Characterization of Vaginal, Urinary and Fecal Microbiomes in Women with Recurrent Urinary Tract Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Urinary Tract Infections, Menopause. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Characterization of the microbiome using molecular methods. [Time frame: 1 year]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Israel · 1 center
- Hadassah Medical Center — Jerusalem
Identifiers
NCT: NCT04305808 · 0014-20-HMO