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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00594594 |
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Date of registration:
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04/01/2008 |
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Primary sponsor: |
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Public title:
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Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord Injury
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Scientific title:
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A Multi-Centered, Randomized, Double-Blind, Placebo-Controlled Trial for Efficacy in the Use of Adjuntive Probiotic Therapy in Reducing Urinary Tract Infections in Those Individual With Spinal Cord Injury |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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2 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00594594 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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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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Gregor Reid, PhD, MBA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lawson Health Research Institute |
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Name:
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Keith Hayes, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lawson Health Research Institute |
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Name:
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Kingsley C Anukam, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lawson Health Research Institute, kanukam@uwo.ca |
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Name:
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Patrick J Potter, MD FRCPC |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Joseph's Health Care Centre, Parkwood Hospital, Lawson Health Research Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Spinal cord injury
- UTI
- > 18years
- Male and females
- Prescribed antibiotics
Exclusion Criteria:
- Patients who are participating in another clinical study involving pharmaceutical
products.
- Patients who are participating in other urology clinical study.
- Patients taking yogurt containing probiotic lactobacilli during the period of the
study.
- Females who are pregnant and/or planning to get pregnant during the study period
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Spinal Cord Injury
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Urinary Tract Infections
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Intervention(s)
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Other: Probiotic Lactobacillus GR-1 and RC-14
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Primary Outcome(s)
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Increase time to next UTI
[Time Frame: 12 months]
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Secondary Outcome(s)
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Numbers of infections of any type occurring during probiotic treatment
[Time Frame: 12 months]
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Secondary ID(s)
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HSREB 12845
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R-06-213
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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