Evaluation of Probiotics in the Treatment of Portal Hypertension

The Study of Probiotics in Liver Cirrhosis Patients With Portal Hypertension.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00831337

Enrollment

Registered

2009-01-28

Start date

2007-04-30

Completion date

2011-02-28

Last updated

2016-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Encephalopathy, Liver Cirrhosis, Portal Hypertension

Keywords

VSL3, Probiotics, Gut microbiota, Cytokines, Portal hypertension, Chemokines, Liver cirrhosis

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

Interventions

DIETARY_SUPPLEMENTVSL3

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Laboratory data	28 days

Secondary

Measure	Time frame
Clinical and laboratory data	1 months

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026