Evaluation of Probiotics in the Treatment of Portal Hypertension

November 21, 2016 updated by: Wojciech Marlicz, Pomeranian Medical University Szczecin

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Studied probiotics: VSL3

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Szczecin, Poland, 71-252
        • Department of Gastroenterology, Pomeranian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Laboratory data
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical and laboratory data
Time Frame: 1 months
1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pomeranian Medical University Szczecin

Investigators

  • Principal Investigator: Wojciech M Marlicz, M.D., Ph.D., Pomeranian Medical University Szczecin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (Estimate)

January 28, 2009

Study Record Updates

Last Update Posted (Estimate)

November 23, 2016

Last Update Submitted That Met QC Criteria

November 21, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAM 12/06/PB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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