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

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00594594
• Other study ID #: R-06-213
• Secondary ID: HSREB 12845
• Status: Terminated
• Phase: Phase 1
• First received: January 4, 2008
• Last updated: July 6, 2009
• Start date: September 2007
• Est. completion date: May 2009

Study information

• Verified date: July 2009
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Spinal Cord Injuries
• Spinal Cord Injury
• Urinary Tract Infections

Intervention

Other:
• Probiotic Lactobacillus GR-1 and RC-14
Two capsules of Lactobacillus GR-1 and RC-14 daily for 12 months

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Ontario Neurotrauma Foundation

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase time to next UTI		12 months	No
Secondary	Numbers of infections of any type occurring during probiotic treatment		12 months	No