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

NCT06149676 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: IRB 2022-4941
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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 enrollment, or they received standard of care treatment.

Conditions

Recurrent Uti

Outcome Measures

Primary Outcomes (1)

• Reduction in UTI episodes

  We will look for a reduction the number of UTI episodes before and after the intervention.

  6 months

Study Arms (2)

Probiotic with or without antibiotic

EXPERIMENTAL

All patients will receive probiotics for this, only those with a UTI will get ciprofloxacin.

Drug: Saccharomyces Boulardii 250 MG [Florastor]

Control

NO INTERVENTION

Patients will get standard of care treatment.

Interventions

Saccharomyces Boulardii 250 MG [Florastor] DRUG

All patients will get the probiotic to be taken daily. If UTI occurs with a sensitive pathogen, we will treat with ciprofloxacin

Also known as: ciprofloxacin

Probiotic with or without antibiotic

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mehreen Arshad

  Lurie Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehreen Arshad, MD

CONTACT

3122274080; marshad@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 29, 2023
• Study Start: February 2, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)