A Novel Probiotic-antibiotic Combination to Prevent Recurrent Urinary Tract Infections

NCT ID: NCT06149676

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2025-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Probiotic with or without antibiotic

All patients will receive probiotics for this, only those with a UTI will get ciprofloxacin.

Group Type: EXPERIMENTAL

Saccharomyces Boulardii 250 MG [Florastor]

Intervention Type: DRUG

All patients will get the probiotic to be taken daily. If UTI occurs with a sensitive pathogen, we will treat with ciprofloxacin

Control

Patients will get standard of care treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Saccharomyces Boulardii 250 MG [Florastor]

All patients will get the probiotic to be taken daily. If UTI occurs with a sensitive pathogen, we will treat with ciprofloxacin

Intervention Type: DRUG

Other Intervention Names

ciprofloxacin

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Mehreen Arshad

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehreen Arshad

Role: PRINCIPAL_INVESTIGATOR

Lurie Children's Hospital

Locations

Lurie Children's Hospital

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mehreen Arshad, MD

Role: CONTACT

marshad@luriechildrens.org

3122274080

Facility Contacts

Mehreen Arshad

Role: primary

marshad@luriechildrens.org

312-227-4080

Other Identifiers

IRB 2022-4941

Identifier Type: -

Identifier Source: org_study_id