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Sponsors and Collaborators: |
University Hospital, Clermont-Ferrand University Hospital |
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Information provided by: | University Hospital, Clermont-Ferrand |
ClinicalTrials.gov Identifier: | NCT00437580 |
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 | Intervention | Phase |
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Vancomycin Resistant Enterococcus Intestinal Carriage |
Drug: Lactobacillus casei rhamnosus (strain Lcr 35 LC) |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Impact of Probiotic Regimen on Vancomycin Resistant Enterococcus (VRE) Intestinal Carriage : a Double Blind Randomized Pilot Study. |
Estimated Enrollment: | 24 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Olivier LESENS | olesens@chu-clermontferrand.fr |
France, Clermont-Ferrand | |
Service des Maladies infectieuses et tropicales | Recruiting |
Hôpital Gabriel Montpied, Clermont-Ferrand, France, 63003 |
Principal Investigator: | Olivier LESENS | University Hospital, Clermont-Ferrand |
Responsible Party: | CHU Clermont-Ferrand ( Olivier LESENS ) |
Study ID Numbers: | CHU63-0015 |
Study First Received: | February 19, 2007 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00437580 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Vancomycin Resistant Enterococcus, probiotic |
Vancomycin |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |