Status:
RECRUITING
A Novel Probiotic-antibiotic Combination to Prevent Recurrent Urinary Tract Infections
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Conditions:
Recurrent Uti
Eligibility:
All Genders
2-17 years
Phase:
EARLY_PHASE1
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 enroll...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06149676
Start Date
February 2 2022
End Date
December 31 2025
Last Update
January 15 2025
Active Locations (1)
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1
Lurie Children's Hospital
Chicago, Illinois, United States, 60611