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

L

Lawson Health Research Institute

Status

Completed

Conditions

Urinary Tract Infections

Study type

Observational

Funder types

Other

Identifiers

NCT00216853
R-03-202
9875E

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

Female

Ages

20 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

44 participants in 2 patient groups

Patients with Recurrent UTI
Healthy controls

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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