Hepatic EncephalopathyPhase 3ETOSNCT01798329
ETOS: Minimal Hepatic Encephalopathy in Childhood and Young Adult: epidemiOlogical Study and Pilot Interventional Study
A Phase 3 study testing probiotic VSL#3 in people with Hepatic Encephalopathy, run by A.O. Ospedale Papa Giovanni XXIII at 2 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 4 to 20 years
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- probiotic VSL#3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- Mar 2013to Sep 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- medical contraindications for required evaluations
- infective pathologies
- parenchymal hepatic pathologies
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127
Lorenzo D'Antiga, MD, +39 0352673856, ldantiga@hpg23.it
LORENZO D'ANTIGA, MD
University of Padua
Padova
About this study
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.
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.
Read the 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
- Conditions
- Hepatic Encephalopathy
- Being tested
- probiotic VSL#3
- Keywords
- Minimal Hepatic Encephalopathy, Pre-hepatic Portal Hypertension, portal vein thrombosis
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic VSL#3Dietary supplement
VSL#3 is a probiotic that reduces:
- urease faecal activity
- faecal pH
- inflammatory cytokine
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Probiotic VSL#3 for 15 weeks, dosage variations according to the weight Receives: Dietary Supplement: probiotic VSL#3 |
| Placebo | Placebo comparator | subjects treated with placebo for 15 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuropsychological and electrophysiological aspects
Improvement in the spectrum of the digitalised electroencephalogram, improvement in the performance of the psychometric tests
Measured: after 15 weeks of probiotic or placebo treatment
Secondary outcomes (6)
biochemical blood test
Decreased level of serum ammonia
Measured: after 15 weeks of probiotic or placebo treatment
urine and faeces analysis
Measured: after 15 weeks of probiotic or placebo treatment
abdomen scan with color doppler technique
Measured: after 15 weeks of probiotic or placebo treatment
neurological evaluation
Measured: after 15 weeks of probiotic or placebo treatment
dietary anamnesis (last three days)
Measured: after 15 weeks of probiotic or placebo treatment
bowel frequency and characteristics
Measured: after 15 weeks of probiotic or placebo treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIII
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova
- Responsible party
- Principal investigator, Dr. Lorenzo D'Antiga, A.O. Ospedale Papa Giovanni XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798329
- Sponsor's protocol ID
- ETOS
- Acronym
- ETOS
- Status last verified
- Feb 2013
- First submitted
- 19 Feb 2013
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15554421Amodio 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.
PubMed 18602716Amodio 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.
PubMed 10454268Amodio 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.
PubMed 10347105
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01798329
- Acronym / sponsor ID
- ETOS / ETOS
- Conditions
- Hepatic Encephalopathy
- Keywords
- Minimal Hepatic Encephalopathy, Pre-hepatic Portal Hypertension, portal vein thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIIIUniversity, hospital or other
- Collaborators
- University of Padova
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 25 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: probiotic VSL#3Probiotic VSL#3 for 15 weeks, dosage variations according to the weight |
| Placebo | Placebo comparator | –subjects treated with placebo for 15 weeks |
Who may qualify
- Ages
- 4 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- medical contraindications for required evaluations
- infective pathologies
- parenchymal hepatic pathologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotic VSL#3VSL#3 is a probiotic that reduces: * urease faecal activity * faecal pH * inflammatory cytokine | Dietary supplement | Probiotic |
Primary outcome
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
6 secondary outcomes
biochemical blood test
Time frame: after 15 weeks of probiotic or placebo treatment
urine and faeces analysis
Time frame: after 15 weeks of probiotic or placebo treatment
abdomen scan with color doppler technique
Time frame: after 15 weeks of probiotic or placebo treatment
neurological evaluation
Time frame: after 15 weeks of probiotic or placebo treatment
dietary anamnesis (last three days)
Time frame: after 15 weeks of probiotic or placebo treatment
bowel frequency and characteristics
Time frame: after 15 weeks of probiotic or placebo treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
- Background: PubMed 15554421Amodio 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.
- Background: PubMed 18602716Amodio 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.
- Background: PubMed 10454268Amodio 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.
- Background: PubMed 10347105Amodio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing probiotic VSL#3 in people with Hepatic Encephalopathy, run by A.O. Ospedale Papa Giovanni XXIII at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo D'Antiga, MD (+39 0352673856, ldantiga@hpg23.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuropsychological and electrophysiological aspects (time frame: after 15 weeks of probiotic or placebo treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01798329, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2013.