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

Last updated: January 14, 2025
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Overall Status: Active - Recruiting

Phase

1

Condition

Urinary Tract Infections

Treatment

Saccharomyces Boulardii 250 MG [Florastor]

Clinical Study ID

NCT06149676
IRB 2022-4941
  • Ages 2-17
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • A history of 3 or more UTI episodes in the past 12 months, or 2 or more episodes inthe past 6 months

  • no evidence of vesicoureteral reflux or only low-grade (grade 1-2) vesicoureteralreflux

  • no other genitourinary anatomical abnormality

  • not receiving prophylactic antibiotics at the time of enrollment

  • Ages 2-17 years.

Exclusion

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 inthe last 3 months

  • history of an allergic reaction to ciprofloxacin or other quinolones, or a historyof severe adverse reactions

  • As stated on the package insert for Ciprofloxacin, individuals with a known historyof myasthenia gravis should avoid taking Ciprofloxacin and therefore will beexcluded from this study.

  • Based on the black box warning for Ciprofloxacin, individuals taking tizanidine asconcomitant administration, or those taking other drugs known to interact withciprofloxacin will be excluded from the study.

  • individuals with known QT prolongation, hypokalemia, or on other drugs that prolongthe QT interval should also avoid taking Ciprofloxacin and will be excluded fromthis study.

  • Individuals under 2 years old. In the BFIT clinic, because they do bladder, bowelmovement, and constipation management, it is harder to manage if the patient is notpotty trained. Therefore, we are excluding participants under 2 years of age.

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: Saccharomyces Boulardii 250 MG [Florastor]
Phase: 1
Study Start date:
February 02, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Lurie Children's Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

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