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Probiotic
Probiotics for Urinary Tract Infection in Neurogenic Bladder
Phase 1 & 2
Waitlist Available
Led By Sumit Dave
Research Sponsored by London Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 and 6 months
Awards & highlights
Study Summary
This trial will test whether probiotics are safe and can reduce the number of urinary tract infections and the amount of renal scarring in children with neurogenic bladder conditions who are using clean intermittent catheterization.
Eligible Conditions
- Urinary Tract Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Side effects
Secondary outcome measures
Bladder storage function
Changes in metabolomic profiles of urine
Changes in pro-inflammatory cytokines
+2 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: probiotics plus antibioticActive Control2 Interventions
This group will be on a dose of probiotics (2 capsules; 5 billion total organisms of L. rhamnosus GR-1 and L. reuteri RC-14 per capsule) plus a antibiotic (Septra)
Group II: AntibioticActive Control1 Intervention
This group will be prescribed a dose of antibiotics (Septra 2mg/kg)
Group III: Probiotic plus placeboPlacebo Group2 Interventions
Receive probiotic plus an antibiotic placebo
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Who is running the clinical trial?
London Health Sciences CentreLead Sponsor
143 Previous Clinical Trials
49,926 Total Patients Enrolled
Canadian Urological AssociationIndustry Sponsor
7 Previous Clinical Trials
581 Total Patients Enrolled
Sumit DavePrincipal InvestigatorLondon Health Sciences Centre
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to Septra.You have had multiple urinary tract infections in the past year.You have been taking medication to prevent infection for at least one month.You are currently using a catheter to help with a bladder condition caused by a nerve problem.Participants must be between 6 and 20 years old.You have been taking medicine to prevent illness for at least one month.You use a specific method to manage your bladder condition.You have had multiple urinary tract infections in the past year.Participants must be between 6 and 20 years old.
Research Study Groups:
This trial has the following groups:- Group 1: probiotics plus antibiotic
- Group 2: Antibiotic
- Group 3: Probiotic plus placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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