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Evaluation of Probiotics in the Treatment of Portal Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wojciech Marlicz, Pomeranian Medical University Szczecin
ClinicalTrials.gov Identifier:
NCT00831337
First received: January 27, 2009
Last updated: November 21, 2016
Last verified: November 2016
  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
Encephalopathy
Dietary Supplement: VSL3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Study of Probiotics in Liver Cirrhosis Patients With Portal Hypertension.

Resource links provided by NLM:


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: 33
Study Start Date: April 2007
Study Completion Date: February 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liver cirrhosis compensated
VSL3 supplemented twice daily for 28 days
Dietary Supplement: VSL3
2 times daily 450 billion live bacteria (in each saschet)
Experimental: Liver cirrhosis decompensated
VSL3 supplemented twice daily for 28 days
Dietary Supplement: VSL3
2 times daily 450 billion live bacteria (in each saschet)
Experimental: Control group
VSL3 supplemented twice daily for 28 days
Dietary Supplement: VSL3
2 times daily 450 billion live bacteria (in each saschet)

Detailed Description:
Studied probiotics: VSL3
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Wojciech Marlicz, MD PhD, Pomeranian Medical University Szczecin
ClinicalTrials.gov Identifier: NCT00831337     History of Changes
Other Study ID Numbers: PAM 12/06/PB 
Study First Received: January 27, 2009
Last Updated: November 21, 2016
Health Authority: Poland: Ministry of Health

Keywords provided by Pomeranian Medical University Szczecin:
VSL3
Probiotics
Gut microbiota
Cytokines
Portal hypertension
Chemokines
Liver cirrhosis

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

ClinicalTrials.gov processed this record on December 07, 2016