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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04305808

Enrollment

Registered

2020-03-12

Start date

2021-08-01

Completion date

2025-12-30

Last updated

2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause, Urinary Tract Infections

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

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-

Design outcomes

Primary

Measure	Time frame	Description
Characterization of the microbiome using molecular methods.	1 year	Comparison of microbiome profiles between those with rUTI compared to healthy controls.

Countries

Israel

Contacts

Primary ContactAhinoam Lev-Sagie, MD

levsagie@netvision.net.il97225844000

Outcome results