Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections

Menopause Clinical Trial

Official title:

Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04305808
• Other study ID #: 0014-20-HMO
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Hadassah Medical Organization
• Contact: Ahinoam Lev-Sagie, MD
• Phone: 97225844000
• Email: levsagie[@]netvision.net.il
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Menopause
• Urinary Tract Infections

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of the microbiome using molecular methods.	Comparison of microbiome profiles between those with rUTI compared to healthy controls.	1 year