Actively Recruiting

Early Phase 1
Age: 2Years - 17Years
All Genders
Healthy Volunteers
ID06149676

A Study of Probiotic Saccharomyces Boulardii and Antibiotic Ciprofloxacin to Prevent Recurrent Urinary Tract Infections in Children

Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2025-01-15

35

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying children aged 2 to 17 years who have recurrent urinary tract infections (UTIs). The trial evaluates a new combination of a probiotic called Saccharomyces Boulardii and the antibiotic ciprofloxacin to prevent repeated UTIs. This early-phase study includes participants with specific urinary tract conditions and excludes those with more severe urinary abnormalities or certain medication interactions to ensure safety. Participants receive 250 mg of the probiotic Saccharomyces Boulardii daily for six months, regardless of symptoms. At enrollment, they are also given ciprofloxacin at a dose of 20 mg/kg. If they have UTI symptoms or a positive urine culture at enrollment, they take ciprofloxacin every 12 hours for 14 days. If they do not have symptoms, ciprofloxacin is only taken at home if a UTI occurs for the first time after enrollment. Standard care for managing recurrent UTIs, including bowel and bladder management, continues throughout the study. During the study, researchers monitor participants for reduction in UTI episodes over six months. Participants receive usual clinical care, and any UTIs caused by bacteria sensitive to ciprofloxacin are treated accordingly. The study tracks safety and effectiveness by assessing UTI recurrence rates and managing any adverse effects. The total participation period includes probiotic treatment and follow-up to evaluate outcomes over half a year.

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 abnormalities
  • Not receiving prophylactic antibiotics at enrollment
  • Ages 2 to 17 years
Not Eligible

You will not qualify if you...

  • High-grade (grade 3-5) vesicoureteral reflux
  • Neurogenic bladder
  • Anatomical abnormalities of the gastrointestinal tract
  • History of urologic or gastrointestinal surgery
  • Currently on prophylactic antibiotics
  • Positive urine culture for pathogens resistant to ciprofloxacin in the last 3 months
  • Allergic reaction or severe adverse reaction to ciprofloxacin or other quinolones
  • Known history of myasthenia gravis
  • Taking tizanidine or other drugs that interact with ciprofloxacin
  • Known QT prolongation, hypokalemia, or taking drugs that prolong QT interval
  • Younger than 2 years old

AI-Screening

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Trial Site Locations

Total: 1 location

1

Lurie Children's Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

M

Mehreen Arshad, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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