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

Hepatic Encephalopathy Clinical Trial

— ETOS  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01798329
• Other study ID #: ETOS
• Status: Not yet recruiting
• Phase: Phase 3
• First received: February 19, 2013
• Last updated: February 21, 2013
• Start date: March 2013
• Est. completion date: September 2015

Study information

• Verified date: February 2013
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: Lorenzo D'Antiga, MD
• Phone: +39 0352673856
• Email: ldantiga[@]hpg23.it
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 20 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy
• Hypertension, Portal

Intervention

Dietary Supplement:
• probiotic VSL#3
VSL#3 is a probiotic that reduces: urease faecal activity faecal pH inflammatory cytokine

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo
Italy	University of Padua	Padova

Sponsors (2)

Lead Sponsor	Collaborator
A.O. Ospedale Papa Giovanni XXIII	University of Padua

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	biochemical blood test	Decreased level of serum ammonia	after 15 weeks of probiotic or placebo treatment	No
Secondary	urine and faeces analysis		after 15 weeks of probiotic or placebo treatment	No
Secondary	abdomen scan with color doppler technique		after 15 weeks of probiotic or placebo treatment	No
Secondary	neurological evaluation		after 15 weeks of probiotic or placebo treatment	No
Secondary	dietary anamnesis (last three days)		after 15 weeks of probiotic or placebo treatment	No
Secondary	bowel frequency and characteristics		after 15 weeks of probiotic or placebo treatment	No