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Probiotic

Probiotic-Antibiotic Combination for Recurrent Urinary Tract Infections

Phase < 1
Recruiting
Led By Mehreen Arshad
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Known history of myasthenia gravis
Individuals under 2 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial compared giving a probiotic & antibiotic to patients with recurrent UTIs to standard of care treatment.

Who is the study for?
This trial is for children and teenagers aged 2-17 who have had at least three urinary tract infections (UTIs) in the past year or two in the last six months. They shouldn't have major bladder issues, any serious genitourinary surgery history, or be on antibiotics when joining.
What is being tested?
The study tests a new approach using the probiotic Saccharomyces Boulardii with Ciprofloxacin antibiotic at the first sign of UTI after enrollment versus standard care. Participants are randomly assigned to one of these treatments.
What are the potential side effects?
Possible side effects include digestive problems from the probiotic and typical antibiotic-related issues like rash, nausea, diarrhea, and potential allergic reactions to Ciprofloxacin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had 3 or more UTIs in the last year or 2 or more in the last 6 months.
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I do not have, or only have mild, backward flow of urine from my bladder.
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I am not taking antibiotics to prevent infection.
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I am between 2 and 17 years old.
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I do not have any abnormalities in my urinary or genital organs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with myasthenia gravis.
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I am under 2 years old.
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I have structural issues with my digestive system.
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I have had surgery on my urinary or digestive system.
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I am currently taking antibiotics to prevent infections.
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I had a urine infection in the last 3 months resistant to ciprofloxacin.
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I am not taking tizanidine or drugs that interact with ciprofloxacin.
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I have a heart condition that affects my heartbeat or I'm on medication that affects my heartbeat.
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I have a condition where my bladder doesn't empty properly due to nerve issues.
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I have severe backward flow of urine from my bladder to kidneys.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction in UTI episodes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Probiotic with or without antibioticExperimental Treatment1 Intervention
All patients will receive probiotics for this, only those with a UTI will get ciprofloxacin.
Group II: ControlActive Control1 Intervention
Patients will get standard of care treatment.

Find a Location

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
267 Previous Clinical Trials
5,181,654 Total Patients Enrolled
Mehreen ArshadPrincipal InvestigatorLurie Children's Hospital
~1 spots leftby Dec 2024
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