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Could a vaginal probiotic replace antibiotics for recurrent UTIs?

NCT ID NCT07186465

Disease control Sponsor: Mahidol University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study compares two ways to prevent repeat urinary tract infections (UTIs) in women after menopause. One group takes a nightly antibiotic pill for 6 months, while the other uses a vaginal tablet containing a probiotic (Lactobacillus) and a tiny amount of estrogen. The goal is to see which approach better prevents infections and how they affect the urinary microbiome. About 100 women will participate for 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nitrofurantoin (antibiotic) and Gynoflor (vaginal tablet containing Lactobacillus with ultra-low-dose estriol)
What this could lead to
If it works, this could point toward a non-antibiotic option to prevent recurrent UTIs in postmenopausal women, reducing antibiotic use and resistance.
What could go wrong
This is a small pilot study (100 participants) and may not provide definitive answers. The probiotic approach may be less effective than antibiotics, and individual results may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 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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Conditions

The condition(s) this trial relates to.

chronic cystitis cystitis Lower Urinary Tract Symptoms Recurrence urinary tract infection urinary tract infections, recurrent, susceptibility to

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystitis recurrent Urinary tract infections

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Faculty of Medicine Ramathibodi Hospital Mahidol University

    RECRUITING

    Bangkok, Phayatai Ratchathewi, 10400, Thailand

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