Microbiome-Modulating Prophylaxis RCT: Antibiotic vs Gynoflor in Postmenopausal Women With Recurrent Cystitis
Recruiting
Phase 4
Interventional Study
Cystitis, Recurrent
Urinary Tract Infections
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 40 and older
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 100 (estimated)
- Sponsor
- Mahidol University · Other
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About This Trial
This open-label, parallel-group randomized controlled trial compares two prophylaxis strategies for recurrent urinary tract infection (rUTI) in postmenopausal women: (1) nightly oral nitrofurantoin 100 mg for 6 months versus (2) a vaginal tablet containing Lactobacillus with ultra-low-dose estriol (Gynoflor: nightly for 14 days, then twice weekly to month 6). Participants (≥40 years) are randomize…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Female, postmenopausal, age ≥40 years
* Clinical history of recurrent urinary tract infection (rUTI) as assessed by the investigator
* Able and willing to take assigned prophylaxis for 6 months
* Able to attend baseline and Month 6 study visits and provide urine samples
* Able…
Contacts