Liver CirrhosisNCT00831337
Evaluation of Probiotics in the Treatment of Portal Hypertension
A study testing VSL3 in people with Liver Cirrhosis and Portal Hypertension, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
This study is to evaluate the role of probiotics in the treatment of portal hypertension. In particular the role of probiotics on gut microbiota in liver cirrhosis patients will be studied and compared with cytokines and other substances implicated in the pathogenesis of portal hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis, Portal Hypertension, Encephalopathy
- What is being tested?
- VSL3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2007to Feb 2011
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed liver cirrhosis (liver biopsy or typical imaging studies)
- Confirmed portal hypertension
- 18 years and older
- compliant patients
Who cannot join
- Antibiotic treatment in last 3 months
- Lactulose treatment in last 3 months
- Patients taking NSAIDS in lat 3 months
- Steroid treatment in last 3 months
- Ongoing and active infection
- Pregnant woman
Show all 12Show fewer
- Cancer diagnosis
- decompensated diabetes mellitus
- active or past treatment with recombinant cytokines (e.g. anty TNF, interferon etc)
- medication altering function of CNS, suffering from neurological or ophthalmological conditions
- initiating the therapy with beta blockers within the prior 12 weeks
- mental disease
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Gastroenterology, Pomeranian Medical University
Szczecin, 71-252
About this study
Official title: The Study of Probiotics in Liver Cirrhosis Patients With Portal Hypertension.
This study is to evaluate the role of probiotics in the treatment of portal hypertension. In particular the role of probiotics on gut microbiota in liver cirrhosis patients will be studied and compared with cytokines and other substances implicated in the pathogenesis of portal hypertension. The hypothesis whether probiotics may change the prognosis of patients with portal hypertension will be studied. The hypothesis whether probiotics may halt the pathologic cascade of events leading to various complications (e.g. hepato-renal syndrome, spontaneous bacterial peritonitis, bleeding varices) will be reviewed.
Read the detailed description
Studied probiotics: VSL3
- Conditions
- Liver Cirrhosis, Portal Hypertension, Encephalopathy
- Being tested
- VSL3
- Keywords
- VSL3, Probiotics, Gut microbiota, Cytokines, Portal hypertension, Chemokines, Liver cirrhosis
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSL3Dietary supplement
2 times daily 450 billion live bacteria (in each saschet)
| Study group | Role | What they receive |
|---|---|---|
| Liver cirrhosis compensated | Experimental | VSL3 supplemented twice daily for 28 days Receives: Dietary Supplement: VSL3 |
| Liver cirrhosis decompensated | Experimental | VSL3 supplemented twice daily for 28 days Receives: Dietary Supplement: VSL3 |
| Control group | Experimental | VSL3 supplemented twice daily for 28 days Receives: Dietary Supplement: VSL3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory data
Measured: 28 days
Secondary outcomes (1)
Clinical and laboratory data
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startApr 2007
- Primary completionNov 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wojciech Marlicz, Pomeranian Medical University Szczecin
- Investigators
- Wojciech M Marlicz, M.D., Ph.D., Principal investigator, Pomeranian Medical University Szczecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831337
- Sponsor's protocol ID
- PAM 12/06/PB
- Status last verified
- Nov 2016
- First submitted
- 27 Jan 2009
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Probiotics in Liver Cirrhosis Patients With Portal Hypertension.
- ClinicalTrials.gov ID
- NCT00831337
- Acronym / sponsor ID
- PAM 12/06/PB
- Conditions
- Liver Cirrhosis, Portal Hypertension, Encephalopathy
- Keywords
- VSL3, Probiotics, Gut microbiota, Cytokines, Portal hypertension, Chemokines, Liver cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 28 Jan 2009 (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.
This study is to evaluate the role of probiotics in the treatment of portal hypertension. In particular the role of probiotics on gut microbiota in liver cirrhosis patients will be studied and compared with cytokines and other substances implicated in the pathogenesis of portal hypertension. The hypothesis whether probiotics may change the prognosis of patients with portal hypertension will be studied. The hypothesis whether probiotics may halt the pathologic cascade of events leading to various complications (e.g. hepato-renal syndrome, spontaneous bacterial peritonitis, bleeding varices) will be reviewed.
Detailed description
Studied probiotics: VSL3
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liver cirrhosis compensated | Experimental | Dietary Supplement: VSL3VSL3 supplemented twice daily for 28 days |
| Liver cirrhosis decompensated | Experimental | Dietary Supplement: VSL3VSL3 supplemented twice daily for 28 days |
| Control group | Experimental | Dietary Supplement: VSL3VSL3 supplemented twice daily for 28 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed liver cirrhosis (liver biopsy or typical imaging studies)
- Confirmed portal hypertension
- 18 years and older
- compliant patients
Key exclusion criteria (12 listed)
- Antibiotic treatment in last 3 months
- Lactulose treatment in last 3 months
- Patients taking NSAIDS in lat 3 months
- Steroid treatment in last 3 months
- Ongoing and active infection
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 |
|---|---|---|
| VSL32 times daily 450 billion live bacteria (in each saschet) | Dietary supplement | Control group, Liver cirrhosis compensated, Liver cirrhosis decompensated |
Primary outcome
Laboratory data
Time frame: 28 days
1 secondary outcome
Clinical and laboratory data
Time frame: 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
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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.
Wojciech M Marlicz, M.D., Ph.D. principal investigator
Pomeranian Medical University Szczecin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VSL3 in people with Liver Cirrhosis and Portal Hypertension, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory data (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2016; AzTrials last refreshed its copy on 8 Nov 2026.