Status:
RECRUITING
Microbiome-Modulating Prophylaxis RCT: Antibiotic vs Gynoflor in Postmenopausal Women With Recurrent Cystitis
Lead Sponsor:
Mahidol University
Conditions:
Cystitis, Recurrent
Urinary Tract Infections
Eligibility:
FEMALE
40+ years
Phase:
PHASE4
Brief Summary
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 10...
Detailed Description
Background and Rationale Recurrent cystitis is common after menopause and burdens quality of life and healthcare use. Antibiotic prophylaxis is effective but may promote antimicrobial resistance with...
Eligibility Criteria
Inclusion
- 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 to provide written informed consent
- Willing and able to complete twice-weekly phone/LINE follow-ups
Exclusion
- Current symptomatic UTI at enrollment (may be treated and reconsidered after resolution)
- Known hypersensitivity or contraindication to nitrofurantoin or to the Lactobacillus/estriol vaginal tablet (Gynoflor) or their excipients; significant renal impairment or other label-based contraindications to nitrofurantoin per local practice
- Planned urologic surgery or procedure expected during the 6-month study period
- Recent bacterial vaginosis (e.g., within the past month) or active vulvovaginal skin disorders precluding vaginal product use
- History of hormone-dependent malignancy (e.g., breast, uterine, or cervical cancer) or unexplained abnormal vaginal bleeding
- Significant liver disease (e.g., active hepatitis) or other conditions judged by the investigator to make participation unsafe
- Participation in another interventional trial that could interfere with outcomes
- Withdrawal of consent or severe adverse event requiring discontinuation
Key Trial Info
Start Date :
September 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07186465
Start Date
September 11 2025
End Date
August 30 2026
Last Update
September 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Faculty of Medicine Ramathibodi Hospital Mahidol University
Bangkok, Phayatai Ratchathewi, Thailand, 10400