Clinical trial NCT00594594: Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord Injury
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Spinal Cord Injury
Urinary Tract Infections
Keywords: spinal cord injury
urinary tract infection
probiotics
Lactobacilli
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Ontario Neurotrauma Foundation
First posted: 2008-01-15
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Increase time to next UTI
timeFrame: 12 months
Secondary outcomes:
measure: Numbers of infections of any type occurring during probiotic treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: St. Joseph's Health Care Centre, Parkwood Hospital, Lawson Health Research Institute
name: Patrick J Potter, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Gregor Reid, PhD, MBA
role: STUDY_DIRECTOR
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Keith Hayes, PhD
role: STUDY_CHAIR
affiliation: Lawson Health Research Institute, kanukam@uwo.ca
name: Kingsley C Anukam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayes KC, Bassett-Spiers K, Das R, Ethans KD, Kagan C, Kramer JL, Linsenmeyer T, Moore KN, Razvi H, Reid G, Walter JS, Wilson JW. Research priorities for urological care following spinal cord injury: recommendations of an expert panel. Can J Urol. 2007 Feb;14(1):3416-23.