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A Study of Vaginal MicroFlora and Immune Profiles of Patients With Recurrent Urinary Tract Infection

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ClinicalTrials.gov Identifier: NCT00216853
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 16, 2009
Sponsor:
Collaborator:
Natural Sciences and Engineering Research Council, Canada
Information provided by:
Lawson Health Research Institute

Study Description
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Brief Summary:
The purpose of this study is to determine the extent to which vaginal microflora and immune profiles of patients with urinary tract infection (UTI) differ from healthy controls.

Condition or disease
Urinary Tract Infections

Detailed Description:
Recurrent urinary tract infections, which occur mostly in the female population, can be potentially harmful if not treated and significantly reduce quality of life. By characterizing the vaginal microflora and immune profiles of women that suffer recurrent UTIs in contrast to a healthy age matched normal group of women (with no history of recurrent UTIs), we can better understand the differences. This in turn can lead to development of better quality probiotics that will be based on their scientific basis, clinical efficacy, and quality in terms of shelf life and delivery to target sites. The reduction in only one third of UTI cases seen each year would have a significant impact on reducing health care costs.
Study Design
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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of Vaginal MicroFlora and Immune Profiles of Patients With Recurrent Urinary Tract Infection
Study Start Date : September 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : March 2007

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Groups and Cohorts
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Group/Cohort
Patients with Recurrent UTI
Healthy controls


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Criteria

Inclusion Criteria:

Inclusion Criteria for UTI Group:

  1. At least 2 recurrent UTIs within the last year
  2. Written informed consent

Inclusion Criteria for Normal Group:

  1. No UTI within the past 5 years
  2. Written informed consent

Exclusion Criteria:

Exclusion Criteria for Both Groups:

  1. Active UTI
  2. Urinary tract anomalies
  3. Evidence of a neurogenic bladder
  4. Known immunodeficiencies
  5. Use of antibiotics, within the last month
  6. Concomitant use of oral steroids
  7. Known renal calculi
  8. Previous or ongoing chemotherapy
  9. Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216853


Locations
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Canada, Ontario
St. Joseph's Health Centre
London, Ontario, Canada
Sponsors and Collaborators
Lawson Health Research Institute
Natural Sciences and Engineering Research Council, Canada
Investigators
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Principal Investigator: Stephen Pautler, MD, FRCSC Lawson Health Research Institute
More Information
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Responsible Party: Dr S. Pautler, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00216853    
Other Study ID Numbers: R-03-202
9875E
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 16, 2009
Last Verified: April 2009
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Urinary Tract Infections
 Disease Attributes
Pathologic Processes
Urologic Diseases