Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord Injury
Primary Purpose
Spinal Cord Injury, Urinary Tract Infections
Status
Terminated
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Probiotic Lactobacillus GR-1 and RC-14
Sponsored by
About this trial
This is an interventional prevention trial for Spinal Cord Injury focused on measuring spinal cord injury, urinary tract infection, probiotics, Lactobacilli
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
Sites / Locations
- St. Joseph's Health Care
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14
Outcomes
Primary Outcome Measures
Increase time to next UTI
Secondary Outcome Measures
Numbers of infections of any type occurring during probiotic treatment
Full Information
NCT ID
NCT00594594
First Posted
January 4, 2008
Last Updated
July 6, 2009
Sponsor
Lawson Health Research Institute
Collaborators
Ontario Neurotrauma Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00594594
Brief Title
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
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit enough patients to continue on with the study.
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Ontario Neurotrauma Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Urinary Tract Infections
Keywords
spinal cord injury, urinary tract infection, probiotics, Lactobacilli
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14
Intervention Type
Other
Intervention Name(s)
Probiotic Lactobacillus GR-1 and RC-14
Intervention Description
Two capsules of Lactobacillus GR-1 and RC-14 daily for 12 months
Primary Outcome Measure Information:
Title
Increase time to next UTI
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Numbers of infections of any type occurring during probiotic treatment
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J Potter, MD FRCPC
Organizational Affiliation
St. Joseph's Health Care Centre, Parkwood Hospital, Lawson Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gregor Reid, PhD, MBA
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Keith Hayes, PhD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kingsley C Anukam, PhD
Organizational Affiliation
Lawson Health Research Institute, kanukam@uwo.ca
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
17324320
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.
Results Reference
background
Learn more about this trial
Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord Injury
We'll reach out to this number within 24 hrs