NCT06149676CompletedPhase 1
A Novel Probiotic-antibiotic Combination to Prevent Recurrent Urinary Tract Infections
Ann & Robert H Lurie Children's Hospital of Chicago1 site in 1 country35 target enrollmentStarted: February 2, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Reduction in UTI episodes
Study Overview
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.
Detailed Description
- At the time of consent, participants will be given 20 mg/kg of the antibiotic, ciprofloxacin. If the participant has symptoms of a UTI or have a positive urine culture at enrollment, they will take the antibiotic every 12 hours for 14 days. If the participant does not have symptoms of a UTI at enrollment, the antibiotic will be taken only if needed at home upon the first occurrence of a UTI.
- At the time of consent, participants will also be given 250 mg of the probiotic, S.
boulardii, taken once daily for 6 months, irrespective of symptoms.
- Throughout the study, participants will receive their standard clinical care for recurrent UTI treatment, which includes bowel and bladder dysfunction management and other prescribed non-antibiotic interventions at the managing provider's clinical discretion.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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.
Exclusion Criteria
- •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.
Arms & Interventions
Probiotic with or without antibiotic
Experimental
All patients will receive probiotics for this, only those with a UTI will get ciprofloxacin.
Intervention: Saccharomyces Boulardii 250 MG [Florastor] (Drug)
Control
No Intervention
Patients will get standard of care treatment.
Outcomes
Primary Outcomes
Reduction in UTI episodes
Time Frame: 6 months
We will look for a reduction the number of UTI episodes before and after the intervention.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mehreen Arshad
Assistant Professor
Ann & Robert H Lurie Children's Hospital of Chicago
Study Sites (1)
Loading locations...
Similar Trials
Terminated
Phase 1
Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord InjuryUrinary Tract InfectionsSpinal Cord InjuryNCT00594594Lawson Health Research Institute2
Completed
Not Applicable
The Efficacy of a Probiotic Product on Acute Upper Respiratory Tract Infections (Common Cold) in Healthy ChildrenAcute Upper Respiratory Tract Infections (Common Cold)NCT02640352Probi AB550
Active, not recruiting
Phase 3
Probiotic Saccharomyces boulardii for the prevention of antibiotic-associated diarrhoea. Randomised, double-blind, placebo-controlled trialantibiotic-associated diarrhoeaA04.7Enterocolitis due to Clostridium difficileDRKS00000084Bernhard-Nocht-Institut für Tropenmedizin477
Active, not recruiting
Not Applicable
Probiotic Saccharomyces boulardii for the prevention of antibiotic-associated diarrhoeaAntibiotic - associated - Diarrhoea (AAD)Clostridium difficile - associated - Diarrhoea (CDAD)MedDRA version: 14.1Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10006835Term: C.difficile diarrhoeaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10055956Term: Antibiotic-associated diarrhoeaSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2009-017374-20-DEBernhard-Nocht-Institute for Tropical Medicine1,520
Terminated
Phase 4
Probiotics and the Prevention of Traveler's DiarrheaTravelers' DiarrheaNCT01005849Lallemand SAS420