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

PHASE4RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 11, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

August 30, 2026

Conditions
Cystitis, RecurrentUrinary Tract Infections
Interventions
DRUG

Nitrofurantoin

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.

DRUG

Gynoflor

Vaginal tablet containing Lactobacillus with ultra-low-dose estriol. Insert 1 tablet nightly for 14 days, then twice weekly through month 6 as prophylaxis against recurrent urinary tract infection. If a symptomatic UTI occurs, treat per standard of care; after resolution, continue assigned prophylaxis to complete 6 months. Monitoring identical to comparator.

Trial Locations (1)

10400

RECRUITING

Faculty of Medicine Ramathibodi Hospital Mahidol University, Bangkok

All Listed Sponsors
lead

Mahidol University

OTHER