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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

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

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

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