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Probiotic

Probiotic-Antibiotic Combination for Recurrent Urinary Tract Infections

Q: Is it possible to participate in this investigation?

Admission into this medical research requires that the subject is suffering from a urinary tract infection and aged between 2 and 17. A maximum of 35 participants will be accepted.

Q: Is the age limit for this trial restricted to individuals under 55 years old?

To participate in this study, patients must be aged 2 to 17. According to the database on clinicaltrials.gov, there are 179 studies open for minors and 940 trials recruiting adults over 65 years old.

Q: Is enrollment for this scientific experiment open at the moment?

Yes, according to clinicaltrials.gov this research is presently recruiting individuals into the study which was initially posted on February 2nd 2022 and most recently updated November 21st 2023.

Q: How many participants are enrolled in this research study?

Affirmative, clinicaltrials.gov states that this trial is in progress and looking for participants. The study was initially announced on February 2nd 2022 and last modified on November 21st 2023. 35 people are required from a single location.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have had 3 or more UTIs in the last year or 2 or more in the last 6 months.

Select...

I do not have, or only have mild, backward flow of urine from my bladder.

Select...

I am not taking antibiotics to prevent infection.

Select...

I am between 2 and 17 years old.

Select...

I do not have any abnormalities in my urinary or genital organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reduction in UTI episodes

Side effects data

From 2012 Phase 4 trial • 35 Patients • NCT01749605

Rash

100%

80%

60%

40%

20%

Study treatment Arm

Nitrofurantoin 100 mg

Ciprofloxacin 250 mg

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor

258 Previous Clinical Trials

5,189,095 Total Patients Enrolled

Mehreen ArshadPrincipal InvestigatorLurie Children's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to participate in this investigation?

"Admission into this medical research requires that the subject is suffering from a urinary tract infection and aged between 2 and 17. A maximum of 35 participants will be accepted."

Answered by AI

Is the age limit for this trial restricted to individuals under 55 years old?

"To participate in this study, patients must be aged 2 to 17. According to the database on clinicaltrials.gov, there are 179 studies open for minors and 940 trials recruiting adults over 65 years old."

Answered by AI

Is enrollment for this scientific experiment open at the moment?

"Yes, according to clinicaltrials.gov this research is presently recruiting individuals into the study which was initially posted on February 2nd 2022 and most recently updated November 21st 2023."

Answered by AI

How many participants are enrolled in this research study?

"Affirmative, clinicaltrials.gov states that this trial is in progress and looking for participants. The study was initially announced on February 2nd 2022 and last modified on November 21st 2023. 35 people are required from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Mehreen Arshad 2022. "A Novel Probiotic-antibiotic Combination to Prevent Recurrent Urinary Tract Infections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06149676.