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

Hadassah Medical Center

Status: Enrolling

Conditions: Urinary Tract Infections; Menopause

Study type: Observational

Funder types: Other

Identifiers

NCT04305808

0014-20-HMO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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- Exclusion criteria:

• A prior history of UTIs or other urologic abnormalities.

Trial design

40 participants in 2 patient groups

Recurrent Urinary tract infection

Description:

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

Healthy controls

Description:

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