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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

January 27, 2009
July 19, 2011
April 2007
November 2010   (final data collection date for primary outcome measure)
Laboratory data [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Laboratory data [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00831337 on ClinicalTrials.gov Archive Site
Clinical and laboratory data [ Time Frame: 1 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Probiotics in the Treatment of Portal Hypertension
The Study of Probiotics in Liver Cirrhosis Patients With 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.

Studied probiotics: VSL3 and Lactobacillus plantarum 299v
Observational
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Patients with confirmed liver cirrhosis
  • Liver Cirrhosis
  • Portal Hypertension
  • Dietary Supplement: VSL3
    2 times daily 450 billion live bacteria (in each saschet)
  • Dietary Supplement: Lactobacillus plantarum 299v
    20 billion bacteria (2 capsules daily) given daily to patients as a food supplement
    Other Name: Sanprobi IBS
  • VSL3
    VSL3 supplemented twice daily for 14 days
    Intervention: Dietary Supplement: VSL3
  • 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
    Intervention: Dietary Supplement: Lactobacillus plantarum 299v
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2011
November 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00831337
PAM 12/06/PB
Yes
Wojciech Marlicz M.D., Ph.D., Pomeranian Medical University
Pomeranian Medical University Szczecin
Not Provided
Principal Investigator: Wojciech M Marlicz, M.D., Ph.D. Pomeranian Medical University Szczecin
Pomeranian Medical University Szczecin
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP