Impact of Probiotic Regimen on Vancomycin Resistant Enterococcus Intestinal Carriage - Full Text View

Purpose

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
Vancomycin Resistant Enterococcus Intestinal Carriage	Drug: Lactobacillus casei rhamnosus (strain Lcr 35 LC)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver)
Official Title:	Impact of Probiotic Regimen on Vancomycin Resistant Enterococcus (VRE) Intestinal Carriage : a Double Blind Randomized Pilot Study

Resource links provided by NLM:

Drug Information available for: Vancomycin Vancomycin hydrochloride Lactobacillus

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

Reduction of the duration of Vancomycin Resistant Enterococcus intestinal carriage.

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)

Intervention Details:

Patients will be blindly randomized to be assigned to a 5 weeks regimen with the probiotic or to a 5 weeks regimen with placebo.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age >18;
Vancomycin Resistant Enterococcus intestinal carriage

Exclusion Criteria:

Neutropenia <1000 /mm3,
Immunosuppressive drugs,
Inhalation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided by University Hospital, Clermont-Ferrand

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vidal M, Forestier C, Charbonnel N, Henard S, Rabaud C, Lesens O. Probiotics and intestinal colonization by vancomycin-resistant enterococci in mice and humans. J Clin Microbiol. 2010 Jul;48(7):2595-8. Epub 2010 Apr 26.

Responsible Party:	Olivier LESENS, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00437580 History of Changes
Other Study ID Numbers:	CHU63-0015
Study First Received:	February 19, 2007
Last Updated:	January 18, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Clermont-Ferrand:

Vancomycin Resistant Enterococcus, probiotic

Additional relevant MeSH terms:

Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013