Probiotic and antibiotic treatment to prevent recurrent urinary tract infections

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

This study is testing if a combination of a probiotic and an antibiotic can help children aged 2-17 with a history of recurrent urinary tract infections have fewer infections compared to standard care.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 2 Years to 17 Years
• Sex: All
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago (other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06149676 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a combination of the probiotic Saccharomyces Boulardii and the antibiotic ciprofloxacin in preventing recurrent urinary tract infections (UTIs) in children aged 2-17 years. Participants with a history of recurrent UTIs will be randomized to receive either the probiotic and antibiotic treatment or standard care. The probiotic will be administered daily for six months, while the antibiotic will be given as needed based on UTI symptoms or positive urine cultures. The study aims to evaluate whether this novel combination can reduce the frequency of recurrent UTIs compared to standard treatment.

Who should consider this trial

Good fit: Ideal candidates are children aged 2-17 years with a history of three or more UTI episodes in the past year or two or more episodes in the past six months.

Not a fit: Patients with high-grade vesicoureteral reflux, neurogenic bladder, or those currently on prophylactic antibiotics may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the recurrence of urinary tract infections in children, improving their quality of life.

How similar studies have performed: While the combination of probiotics and antibiotics is a novel approach for preventing recurrent UTIs, similar studies have shown promise in other conditions, indicating potential for success.

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.

Where this trial is running

Chicago, Illinois

• Lurie Children's Hospital — Chicago, Illinois, United States (RECRUITING)

Study contacts

• Principal investigator: Mehreen Arshad — Ann & Robert H Lurie Children's Hospital of Chicago
• Study coordinator: Mehreen Arshad, MD

Conditions: Recurrent Uti