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Evaluation of Probiotics in the Treatment of Portal Hypertension

NCT ID: NCT00831337

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-02-28

Brief Summary

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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

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Studied probiotics: VSL3

Conditions

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Liver Cirrhosis Portal Hypertension Encephalopathy

Keywords

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VSL3 Probiotics Gut microbiota Cytokines Portal hypertension Chemokines Liver cirrhosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Liver cirrhosis compensated

VSL3 supplemented twice daily for 28 days

Group Type EXPERIMENTAL

VSL3

Intervention Type DIETARY_SUPPLEMENT

2 times daily 450 billion live bacteria (in each saschet)

Liver cirrhosis decompensated

VSL3 supplemented twice daily for 28 days

Group Type EXPERIMENTAL

VSL3

Intervention Type DIETARY_SUPPLEMENT

2 times daily 450 billion live bacteria (in each saschet)

Control group

VSL3 supplemented twice daily for 28 days

Group Type EXPERIMENTAL

VSL3

Intervention Type DIETARY_SUPPLEMENT

2 times daily 450 billion live bacteria (in each saschet)

Interventions

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VSL3

2 times daily 450 billion live bacteria (in each saschet)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pomeranian Medical University Szczecin

OTHER

Sponsor Role lead

Responsible Party

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Wojciech Marlicz

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wojciech M Marlicz, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Pomeranian Medical University Szczecin

Locations

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Department of Gastroenterology, Pomeranian Medical University

Szczecin, , Poland

Site Status

Countries

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Poland

Other Identifiers

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PAM 12/06/PB

Identifier Type: -

Identifier Source: org_study_id