Trial | NCT00831337  Report issue

Title

Evaluation of Probiotics in the Treatment of Portal Hypertension
The Study of Probiotics in Liver Cirrhosis Patients With Portal Hypertension.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    33
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 Started
Apr 30
2007
Primary Completion
Nov 30
2010
Study Completion
Feb 28
2011
Last Update
Nov 23
2016
Estimate

Dietary Supplement VSL3

2 times daily 450 billion live bacteria (in each saschet)

Liver cirrhosis compensated Experimental

VSL3 supplemented twice daily for 28 days

  • Dietary Supplement VSL3

Liver cirrhosis decompensated Experimental

VSL3 supplemented twice daily for 28 days

  • Dietary Supplement VSL3

Control group Experimental

VSL3 supplemented twice daily for 28 days

  • Dietary Supplement VSL3

Criteria 

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
No Results Posted