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

NCT ID: NCT04305808

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2025-12-30

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.

Conditions

Urinary Tract Infections; Menopause

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Recurrent Urinary tract infection

Menopausal women, with two or more documented, culture-positive infections in the last six months or ≥3 infections in the last year

No interventions assigned to this group

Healthy controls

Menopausal women, without prior history of UTIs or other urologic abnormalities.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Menopausal status

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

Exclusion Criteria

• Neurogenic bladder condition
• Known immunodeficiencies
• Usage of antibiotics or probiotics within the previous month
• Known renal calculi or anatomic malformations

• A prior history of UTIs or other urologic abnormalities.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Ahinoam Lev-Sagie

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahinoam Lev-Sagie, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Medical Center

Jerusalem, Jerusalem, Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ahinoam Lev-Sagie, MD

Role: CONTACT

levsagie@netvision.net.il

97225844000

Facility Contacts

Ahinoam Lev-Sagie, MD

Role: primary

Other Identifiers

0014-20-HMO

Identifier Type: -

Identifier Source: org_study_id