Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients

Study Overview
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Brief Summary
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The proposed study is a randomized, placebo-controlled clinical trial to test the efficacy of an oral Lactobacillus product dissolved in sterile saline and instilled into the urinary bladder in an attempt to colonize the urinary bladder as well as prevent UTIs.

Detailed Description
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Patients who use a chronic indwelling urinary catheter to drain their bladder will be randomized to receive intravesical instillations of a Lactobacillus solution or sterile saline at the time of a scheduled monthly catheter exchange. Bacterial colonization and frequency of urinary tract infections will be compared between the two groups. The Lactobacillus solution will be derived from the combination of Lactobacillus rhamnosus (GR-1®) and reuteri (RC-14®) species, which is offered as an over the counter probiotic capsule sold under the brand name of Femdophilus and manufactured by CHR-Hansen of Denmark (phone: +45 45747474; email: info@chr-hansen.com). The contents of the capsules will be dissolved in 50 mL of normal saline at room temperature within one hour prior to administration and left indwelling in the patient's urinary bladder for 30 minutes.

Official Title
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A Randomized Double Blinded Study of Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Biological: Femdophilus probiotic
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Chronic indwelling urethral catheter or supra-pubic tube for >6 months Prior symptomatic UTI while catheter in place Exclusion Criteria: Immunosuppressed (HIV, transplant immunosuppression, uncontrolled diabetes) Active infection (may be considered after treatment of active infection) Prior urosepsis requiring ICU admission Significant gross hematuria resulting from catheter exchanges Supravesical urinary diversion Upper urinary tract anatomical abnormality Obstructing urolithiasis Ongoing antibiotic therapy for non-urological infection Indwelling nephrostomy tube or ureteral stent Radiation cystitis Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br> | Biological: Femdophilus probiotic<br>* Lactobacillus rhamnosus (GR-1®) and reuteri (RC-14®) species, which is offered as an over the counter probiotic capsule sold under the brand name of Femdophilus dissolved in 50 mL normal saline at room temperature.<br>|
| Placebo Comparator: Placebo<br> | Other: Normal Saline<br>* 50 mL normal saline at room temperature<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder colonization with Lactobacillus | Percent of patients with urine cultures positive for lactobacilli species after 6 months. | 6 months |