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

July 6, 2009 updated by: Lawson Health Research Institute

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • St. Joseph's Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase time to next UTI
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Numbers of infections of any type occurring during probiotic treatment
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

January 4, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 15, 2008

Study Record Updates

Last Update Posted (Estimate)

July 7, 2009

Last Update Submitted That Met QC Criteria

July 6, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-06-213
  • HSREB 12845

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Tract Infections

Clinical Trials on Probiotic Lactobacillus GR-1 and RC-14

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe