Actively Recruiting
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women with Recurrent Urinary Tract Infections
Led by Hadassah Medical Organization · Updated on 2025-03-19
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether differences in the vaginal, urinary, and fecal microbiomes may make postmenopausal women more likely to have repeated urinary tract infections (UTIs). This observational study compares microbiome profiles between women with recurrent UTIs and age-matched women without such infections to better understand the factors involved. Women who have had two or more culture-confirmed UTIs in the last six months or three or more in the past year will be compared to healthy menopausal women without prior UTIs or urinary abnormalities. Samples including vaginal, urine, and fecal matter will be collected during clinic visits after at least one month without antibiotics. For women with UTIs, additional samples are taken during an acute infection episode. Control participants will be examined once. Participants will provide medical history and undergo gynecological exams as part of their clinic visits. Researchers will analyze the collected samples using molecular methods to characterize the microbiomes over one year. Urine tests, including cultures and urinalysis, will also be performed. The study monitors participants without administering any treatment and aims to deepen understanding of microbiome roles in recurrent UTIs.
CONDITIONS
Brief Title
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women with Recurrent Urinary Tract Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Menopausal status
- Two or more documented, culture-positive infections in the last six months or three or more infections in the last year (for patients)
- Menopausal status (for control subjects)
- Sterile urine cultures, normal urinalysis, and negative sexually-transmitted PCR urine assay (for control subjects)
You will not qualify if you...
- Neurogenic bladder condition
- Known immunodeficiencies
- Usage of antibiotics or probiotics within the previous month
- Known renal calculi or anatomic malformations
- Prior history of urinary tract infections or other urologic abnormalities (for control subjects)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants provide vaginal, urine, and fecal samples for microbiome molecular analysis during clinic visits. Urine is also collected for urinalysis and culture. Samples are collected when participants have not taken antibiotics for at least one month. For patients with recurrent urinary tract infections, additional samples are collected during an acute UTI episode.
Clinic visits as needed for sample collection, including during acute UTI episodes for patients
Trial Site Locations
Total: 1 location
1
Hadassah Medical Center
Jerusalem, Jerusalem, Israel, 9765422
Actively Recruiting
Research Team
A
Ahinoam Lev-Sagie, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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