[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100385983":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":19,"interventions":13,"overallOfficials":26,"centralContacts":30,"locations":35,"responsibleParty":51,"collaborators":13,"id":54,"slug":13,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":13,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":13,"maxAge":13,"enrollmentInfo":61,"targetDuration":13,"studyType":64,"phases":13,"briefSummary":65,"conditions":66,"keywords":13,"overallStatus":38,"whyStopped":13,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Hadassah Medical Organization","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Characterization of the microbiome using molecular methods.","Comparison of microbiome profiles between those with rUTI compared to healthy controls.","1 year",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","Patients and age-matched control subjects will be recruited from the Urogynecology clinic in Hadassah Mt Scopus and the gynecology clinic, respectively.\n\nAfter 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.\n\nVaginal, 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.\n\nIn 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.\n\nHealthy patients (the control group) will be examined only once.","Menopausal women, with recurrent UTI and age-matched menopausal women without recurrent UTI.",[20,23],{"label":21,"type":13,"description":22,"interventionNames":13},"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",{"label":24,"type":13,"description":25,"interventionNames":13},"Healthy controls","Menopausal women, without prior history of UTIs or other urologic abnormalities.",[27],{"name":28,"affiliation":5,"role":29},"Ahinoam Lev-Sagie, MD","PRINCIPAL_INVESTIGATOR",[31],{"name":28,"role":32,"phone":33,"phoneExt":13,"email":34},"CONTACT","97225844000","levsagie@netvision.net.il",[36],{"facility":37,"status":38,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hadassah Medical Center","RECRUITING","Jerusalem","9765422","Israel","IL",{"type":44,"coordinates":45},"Point",[46,47],35.21633,31.76904,{"lat":47,"lon":46},[50],{"name":28,"role":32,"phone":13,"phoneExt":13,"email":13},{"type":29,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"Ahinoam Lev-Sagie","MD","100385983",false,"NCT04305808","Characterization of Vaginal, Urinary and Fecal Microbiomes in Women with Recurrent Urinary Tract Infections","Patients' inclusion criteria:\n\n* Menopausal status\n* Two or more documented, culture-positive infections in the last six months or ≥3 infections in the last year Patients' exclusion criteria\n* Neurogenic bladder condition\n* Known immunodeficiencies\n* Usage of antibiotics or probiotics within the previous month\n* Known renal calculi or anatomic malformations\n\nControl subjects- Inclusion criteria:\n\n* Menopausal status\n* Sterile urine cultures, normal urinalysis, and negative sexually-transmitted PCR urine assay\n\nControl subjects- Exclusion criteria:\n\n\\- A prior history of UTIs or other urologic abnormalities.",true,"FEMALE",{"count":62,"type":63},40,"ESTIMATED","OBSERVATIONAL","The objectives are to evaluate whether variations in vaginal and\u002For urinary and\u002For 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.",[67,68],"Urinary Tract Infections","Menopause","2025-03-15",{"date":71,"type":72},"2025-03-19","ACTUAL",{"date":74,"type":72},"2021-08-01",{"date":76,"type":63},"2025-12-30",{"name":5,"class":6},1]