Recurrent UtiEarly Phase 1NCT06149676
A Novel Probiotic-antibiotic Combination to Prevent Recurrent Urinary Tract Infections
A Early Phase 1 study testing Saccharomyces Boulardii 250 MG [Florastor] in people with Recurrent Uti, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
Patients with recurrent UTI were randomized to receive either the probiotic Sacchromyces Boulardii at enrollment, and the intracellularly active Ciprofloxacin with their first UTI episode after enrollment, or they received standard of care treatment. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Uti
- What is being tested?
- Saccharomyces Boulardii 250 MG [Florastor]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2022to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Patients with recurrent UTI were randomized to receive either the probiotic Sacchromyces Boulardii at enrollment, and the intracellularly active Ciprofloxacin with their first UTI episode after enrollment, or they received standard of care treatment.
Read the detailed description
- At the time of consent, participants will be given 20 mg/kg of the antibiotic, ciprofloxacin. If the participant has symptoms of a UTI or have a positive urine culture at enrollment, they will take the antibiotic every 12 hours for 14 days. If the participant does not have symptoms of a UTI at enrollment, the antibiotic will be taken only if needed at home upon the first occurrence of a UTI.
- At the time of consent, participants will also be given 250 mg of the probiotic, S. boulardii, taken once daily for 6 months, irrespective of symptoms.
- Throughout the study, participants will receive their standard clinical care for recurrent UTI treatment, which includes bowel and bladder dysfunction management and other prescribed non-antibiotic interventions at the managing provider's clinical discretion.
- Conditions
- Recurrent Uti
- Being tested
- Saccharomyces Boulardii 250 MG [Florastor]
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharomyces Boulardii 250 MG [Florastor]Drug
Also called ciprofloxacin
All patients will get the probiotic to be taken daily. If UTI occurs with a sensitive pathogen, we will treat with ciprofloxacin
| Study group | Role | What they receive |
|---|---|---|
| Probiotic with or without antibiotic | Experimental | All patients will receive probiotics for this, only those with a UTI will get ciprofloxacin. Receives: Drug: Saccharomyces Boulardii 250 MG [Florastor] |
| Control | No intervention | Patients will get standard of care treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in UTI episodes
We will look for a reduction the number of UTI episodes before and after the intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start2 Feb 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent UtiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehreen Arshad, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Mehreen Arshad, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149676
- Sponsor's protocol ID
- IRB 2022-4941
- Status last verified
- Jun 2026
- First submitted
- 21 Nov 2023
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Probiotic-antibiotic Combination to Prevent Recurrent Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT06149676
- Acronym / sponsor ID
- IRB 2022-4941
- Conditions
- Recurrent Uti
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with recurrent UTI were randomized to receive either the probiotic Sacchromyces Boulardii at enrollment, and the intracellularly active Ciprofloxacin with their first UTI episode after enrollment, or they received standard of care treatment.
Detailed description
- At the time of consent, participants will be given 20 mg/kg of the antibiotic, ciprofloxacin. If the participant has symptoms of a UTI or have a positive urine culture at enrollment, they will take the antibiotic every 12 hours for 14 days. If the participant does not have symptoms of a UTI at enrollment, the antibiotic will be taken only if needed at home upon the first occurrence of a UTI.
- At the time of consent, participants will also be given 250 mg of the probiotic, S. boulardii, taken once daily for 6 months, irrespective of symptoms.
- Throughout the study, participants will receive their standard clinical care for recurrent UTI treatment, which includes bowel and bladder dysfunction management and other prescribed non-antibiotic interventions at the managing provider's clinical discretion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic with or without antibiotic | Experimental | Drug: Saccharomyces Boulardii 250 MG [Florastor]All patients will receive probiotics for this, only those with a UTI will get ciprofloxacin. |
| Control | No intervention | –Patients will get standard of care treatment. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saccharomyces Boulardii 250 MG [Florastor]Also: ciprofloxacinAll patients will get the probiotic to be taken daily. If UTI occurs with a sensitive pathogen, we will treat with ciprofloxacin | Drug | Probiotic with or without antibiotic |
Primary outcome
Reduction in UTI episodes
Time frame: 6 months
We will look for a reduction the number of UTI episodes before and after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Recurrent Uti
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
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Probiotic Supplement for Recurrent UTIs in Healthy Women (L. Plantarum, L. Rhamnosus, B. Lactis)
Recurrent Urinary Tract Infections
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Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women
Recurrent Urinary Tract Infections in Women
Active, not recruiting
Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.
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RecruitingPhase 4
Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study
Urinary Tract Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehreen Arshad principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Saccharomyces Boulardii 250 MG [Florastor] in people with Recurrent Uti, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in UTI episodes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.