Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official 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

Conditions
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Spinal Cord Injury, Urinary Tract Infections

Intervention / Treatment
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* Other: Probiotic Lactobacillus GR-1 and RC-14


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 | Other: Probiotic Lactobacillus GR-1 and RC-14<br>* Two capsules of Lactobacillus GR-1 and RC-14 daily for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase time to next UTI |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of infections of any type occurring during probiotic treatment |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injury, urinary tract infection, probiotics, Lactobacilli