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Impact of Probiotic Regimen on Vancomycin Resistant Enterococcus Intestinal Carriage

Phase 4
Conditions
Vancomycin Resistant Enterococcus Intestinal Carriage
Registration Number
NCT00437580
Lead Sponsor
University Hospital, Clermont-Ferrand
Brief Summary

This study aims to reduce the duration of VRE intestinal carriage by the administration of Lactobacillus casei rhamnosus (strain Lcr 35 LC). Patients will be blindly randomized to be assigned to a 5 weeks regimen with the probiotic (10 9 lactobacillus bid) or to a 5 weeks regimen with placebo.A stool culture will be performed every week for 5 weeks (during the administration of treatment) then every two weeks until 3 consecutive negative stool culture for VRE.

Detailed Description

This study aims to reduce the duration of VRE intestinal carriage by the administration of Lactobacillus casei rhamnosus (strain Lcr 35 LC). Patients will be blindly randomized to be assigned to a 5 weeks regimen with the probiotic (10 9 lactobacillus bid) or to a 5 weeks regimen with placebo.A stool culture will be performed every week for 5 weeks (during the administration of treatment) then every two weeks until 3 consecutive negative stool culture for VRE.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
24
Inclusion Criteria
  • Age >18;
  • Vancomycin Resistant Enterococcus intestinal carriage
Exclusion Criteria
  • Neutropenia <1000 /mm3,
  • Immunosuppressive drugs,
  • Inhalation

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Reduction of the duration of Vancomycin Resistant Enterococcus intestinal carriage.
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Service des Maladies infectieuses et tropicales

🇫🇷

Hôpital Gabriel Montpied, Clermont-Ferrand, France

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