Effect of Lactobacilli on Bacterial Composition and Cystitis in Postmenopausal Women
The Effect on Bacterial Composition in Urine, Vagina and Faces After Treatment With Lactobacilli and Its Influence on Recurrent Cystitis in Postmenopausal Women.
This study is testing if taking lactobacilli can change the bacteria in the urine, vagina, and feces of postmenopausal women to help prevent repeated bladder infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Aalborg University Hospital Academic / other |
| Locations | 1 site (Aalborg, Region Nord) |
| Trial ID | NCT05591742 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how treatment with lactobacilli affects the bacterial composition in the urine, vagina, and feces of postmenopausal women and its potential to prevent recurrent cystitis. Participants will receive either a placebo or lactobacilli tablets in a crossover design, allowing each participant to serve as their own control. The study will follow participants for six months to assess changes in microbiome composition and the incidence of cystitis episodes. The primary focus is on understanding the relationship between lactobacilli treatment and urinary microbiome alterations.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women with a verified diagnosis of recurrent cystitis.
Not a fit: Patients with bladder diseases, cancer, or those currently using antibiotics or probiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment option for preventing recurrent cystitis in postmenopausal women.
How similar studies have performed: While the specific approach of using lactobacilli for recurrent cystitis in this population is novel, similar studies have shown promise in modifying the microbiome to improve urinary health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * postmenopausal women * if hysterectomy before menopause, then age of \>60 years * verified diagnose of recurrent cystitis. (two in 6 months or 3 in a year, verified by cultivation) * able to speak and write Danish Exclusion Criteria: * vaginal prolapse with symptoms * residual urine over 150 ml * bladder diseases * profylactic antibiotics * probiotics * bladder cancer * genital cancer.
Where this trial is running
Aalborg, Region Nord
- AalborgH — Aalborg, Region Nord, Denmark (Recruiting)
Study contacts
- Principal investigator: Caroline S Juhl — Aalborg University Hospital
- Study coordinator: Caroline S Juhl, SR
- Email: c.juhl@rn.dk
- Phone: 0045 30287929
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.