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Evaluation of Probiotics in the Treatment of Portal Hypertension

Primary Purpose

Liver Cirrhosis, Portal Hypertension, Encephalopathy

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
VSL3
Sponsored by
Pomeranian Medical University Szczecin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Cirrhosis focused on measuring VSL3, Probiotics, Gut microbiota, Cytokines, Portal hypertension, Chemokines, Liver cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Gastroenterology, Pomeranian Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Liver cirrhosis compensated

Liver cirrhosis decompensated

Control group

Arm Description

VSL3 supplemented twice daily for 28 days

VSL3 supplemented twice daily for 28 days

VSL3 supplemented twice daily for 28 days

Outcomes

Primary Outcome Measures

Laboratory data

Secondary Outcome Measures

Clinical and laboratory data

Full Information

First Posted
January 27, 2009
Last Updated
November 21, 2016
Sponsor
Pomeranian Medical University Szczecin
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1. Study Identification

Unique Protocol Identification Number
NCT00831337
Brief Title
Evaluation of Probiotics in the Treatment of Portal Hypertension
Official Title
The Study of Probiotics in Liver Cirrhosis Patients With Portal Hypertension.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pomeranian Medical University Szczecin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Studied probiotics: VSL3

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Portal Hypertension, Encephalopathy
Keywords
VSL3, Probiotics, Gut microbiota, Cytokines, Portal hypertension, Chemokines, Liver cirrhosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liver cirrhosis compensated
Arm Type
Experimental
Arm Description
VSL3 supplemented twice daily for 28 days
Arm Title
Liver cirrhosis decompensated
Arm Type
Experimental
Arm Description
VSL3 supplemented twice daily for 28 days
Arm Title
Control group
Arm Type
Experimental
Arm Description
VSL3 supplemented twice daily for 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
VSL3
Intervention Description
2 times daily 450 billion live bacteria (in each saschet)
Primary Outcome Measure Information:
Title
Laboratory data
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Clinical and laboratory data
Time Frame
1 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wojciech M Marlicz, M.D., Ph.D.
Organizational Affiliation
Pomeranian Medical University Szczecin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, Pomeranian Medical University
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Probiotics in the Treatment of Portal Hypertension

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