Evaluation of Probiotics in the Treatment of Portal Hypertension

Study Overview
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Brief Summary
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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
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Studied probiotics: VSL3

Official Title
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The Study of Probiotics in Liver Cirrhosis Patients With Portal Hypertension.

Conditions
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Liver Cirrhosis, Portal Hypertension, Encephalopathy

Intervention / Treatment
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* Dietary Supplement: VSL3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed liver cirrhosis (liver biopsy or typical imaging studies) Confirmed portal hypertension 18 years and older compliant patients Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liver cirrhosis compensated<br>VSL3 supplemented twice daily for 28 days | Dietary Supplement: VSL3<br>* 2 times daily 450 billion live bacteria (in each saschet)<br>|
| Experimental: Liver cirrhosis decompensated<br>VSL3 supplemented twice daily for 28 days | Dietary Supplement: VSL3<br>* 2 times daily 450 billion live bacteria (in each saschet)<br>|
| Experimental: Control group<br>VSL3 supplemented twice daily for 28 days | Dietary Supplement: VSL3<br>* 2 times daily 450 billion live bacteria (in each saschet)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory data |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and laboratory data |  | 1 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VSL3, Probiotics, Gut microbiota, Cytokines, Portal hypertension, Chemokines, Liver cirrhosis