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NCT Number: NCT04305808

Characterization of Vaginal, Urinary and Fecal Microbiomes in Women with Recurrent Urinary Tract Infections

The objectives are to evaluate whether variations in vaginal and/or urinary and/or fecal microbiome predispose postmenopausal women to recurrent cystitis. This will be explored using comparison of microbiome profiles between those with recurrent UTI compared to age-matched women without recurrent UTI.

Recruiting

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Hadassah Medical Center

Jerusalem, 9765422, Israel

Location status: Recruiting

Location contact

Ahinoam Lev-Sagie, MD

CONTACT

About this study

Patients and age-matched control subjects will be recruited from the Urogynecology clinic in Hadassah Mt Scopus and the gynecology clinic, respectively.

After assessment of inclusion and exclusion criteria and patient's consent to participate, a history intake (detailing demographics, medical history, risk factors for rUTI etc.) and gynecological examination will be conducted as part of the usual assessment in the clinic.

Vaginal, urine and fecal samples for microbiome molecular analysis will be collected during clinic visits, given at least one month without antibiotics before samples collection, using agreed protocols and will be kept for future evaluation. Urine will be collected for urinalysis and for a urine culture.

In addition, urine cultures, as well as vaginal, urine and fecal samples for molecular analysis will be collected during an acute UTI episode from the same patients.

Healthy patients (the control group) will be examined only once.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Patients' inclusion criteria:

  • Menopausal status
  • Two or more documented, culture-positive infections in the last six months or ≥3 infections in the last year Patients' exclusion criteria
  • Neurogenic bladder condition
  • Known immunodeficiencies
  • Usage of antibiotics or probiotics within the previous month
  • Known renal calculi or anatomic malformations

Control subjects- Inclusion criteria:

  • Menopausal status
  • Sterile urine cultures, normal urinalysis, and negative sexually-transmitted PCR urine assay

Control subjects- Exclusion criteria:

  • A prior history of UTIs or other urologic abnormalities.

Treatment and study plan

Primary outcomes

  1. Characterization of the microbiome using molecular methods.

    Time frame: 1 year

    Comparison of microbiome profiles between those with rUTI compared to healthy controls.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahinoam Lev-Sagie, MD

CONTACT

[email protected]

97225844000

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2020
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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