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

L

Lawson Health Research Institute

Status and phase

Terminated
Phase 1

Conditions

Urinary Tract Infections
Spinal Cord Injury

Treatments

Other: Probiotic Lactobacillus GR-1 and RC-14

Study type

Interventional

Funder types

Other

Identifiers

NCT00594594
R-06-213
HSREB 12845

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

2 participants in 1 patient group

1
Experimental group
Description:
Probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14
Treatment:
Other: Probiotic Lactobacillus GR-1 and RC-14

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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