Study Stopped
The study never started. It was withdrawn from the IRB.
Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients
A Randomized Double Blinded Study of Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2021
Shorter than P25 for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2019
CompletedFirst Posted
Study publicly available on registry
September 4, 2019
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2021
CompletedJuly 8, 2021
July 1, 2021
3 months
August 28, 2019
July 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Bladder colonization with Lactobacillus
Percent of patients with urine cultures positive for lactobacilli species after 6 months.
6 months
Study Arms (2)
Probiotic
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- ≥ 18 years of age
- Chronic indwelling urethral catheter or supra-pubic tube for \>6 months
- Prior symptomatic UTI while catheter in place
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lahey Cliniclead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2019
First Posted
September 4, 2019
Study Start
April 1, 2021
Primary Completion
June 30, 2021
Study Completion
September 15, 2021
Last Updated
July 8, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share