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

Recruiting

• Conditions: Urinary Tract Infections; Menopause

• Registration Number: NCT04305808
• Lead Sponsor: Hadassah Medical Organization

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.

Study Timeline

• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-12
• Study Start: 2021-08-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-15
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel