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Impact of Probiotic Regimen on Vancomycin Resistant Enterococcus Intestinal Carriage

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ClinicalTrials.gov Identifier: NCT00437580
Recruitment Status : Unknown
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : February 21, 2007
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Vancomycin Resistant Enterococcus Intestinal Carriage Drug: Lactobacillus casei rhamnosus (strain Lcr 35 LC) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Official Title: Impact of Probiotic Regimen on Vancomycin Resistant Enterococcus (VRE) Intestinal Carriage : a Double Blind Randomized Pilot Study
Study Start Date : February 2007
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Lactobacillus casei rhamnosus (strain Lcr 35 LC)
    Patients will be blindly randomized to be assigned to a 5 weeks regimen with the probiotic or to a 5 weeks regimen with placebo.


Primary Outcome Measures :
  1. Reduction of the duration of Vancomycin Resistant Enterococcus intestinal carriage.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18;
  • Vancomycin Resistant Enterococcus intestinal carriage

Exclusion Criteria:

  • Neutropenia <1000 /mm3,
  • Immunosuppressive drugs,
  • Inhalation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437580


Contacts
Contact: Olivier LESENS olesens@chu-clermontferrand.fr

Locations
France
Service des Maladies infectieuses et tropicales Recruiting
Hôpital Gabriel Montpied, Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Olivier LESENS University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Olivier LESENS, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00437580     History of Changes
Other Study ID Numbers: CHU63-0015
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: January 2011

Keywords provided by University Hospital, Clermont-Ferrand:
Vancomycin Resistant Enterococcus, probiotic

Additional relevant MeSH terms:
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents