NCT00594594

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

July 7, 2009

Status Verified

July 1, 2009

Enrollment Period

1.7 years

First QC Date

January 4, 2008

Last Update Submit

July 6, 2009

Conditions

Spinal Cord InjuryUrinary Tract Infections

Keywords

spinal cord injuryurinary tract infectionprobioticsLactobacilli

Outcome Measures

Primary Outcomes (1)

  • Increase time to next UTI

    12 months

Secondary Outcomes (1)

  • Numbers of infections of any type occurring during probiotic treatment

    12 months

Study Arms (1)

1

EXPERIMENTAL

Probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14

Other: Probiotic Lactobacillus GR-1 and RC-14

Interventions

Probiotic Lactobacillus GR-1 and RC-14OTHER

Two capsules of Lactobacillus GR-1 and RC-14 daily for 12 months

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spinal cord injury
  • UTI
  • \> 18years
  • Male and females
  • Prescribed antibiotics

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 17324320BACKGROUND

MeSH Terms

Conditions

Spinal Cord InjuriesUrinary Tract Infections

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Patrick J Potter, MD FRCPC

    St. Joseph's Health Care Centre, Parkwood Hospital, Lawson Health Research Institute

    PRINCIPAL INVESTIGATOR

  • Gregor Reid, PhD, MBA

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    STUDY DIRECTOR

  • Keith Hayes, PhD

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    STUDY CHAIR

  • Kingsley C Anukam, PhD

    Lawson Health Research Institute, kanukam@uwo.ca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 15, 2008

Study Start

September 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

July 7, 2009

Record last verified: 2009-07

Locations

CA(1)