NCT04305808 Characterization of Vaginal, Urinary and Fecal Microbiomes in Women with Recurrent Urinary Tract Infections
| NCT ID | NCT04305808 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hadassah Medical Organization |
| Condition | Urinary Tract Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-08-01 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2021-08-01 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Ahinoam Lev-Sagie, MD
PRINCIPAL INVESTIGATOR
Hadassah Medical Organization
Frequently Asked Questions
Who can join the NCT04305808 clinical trial?
This trial is open to female participants only, studying Urinary Tract Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04305808 currently recruiting?
Yes, NCT04305808 is actively recruiting participants. Contact the research team at levsagie@netvision.net.il for enrollment information.
Where is the NCT04305808 trial being conducted?
This trial is being conducted at Jerusalem, Israel.
Who is sponsoring the NCT04305808 clinical trial?
NCT04305808 is sponsored by Hadassah Medical Organization. The principal investigator is Ahinoam Lev-Sagie, MD at Hadassah Medical Organization. The trial plans to enroll 40 participants.