NCT00831337

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

3.6 years

First QC Date

January 27, 2009

Last Update Submit

November 21, 2016

Conditions

Liver CirrhosisPortal HypertensionEncephalopathy

Keywords

VSL3ProbioticsGut microbiotaCytokinesPortal hypertensionChemokinesLiver cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Laboratory data

    28 days

Secondary Outcomes (1)

  • Clinical and laboratory data

    1 months

Study Arms (3)

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

VSL3DIETARY_SUPPLEMENT

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

Control groupLiver cirrhosis compensatedLiver cirrhosis decompensated

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed liver cirrhosis (liver biopsy or typical imaging studies)
  • Confirmed portal hypertension
  • years and older
  • compliant patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Pomeranian Medical University

Szczecin, 71-252, Poland

Location

MeSH Terms

Conditions

Liver CirrhosisHypertension, PortalBrain Diseases

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Wojciech M Marlicz, M.D., Ph.D.

    Pomeranian Medical University Szczecin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 28, 2009

Study Start

April 1, 2007

Primary Completion

November 1, 2010

Study Completion

February 1, 2011

Last Updated

November 23, 2016

Record last verified: 2016-11

Locations

PL(1)