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

NCT ID: NCT00594594

Last Updated: 2009-07-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-05-31

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.

Conditions

Spinal Cord Injury; Urinary Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

1

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

Group Type: EXPERIMENTAL

Probiotic Lactobacillus GR-1 and RC-14

Intervention Type: OTHER

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

Interventions

Probiotic Lactobacillus GR-1 and RC-14

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario Neurotrauma Foundation

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Lawson Health Research Institute

Principal Investigators

Patrick J Potter, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

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

Gregor Reid, PhD, MBA

Role: STUDY_DIRECTOR

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

Keith Hayes, PhD

Role: STUDY_CHAIR

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

Kingsley C Anukam, PhD

Role: PRINCIPAL_INVESTIGATOR

Lawson Health Research Institute, kanukam@uwo.ca

Locations

St. Joseph's Health Care

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 17324320 (View on PubMed)

Other Identifiers

HSREB 12845

Identifier Type: -

Identifier Source: secondary_id

R-06-213

Identifier Type: -

Identifier Source: org_study_id