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| Sponsors and Collaborators: |
Lawson Health Research Institute Ontario Neurotrauma Foundation |
|---|---|
| Information provided by: | Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT00594594 |
Purpose
We hypothesize that probiotic Lactobacillus can augment antibiotic treatment of symptomatic urinary tract infection (UTI) in spinal cord injured patients, and also increase the time to the next episode of UTI.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injury Urinary Tract Infections |
Other: Probiotic Lactobacillus GR-1 and RC-14 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 92 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14
|
Other: Probiotic Lactobacillus GR-1 and RC-14
Two capsules of Lactobacillus GR-1 and RC-14 daily for 12 months
|
Subjects will be recruited from the outpatient population and 'alumni' of the Regional SCI Rehabilitation Programs in London (Parkwood Hospital/St Joseph's Health Care) and Hamilton (Hamilton Health Sciences Centre) Ontario.
Community living paraplegic and tetraplegic men and women (18 years and above) who present to their family physician or specialist with symptomatic UTI will be prescribed an antibiotic treatment for up to 14 days (using the drug of choice i.e. which the treating physician deems appropriate) and randomized to also receive by mouth two capsules containing placebo or probiotic Lactobacillus rhamnosus GR-1 and L. reuteri RC-14 daily.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Patrick J Potter, MD FRCPC | 519-685-4080 | patrick.potter@sjhc.london.on.ca |
| Contact: Gregor Reid, PhD, MBA | 519-646-6000 | gregor@uwo.ca |
| Canada, Ontario | |
| Parkwood Hospital | Recruiting |
| London, Ontario, Canada, N6C5J1 | |
| Principal Investigator: Patrick Portter, MD, FRCPC | |
| Sub-Investigator: K Sequeira, MD. FRCPC | |
| Sub-Investigator: Kingsley Anukam, PhD | |
| Sub-Investigator: Keith Hayes, PhD | |
| Principal Investigator: | Patrick J Potter, MD FRCPC | St. Joseph's Health Care Centre, Parkwood Hospital, Lawson Health Research Institute |
| Study Director: | Gregor Reid, PhD, MBA | Lawson Health Research Institute |
| Study Chair: | Keith Hayes, PhD | Lawson Health Research Institute |
| Principal Investigator: | Kingsley C Anukam, PhD | Lawson Health Research Institute, kanukam@uwo.ca |
More Information
| Responsible Party: | L ( Dr. Gregor Reid ) |
| Study ID Numbers: | R-06-213, HSREB 12845 |
| Study First Received: | January 4, 2008 |
| Last Updated: | January 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00594594 |
| Health Authority: | Canada: Health Canada |
|
spinal cord injury urinary tract infection probiotics Lactobacilli |
|
Spinal Cord Injuries Urologic Diseases Spinal Cord Diseases Urinary Tract Infections |
Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
|
Communicable Diseases Nervous System Diseases Infection |
