RecruitingEarly Phase 1NCT06149676
A Novel Probiotic-antibiotic Combination to Prevent Recurrent Urinary Tract Infections
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Enrollment
35 participants
Start Date
Feb 2, 2022
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 2 YearsMax Age: 17 Years
Inclusion Criteria5
- 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 Criteria11
- 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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Interventions
DRUGSaccharomyces 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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06149676