NCT01798329

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

2 years

First QC Date

February 19, 2013

Last Update Submit

February 21, 2013

Conditions

Hepatic Encephalopathy

Keywords

Minimal Hepatic EncephalopathyPre-hepatic Portal Hypertensionportal vein thrombosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • biochemical blood test

    after 15 weeks of probiotic or placebo treatment

  • urine and faeces analysis

    after 15 weeks of probiotic or placebo treatment

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Probiotic VSL#3 for 15 weeks, dosage variations according to the weight

Dietary Supplement: probiotic VSL#3

Placebo

PLACEBO COMPARATOR

subjects treated with placebo for 15 weeks

Interventions

probiotic VSL#3DIETARY_SUPPLEMENT

VSL#3 is a probiotic that reduces: * urease faecal activity * faecal pH * inflammatory cytokine

Probiotic

Eligibility Criteria

Age4 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • extra-hepatic portal vein thrombosis
  • years
  • knowledge of italian language
  • absence of perceptive or communicative deficit
  • absence of psychiatric disease or mental retardation

You may not qualify if:

  • medical contraindications for required evaluations
  • infective pathologies
  • parenchymal hepatic pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

University of Padua

Padua, Italy

Location

Related Publications (4)

  • 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.

    PMID: 15554421BACKGROUND

  • 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.

    PMID: 18602716BACKGROUND

  • 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.

    PMID: 10454268BACKGROUND

  • 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.

    PMID: 10347105BACKGROUND

MeSH Terms

Conditions

Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Lorenzo D'Antiga, MD

CONTACT

+39 0352673856ldantiga@hpg23.it

Ave Maria Biffi, psychologist

CONTACT

+39 0352674482abiffi@hpg23.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Director of Pediatric Unit

Study Record Dates

First Submitted

February 19, 2013

First Posted

February 25, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2015

Study Completion

September 1, 2015

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

IT(2)