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Evaluation of Probiotics in the Treatment of Portal Hypertension

This study has been completed.
Sponsor:
Information provided by:
Pomeranian Medical University Szczecin
ClinicalTrials.gov Identifier:
NCT00831337
First received: January 27, 2009
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Liver Cirrhosis
Portal Hypertension
 Dietary Supplement: VSL3
Dietary Supplement: Lactobacillus plantarum 299v

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: The Study of Probiotics in Liver Cirrhosis Patients With Portal Hypertension.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pomeranian Medical University Szczecin:

Primary Outcome Measures:
  • Laboratory data [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical and laboratory data [ Time Frame: 1 months ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: April 2007
Study Completion Date: February 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
VSL3
VSL3 supplemented twice daily for 14 days
 Dietary Supplement: VSL3
2 times daily 450 billion live bacteria (in each saschet)
Control group
No intervention in control healthy subjects. No intervention in liver cirrhosis control groups.
Lactobacillus plantarum 299v
Lactobacillus plantarum given twice daily as a food supplement
 Dietary Supplement: Lactobacillus plantarum 299v
20 billion bacteria (2 capsules daily) given daily to patients as a food supplement
Other Name: Sanprobi IBS

Detailed Description:

Studied probiotics: VSL3 and Lactobacillus plantarum 299v

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with confirmed liver cirrhosis

Criteria

Inclusion Criteria:

  • Confirmed liver cirrhosis
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831337

Locations
Poland
Department of Gastroenterology, Pomeranian Medical University
Szczecin, Poland, 71-252
Sponsors and Collaborators
Pomeranian Medical University Szczecin
Investigators
Principal Investigator: Wojciech M Marlicz, M.D., Ph.D. Pomeranian Medical University Szczecin
  More Information

No publications provided

Responsible Party: Wojciech Marlicz M.D., Ph.D., Pomeranian Medical University
ClinicalTrials.gov Identifier: NCT00831337     History of Changes
Other Study ID Numbers: PAM 12/06/PB
Study First Received: January 27, 2009
Last Updated: July 19, 2011
Health Authority: Poland: Ministry of Health

Keywords provided by Pomeranian Medical University Szczecin:
VSL3
Lactobacillus plantarum 299v
Probiotics
 Gut microbiota
Cytokines
Portal hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Portal
Liver Cirrhosis
Fibrosis
Vascular Diseases
 Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013