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NCT Number: NCT00831337

Evaluation of Probiotics in the Treatment of 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.

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Key information

Conditions

Liver Cirrhosis Brain Diseases Central Nervous System Diseases Digestive System Diseases Encephalopathy Fibrosis Hypertension, Portal Liver Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, Pomeranian Medical University

Szczecin, 71-252, Poland

About this study

Studied probiotics: VSL3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VSL3

Dietary Supplement

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

Primary outcomes

  1. Laboratory data

    Time frame: 28 days

Secondary outcomes

  1. Clinical and laboratory data

    Time frame: 1 months

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Jan 28, 2009
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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