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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 September 2021 |
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Main ID: |
NCT02044965 |
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Date of registration:
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17/01/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Can Probiotics be Used in the Prevention of Recurrent UTI in Paediatric Neurogenic Bladder
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Scientific title:
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A Clinical Trial to Determine the Extent to Which Probiotic Therapy Reduces Side Effects of Antibiotic Prophylaxis in Pediatric Neurogenic Bladder Patients With a History of Recurrent Urinary Tract Infections |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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36 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02044965 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Sumit Dave |
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Address:
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Telephone:
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519-685-8439 |
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Email:
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sumit.dave@lhsc.on.ca |
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Affiliation:
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Name:
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Lee-Anne Fochesato |
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Address:
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Telephone:
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5196858500 |
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Email:
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leeanne.fochesato@lhsc.on.ca |
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Affiliation:
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Name:
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Sumit Dave |
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Address:
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Telephone:
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Email:
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Affiliation:
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London Health Sciences Centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- - Patients will have had a history of recurrent urinary tract infections over the past
12 months.
- Patients will have been receiving chemoprophylaxis for at least one month.
- Patients who are using clean intermittent catheterization to manage a neurogenic
bladder condition.
- PATIENTS WILL BE BETWEEN THE AGES OF 6-20.
Exclusion Criteria:
- Patient has a known allergy to Septra
- Patients pregnant or nursing will be excluded.
Age minimum:
12 Years
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Urinary Tract Infection
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Intervention(s)
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Drug: Probiotic
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Other: Antibiotic
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Primary Outcome(s)
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Side effects
[Time Frame: Once a week for the duration of the study. The length of the study will be 6 months from the first baseline visit after the patient has been enrolled in the study and the first dispense of the study drug has been completed.]
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Secondary Outcome(s)
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Time to first urinary tract infection
[Time Frame: Over 6 months follow up]
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Changes in pro-inflammatory cytokines
[Time Frame: At baseline, 3 and 6 months]
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Changes in metabolomic profiles of urine
[Time Frame: Baseline, 3 and 6 months]
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Mean number of recurrent urinary tract infection episodes
[Time Frame: Over the 6 months follow up]
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Bladder storage function
[Time Frame: Baseline, 6 months]
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Secondary ID(s)
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LHSC - AP 1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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