NCT00831337CompletedNot Applicable
The Study of Probiotics in Liver Cirrhosis Patients With Portal Hypertension.
Pomeranian Medical University Szczecin2 sites in 1 country33 target enrollmentStarted: April 1, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- Laboratory data
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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(1 months)
Investigators
Wojciech Marlicz
MD PhD
Pomeranian Medical University Szczecin
Study Sites (2)
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