Urinary Tract Infections
Conditions
Brief summary
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
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.
Interventions
BIOLOGICALFemdophilus probiotic
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.
OTHERNormal Saline
50 mL normal saline at room temperature
Sponsors
Lahey Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. ≥ 18 years of age 2. Chronic indwelling urethral catheter or supra-pubic tube for \>6 months 3. Prior symptomatic UTI while catheter in place
Exclusion criteria
1. Immunosuppressed (HIV, transplant immunosuppression, uncontrolled diabetes) 2. Active infection (may be considered after treatment of active infection) 3. Prior urosepsis requiring ICU admission 4. Significant gross hematuria resulting from catheter exchanges 5. Supravesical urinary diversion 6. Upper urinary tract anatomical abnormality 7. Obstructing urolithiasis 8. Ongoing antibiotic therapy for non-urological infection 9. Indwelling nephrostomy tube or ureteral stent 10. Radiation cystitis 11. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bladder colonization with Lactobacillus | 6 months | Percent of patients with urine cultures positive for lactobacilli species after 6 months. |
Outcome results
None listed