RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-02

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06149676

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Mehreen Arshad, MD

CONTACT

3122274080

marshad@luriechildrens.org

Principal Investigator

Mehreen Arshad

PRINCIPAL_INVESTIGATOR

Lurie Children's Hospital

Study Locations (Sites)

Lurie Children's Hospital

Chicago, Illinois, 60611

United States

Collaborators and Investigators

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

Mehreen Arshad, PRINCIPAL_INVESTIGATOR, Lurie Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-02

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-02-02

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Recurrent Uti