Evaluation of Probiotics in the Treatment of Portal Hyper... | NCT00831337

Studies
Evaluation of Probiotics in the Treatment of Portal Hypertension

NCT00831337

Sponsor

Pomeranian Medical University Szczecin

Status

Completed

Last Update Posted

Nov 23, 2016Estimated

Enrollment

33Actual

Phase

Not Applicable

Conditions

Liver Cirrhosis
Portal Hypertension
Encephalopathy

Interventions

VSL3

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Nov 2010Actual

Completion Date

Feb 2011Actual

First Submitted Date

Jan 27, 2009

First Submission Date that Met QC Criteria

Jan 27, 2009

First Posted Date

Jan 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2016

Last Update Posted Date

Nov 23, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wojciech Marlicz, MD PhD, Pomeranian Medical University SzczecinPrincipal Investigator

Lead Sponsor

Pomeranian Medical University SzczecinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liver cirrhosis compensated	Experimental	VSL3 supplemented twice daily for 28 days	Dietary Supplement: VSL3
Liver cirrhosis decompensated	Experimental	VSL3 supplemented twice daily for 28 days	Dietary Supplement: VSL3
Control group	Experimental	VSL3 supplemented twice daily for 28 days	Dietary Supplement: VSL3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VSL3	Dietary Supplement	2 times daily 450 billion live bacteria (in each saschet)	Control group Liver cirrhosis compensated Liver cirrhosis decompensated

Measure	Description	Time Frame
Laboratory data		28 days

Measure	Description	Time Frame
Clinical and laboratory data		1 months

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wojciech M Marlicz, M.D., Ph.D.	Pomeranian Medical University Szczecin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroenterology, Pomeranian Medical University		Szczecin		71-252	Poland

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis
D006975	Hypertension, Portal
D001927	Brain Diseases

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided