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

This study has been terminated.
(Unable to recruit enough patients to continue on with the study.)
Sponsor:
Collaborator:
Ontario Neurotrauma Foundation
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00594594
First received: January 4, 2008
Last updated: July 6, 2009
Last verified: July 2009
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Increase time to next UTI [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Numbers of infections of any type occurring during probiotic treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: September 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594594

Locations
Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Ontario Neurotrauma Foundation
Investigators
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

Publications:

Responsible Party: Dr. Gregor Reid, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00594594     History of Changes
Other Study ID Numbers: R-06-213, HSREB 12845
Study First Received: January 4, 2008
Last Updated: July 6, 2009
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
spinal cord injury
urinary tract infection
probiotics
Lactobacilli

Additional relevant MeSH terms:
Spinal Cord Injuries
Urinary Tract Infections
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Trauma, Nervous System
Wounds and Injuries
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013