Actively Recruiting
A Novel Probiotic-antibiotic Combination to Prevent Recurrent Urinary Tract Infections
Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2025-01-15
35
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate a new approach for preventing recurrent urinary tract infections (UTIs) in children and adolescents aged 2 to 17 years. It compares the use of a probiotic called Saccharomyces Boulardii combined with an antibiotic, ciprofloxacin, given when a UTI occurs, against standard care treatments. The study focuses on patients with a history of multiple UTIs and certain urinary tract conditions, aiming to reduce the number of UTI episodes over six months. Participants will receive the probiotic Saccharomyces Boulardii once daily for six months regardless of symptoms. At enrollment, all participants will be provided with ciprofloxacin. Those who have UTI symptoms or a positive urine culture at the start will take ciprofloxacin every 12 hours for 14 days. Those without symptoms will take the antibiotic only if a UTI occurs later. All participants will continue to receive standard clinical care, including management of bowel and bladder function and other non-antibiotic treatments as determined by their healthcare providers. Throughout the study, participants will be monitored for UTI episodes, with the primary outcome being the reduction in UTI episodes over six months. Researchers will track adherence to the probiotic and antibiotic regimens and standard care practices. Safety and tolerability will be observed, and participants’ health will be assessed through clinical visits and urine cultures as needed. The study duration and follow-up ensure careful observation of the treatments’ effects and participants’ well-being.
CONDITIONS
Brief Title
A Novel Probiotic-antibiotic Combination to Prevent Recurrent Urinary Tract Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of 3 or more urinary tract infections 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 abnormalities
- Not receiving prophylactic antibiotics at the time of enrollment
- Ages 2 to 17 years
You will not qualify if you...
- High-grade (grade 3-5) vesicoureteral reflux
- Neurogenic bladder
- Anatomical abnormalities of the gastrointestinal tract
- Any history of urologic or gastrointestinal surgery
- Currently on prophylactic antibiotics
- Urine culture positive for pathogens not susceptible to ciprofloxacin in the last 3 months
- History of allergic or severe adverse reactions to ciprofloxacin or quinolones
- Known history of myasthenia gravis
- Taking tizanidine or other drugs that interact with ciprofloxacin
- Known QT prolongation, hypokalemia, or use of drugs that prolong QT interval
- Under 2 years old due to bladder and bowel management challenges
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take the probiotic Saccharomyces boulardii once daily for 6 months. Those with symptoms or a positive urine culture at enrollment take the antibiotic ciprofloxacin every 12 hours for 14 days. Participants without symptoms take ciprofloxacin only if a UTI occurs during the study. Participants continue their standard clinical care for recurrent UTI management throughout the study.
Visits as needed for standard clinical care and UTI symptom management
Trial Site Locations
Total: 1 location
1
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
M
Mehreen Arshad, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Frequently Asked Questions
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