Evaluation of Probiotics in the Treatment of Portal Hypertension

Not Applicable

Completed

• Conditions: Portal Hypertension; Liver Cirrhosis; Encephalopathy
• Interventions: Dietary Supplement: VSL3

• Registration Number: NCT00831337
• Lead Sponsor: Pomeranian Medical University Szczecin

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

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-28
• Primary Completion: 2010-11
• Study Completion: 2011-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liver cirrhosis compensated	VSL3	VSL3 supplemented twice daily for 28 days
Liver cirrhosis decompensated	VSL3	VSL3 supplemented twice daily for 28 days
Control group	VSL3	VSL3 supplemented twice daily for 28 days

Primary Outcome Measures

Name	Time	Method
Laboratory data	28 days

Secondary Outcome Measures

Name	Time	Method
Clinical and laboratory data	1 months

Trial Locations

Locations (1)

Department of Gastroenterology, Pomeranian Medical University; 🇵🇱 Szczecin, Poland