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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • St. Joseph's Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy controls
Patients with Recurrent UTI

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Natural Sciences and Engineering Research Council, Canada
• Investigators: Principal Investigator: Stephen Pautler, MD, FRCSC, Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: September 19, 2005
• First Submitted That Met QC Criteria: September 19, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): April 16, 2009
• Last Update Submitted That Met QC Criteria: April 15, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: R-03-202; 9875E