANTIGA, MD         
Sub-Investigator: MICHELA BRAVI, MD         
Sub-Investigator: VALERIA CASOTTI, MD         
Sub-Investigator: MARA COLUSSO, MD         
Sub-Investigator: MARCO PEZZANI, MD         
Sub-Investigator: LORELLA CAFFI, MD         
Sub-Investigator: EMILIO UBIALI, MD         
Sub-Investigator: MARIA SIMONETTA SPADA, PSYCHOLOGIST         
Sub-Investigator: AVE MARIA BIFFI, PSYCHOLOGIST         
Sub-Investigator: SILVIA BULLA, PSYCHOLOGIST         
Sub-Investigator: PAOLA PREVITALI, PSYCHOLOGIST         
Sub-Investigator: VERONICA FACCHINETTI, PSYCHOLOGIST         
Sub-Investigator: CRISTINA MORO, PSYCHOLOGIST         
University of Padua Active, not recruiting
Padova, Italy
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
University of Padua

Publications:
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Responsible Party: Dr. Lorenzo D'Antiga, MD, Director of Pediatric Unit, A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier: NCT01798329     History of Changes
Other Study ID Numbers: ETOS
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: February 25, 2013
Last Verified: February 2013

Keywords provided by Dr. Lorenzo D'Antiga, A.O. Ospedale Papa Giovanni XXIII:
Minimal Hepatic Encephalopathy
Pre-hepatic Portal Hypertension
portal vein thrombosis

Additional relevant MeSH terms:
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Hepatic Encephalopathy
Hypertension, Portal
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases