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Could a probiotic plus smart antibiotic use end the cycle of recurrent UTIs in children?

NCT ID NCT06149676

Prevention Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This early-phase trial tests whether taking a daily probiotic (Saccharomyces boulardii) and using a targeted antibiotic (ciprofloxacin) only when a UTI occurs can reduce the number of repeat infections in children aged 2 to 17. Participants have had at least three UTIs in the past year or two in the last six months. The study compares this approach to standard care to see if it lowers future UTI episodes.

What this could mean

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

Active substance
Saccharomyces boulardii (probiotic) and ciprofloxacin (antibiotic)
What this could lead to
If it works, this could offer a new way to prevent frequent UTIs in children without long-term daily antibiotics.
What could go wrong
This is a very early, small trial (35 participants) so results may not apply broadly. The approach depends on the infection being sensitive to ciprofloxacin, which may not always be the case.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

35 people

The number who actually took part.

Started

Feb 2022

Finished

Dec 2025

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

2 to 17 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * A history of 3 or more UTI episodes in the past 12 months, or 2 or more episodes in the past 6 months * no evidence of vesicoureteral reflux or only low-grade (grade 1-2) vesicoureteral reflux * no other genitourinary anatomical abnormality * not receiving prophylactic antibiotics at the time of enrollment * Ages 2-17 years. Exclusion Criteria: * high grade (grade 3-5) vesicoureteral reflux * neurogenic bladder * anatomical abnormalities of the gastrointestinal tract * any history of urologic or gastrointestinal surgery * on prophylactic antibiotics * a urine culture positive for pathogens that are not susceptible to ciprofloxacin in the last 3 months * history of an allergic reaction to ciprofloxacin or other quinolones, or a history of severe adverse reactions * As stated on the package insert for Ciprofloxacin, individuals with a known history of myasthenia gravis should avoid taking Ciprofloxacin and therefore will be excluded from this study. * Based on the black box warning for Ciprofloxacin, individuals taking tizanidine as concomitant administration, or those taking other drugs known to interact with ciprofloxacin will be excluded from the study. * individuals with known QT prolongation, hypokalemia, or on other drugs that prolong the QT interval should also avoid taking Ciprofloxacin and will be excluded from this study. * Individuals under 2 years old. In the BFIT clinic, because they do bladder, bowel movement, and constipation management, it is harder to manage if the patient is not potty trained. Therefore, we are excluding participants under 2 years of age.

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Conditions

The condition(s) this trial relates to.

bacterial urinary tract infection 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.

Recurrent UTI

Contacts and locations

Locations

  • Lurie Children's Hospital

    Chicago, Illinois, 60611, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.