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

• ClinicalTrials.gov Identifier: NCT01798329
• Recruitment Status: Unknown
• First Posted: February 25, 2013
• Last Update Posted: February 25, 2013
• Sponsor: A.O. Ospedale Papa Giovanni XXIII
• Collaborator: University of Padova
• Information provided by (Responsible Party): Dr. Lorenzo D'Antiga, A.O. Ospedale Papa Giovanni XXIII

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Lorenzo D'Antiga, MD; +39 0352673856; ldantiga@hpg23.it

Contact: Ave Maria Biffi, psychologist; +39 0352674482; abiffi@hpg23.it

Locations

Italy

Azienda Ospedaliera Papa Giovanni XXIII

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

Padova, Italy

Sponsors and Collaborators

A.O. Ospedale Papa Giovanni XXIII

University of Padova

More Information

Publications:

Amodio P, Montagnese S, Gatta A, Morgan MY. Characteristics of minimal hepatic encephalopathy. Metab Brain Dis. 2004 Dec;19(3-4):253-67. Review.

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, Guérit JM. Spectral versus visual EEG analysis in mild hepatic encephalopathy. Clin Neurophysiol. 1999 Aug;110(8):1334-44.

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.

• Responsible Party: Dr. Lorenzo D'Antiga, MD, Director of Pediatric Unit, A.O. Ospedale Papa Giovanni XXIII
• ClinicalTrials.gov Identifier: NCT01798329
• Other Study ID Numbers: ETOS
• First Posted: February 25, 2013
• 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:

Hepatic Encephalopathy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Metabolic Diseases