Impact of Probiotic Regimen on Vancomycin Resistant Enterococcus Intestinal Carriage

NCT ID: NCT00437580

Last Updated: 2011-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-08-31

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.

Conditions

Vancomycin Resistant Enterococcus Intestinal Carriage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age >18;
• Vancomycin Resistant Enterococcus intestinal carriage

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

CHU Clermont-Ferrand

Principal Investigators

Olivier LESENS

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

Service des Maladies infectieuses et tropicales

Hôpital Gabriel Montpied, Clermont-Ferrand, France

Site Status: RECRUITING

Countries

France

Central Contacts

Olivier LESENS

Role: CONTACT

olesens@chu-clermontferrand.fr

References

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. doi: 10.1128/JCM.00473-10. Epub 2010 Apr 26.

Reference Type: DERIVED

PMID: 20421444 (View on PubMed)

Other Identifiers

CHU63-0015

Identifier Type: -

Identifier Source: org_study_id