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

Phase 1

Terminated

• Conditions: Spinal Cord Injury; Urinary Tract Infections
• Interventions: Other: Probiotic Lactobacillus GR-1 and RC-14

• Registration Number: NCT00594594
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-15
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-06
• Last Update Posted: 2009-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Probiotic Lactobacillus GR-1 and RC-14	Probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14

Primary Outcome Measures

Name	Time	Method
Increase time to next UTI	12 months

Secondary Outcome Measures

Name	Time	Method
Numbers of infections of any type occurring during probiotic treatment	12 months

Trial Locations

Locations (1)

St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada