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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04305808
Study type Observational
Source Hadassah Medical Organization
Contact Ahinoam Lev-Sagie, MD
Phone 97225844000
Email levsagie@netvision.net.il
Status Recruiting
Phase
Start date August 1, 2021
Completion date December 30, 2024

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