Evaluation of Probiotics in the Treatment of Portal Hypertension

Pomeranian Medical University Szczecin33 enrolled

Overview

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.

Studied probiotics: VSL3

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Liver Cirrhosis Portal Hypertension Encephalopathy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Laboratory data

Time frame: 28 days

Secondary Outcomes

Clinical and laboratory data

Time frame: 1 months