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

Sponsors and Collaborators:	University Hospital, Clermont-Ferrand University Hospital
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00437580

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 IV

Drug Information available for: Lactobacillus casei Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

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.

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, Clermont-Ferrand
Service des Maladies infectieuses et tropicales	Recruiting
Hôpital Gabriel Montpied, Clermont-Ferrand, France, 63003

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

University Hospital

Investigators

Principal Investigator:

Olivier LESENS

University Hospital, Clermont-Ferrand

More Information

No publications provided

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

Keywords provided by University Hospital, Clermont-Ferrand:

Vancomycin Resistant Enterococcus, probiotic

Study placed in the following topic categories:

Vancomycin

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 11, 2009