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

NCT ID: NCT00216853

Last Updated: 2009-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-09-30

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urinary Tract Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Recurrent UTI

No interventions assigned to this group

Healthy controls

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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


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

Exclusion Criteria

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Natural Sciences and Engineering Research Council, Canada

OTHER

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Lawson Health Research Institute

Principal Investigators

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Stephen Pautler, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

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St. Joseph's Health Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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9875E

Identifier Type: -

Identifier Source: secondary_id

R-03-202

Identifier Type: -

Identifier Source: org_study_id

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