Ignite Creation Date:
2024-05-06 @ 2:23 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04305808
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2020-03-10
Brief Title:
Characterization of Vaginal Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Characterization of Vaginal Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objectives are to evaluate whether variations in vaginal andor urinary andor 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 patients 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
After assessment of inclusion and exclusion criteria and patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None