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Impact of Probiotic Regimen on Vancomycin Resistant Enterococcus Intestinal Carriage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00437580
First received: February 19, 2007
Last updated: January 18, 2011
Last verified: January 2011
  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:


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:
    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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014