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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00594594
Recruitment Status : Terminated (Unable to recruit enough patients to continue on with the study.)
First Posted : January 15, 2008
Last Update Posted : July 7, 2009
Ontario Neurotrauma Foundation
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Urinary Tract Infections Other: Probiotic Lactobacillus GR-1 and RC-14 Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : September 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Increase time to next UTI [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Numbers of infections of any type occurring during probiotic treatment [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00594594

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

Responsible Party: Dr. Gregor Reid, Lawson Health Research Institute Identifier: NCT00594594     History of Changes
Other Study ID Numbers: R-06-213
HSREB 12845
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: July 7, 2009
Last Verified: July 2009

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

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