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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216853
• Other study ID #: R-03-202
• Secondary ID: 9875E
• Status: Completed
• Phase: N/A
• First received: September 19, 2005
• Last updated: April 15, 2009
• Start date: September 2003
• Est. completion date: March 2007

Study information

• Verified date: April 2009
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2007
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection
• Urinary Tract Infections

Locations

Country	Name	City	State
Canada	St. Joseph's Health Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Natural Sciences and Engineering Research Council, Canada

Country where clinical trial is conducted

Canada,