Status:
WITHDRAWN
Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients
Lead Sponsor:
Lahey Clinic
Conditions:
Urinary Tract Infections
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 att...
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 sc...
Eligibility Criteria
Inclusion
- ≥ 18 years of age
- Chronic indwelling urethral catheter or supra-pubic tube for \>6 months
- Prior symptomatic UTI while catheter in place
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04077749
Start Date
April 1 2021
End Date
September 15 2021
Last Update
July 8 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.