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Microbiome-Modulating Prophylaxis RCT: Antibiotic vs Gynoflor in Postmenopausal Women With Recurrent Cystitis

RecruitingPhase 4Ages 40 Years - anyFemaleMahidol University
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In plain words

What the trial is, and whether it could suit you

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 (โ‰ฅ40 years) are randomized 1:1 in computer-generated blocks and followed for 6 months. The primary endpoint is the proportion with rUTI recurrence within 6 months. Secondary endpoints include time to first recurrence, antibiotic resistance in breakthrough infections, change in lower urinary tract symptoms (Thai RUTISS), and urinary microbiome measures (Lactobacillus dominance and community diversity by qPCR and 16S rRNA). Key assessments occur at baseline and month 6 (urinalysis, culture, urinary microbiome sampling, an

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Female, postmenopausal, age โ‰ฅ40 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 Criteria: * 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
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What it tests

  • Nitrofurantoin
  • Gynoflor
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Where

1 site
Faculty of Medicine Ramathibodi Hospital Mahidol University
Bangkok, Thailand
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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