Evaluating Urinary Microbiome Modulation :An RCT of Antibiotic vs Gynoflor Prophylaxis in Postmenopausal Women With Recurrent Cystitis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 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 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, and kidney function). Adherence and adverse events are captured via twice-weekly phone/Line contacts. Approximately 100 participants (50 per arm) will be enrolled as a feasibility-sized pilot.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Thailand
Faculty of Medicine Ramathibodi Hospital Mahidol University
RECRUITING
Bangkok
Contact Information
Primary
Lappanawat Santitham
cambellabios@gmail.com
+66944314994
Time Frame
Start Date: 2025-09-11
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 100
Treatments
Active_comparator: Nitrofurantoin Prophylaxis
Nightly oral nitrofurantoin 100 mg for 6 months as prophylaxis for recurrent UTI in postmenopausal women. If symptomatic UTI occurs, treat per standard care and, once resolved, continue assigned prophylaxis to complete 6 months. Monitoring per protocol: baseline and month-6 visits with urinalysis, urine culture, urinary microbiome, and kidney function; twice-weekly phone/Line check-ins for adherence, symptoms, and adverse events.
Experimental: Gynoflor Vaginal Tablet
Vaginal tablet containing Lactobacillus with ultra-low-dose estriol (Gynoflor) for 6 months: insert 1 tablet nightly for 14 days, then twice weekly through month 6. Same monitoring and management as comparator: if UTI occurs, treat per standard care and then resume assigned prophylaxis to finish 6 months.
Related Therapeutic Areas
Sponsors
Leads: Mahidol University

This content was sourced from clinicaltrials.gov