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

Phase 1TerminatedNCT00594594

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's2 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Spinal Cord Injury Urinary Tract Infections

Interventions

Probiotic Lactobacillus GR-1 and RC-14OTHER

Two capsules of Lactobacillus GR-1 and RC-14 daily for 12 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

St. Joseph's Health Care

London, Ontario, Canada

Outcomes

Primary Outcomes

Increase time to next UTI

Time frame: 12 months

Secondary Outcomes

Numbers of infections of any type occurring during probiotic treatment

Time frame: 12 months

Data from ClinicalTrials.gov

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