Examining the microbiomes of women with recurrent urinary tract infections
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women with Recurrent Urinary Tract Infections
Hadassah Medical Organization · NCT04305808
This study is trying to see if differences in the bacteria found in the bodies of postmenopausal women can help explain why some of them keep getting urinary tract infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Sex | Female |
| Sponsor | Hadassah Medical Organization (other) |
| Locations | 1 site (Jerusalem, Jerusalem) |
| Trial ID | NCT04305808 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the relationship between variations in vaginal, urinary, and fecal microbiomes and the predisposition to recurrent urinary tract infections (UTIs) in postmenopausal women. Participants with a history of recurrent UTIs will be compared to age-matched controls without such history. The study involves collecting microbiome samples and conducting a thorough medical history intake and gynecological examination. The goal is to identify potential microbiome profiles that may contribute to recurrent UTIs.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women with a history of recurrent urinary tract infections.
Not a fit: Patients with neurogenic bladder conditions, known immunodeficiencies, or those who have used antibiotics or probiotics within the previous month may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of recurrent urinary tract infections in postmenopausal women.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated that microbiome variations can influence urinary tract infection susceptibility, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jerusalem, Jerusalem
- Hadassah Medical Center — Jerusalem, Jerusalem, Israel (RECRUITING)
Study contacts
- Principal investigator: Ahinoam Lev-Sagie, MD — Hadassah Medical Organization
- Study coordinator: Ahinoam Lev-Sagie, MD
- Email: levsagie@netvision.net.il
- Phone: 97225844000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urinary Tract Infections, Menopause