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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Uti
• Intervention / Treatment: Drug: Saccharomyces Boulardii 250 MG [Florastor]

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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Mehreen Arshad, MD; Phone Number: 3122274080; Email: marshad@luriechildrens.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Lurie Children's Hospital
      • Contact: Mehreen Arshad; Phone Number: 312-227-4080; Email: marshad@luriechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic with or without antibiotic; All patients will receive probiotics for this, only those with a UTI will get ciprofloxacin.	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; Other Names: ciprofloxacin
No Intervention: Control; Patients will get standard of care treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in UTI episodes	We will look for a reduction the number of UTI episodes before and after the intervention.	6 months

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: Mehreen Arshad, Lurie Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Infections; Recurrence; Urinary Tract Infections; Anti-Bacterial Agents; Anti-Infective Agents; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Topoisomerase Inhibitors; Topoisomerase II Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: IRB 2022-4941

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No