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The Effect of Probiotics (VSL) on Portal Hypertension

NCT01032941 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2012-01-20

No results posted yet for this study

Summary

The investigators will address the hypothesis that portal hypertension is mediated in part by bacterial or endotoxin translocation and the production of inflammatory mediators (tumor necrosis factor-α (TNFα), etc.). The investigators hypothesize that food supplementation with the probiotic product VSL#3 in patients with Child Pugh B/C cirrhosis will have a beneficial effect on in portal pressure (as measured by the HVPG) by reducing inflammatory mediators and improving systemic and splanchnic hemodynamics.

Conditions

  • Portal Hypertension

Interventions

DRUG

Probiotic

Patients in this group will be given the probiotic VSL#3 2 packets BID for a total of 8 weeks.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Puneeta Tandon, MD, FRCPC, MSc · University of Alberta

  • Vince Bain, MD, FRCPC · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01032941 on ClinicalTrials.gov