Actively Recruiting

Phase 4
Age: 40Years +
FEMALE
NCT07186465

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

Led by Mahidol University · Updated on 2025-09-25

100

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female, postmenopausal, age 40 years or older
  • Clinical history of recurrent urinary tract infection 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
Not Eligible

You will not qualify if you...

  • Current symptomatic urinary tract infection at enrollment (may be treated and reconsidered after resolution)
  • Known hypersensitivity or contraindication to nitrofurantoin or the Lactobacillus/estriol vaginal tablet or their ingredients
  • Significant renal impairment or other contraindications to nitrofurantoin per local practice
  • Planned urologic surgery or procedure expected during the 6-month study period
  • Recent bacterial vaginosis within the past month or active vulvovaginal skin disorders preventing vaginal product use
  • History of hormone-dependent cancers or unexplained abnormal vaginal bleeding
  • Significant liver disease or other conditions making participation unsafe
  • Participation in another interventional trial that could affect outcomes
  • Withdrawal of consent or severe adverse events requiring stopping participation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Faculty of Medicine Ramathibodi Hospital Mahidol University

Bangkok, Phayatai Ratchathewi, Thailand, 10400

Actively Recruiting

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Research Team

L

Lappanawat Santitham

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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