NCT06149676

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

• Recurrent Uti

Interventions

Type	Name	Description
DRUG	Saccharomyces 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

Timeline

• Start date: 2022-02-02
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2023-11-29
• Last updated: 2025-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study