Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters
Medstar Health Research Institute
Summary
The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical Lactobacillus RhamnosusGG (LGG®) dose to be used to reduce urinary symptoms in a future clinical trial.
Description
Urinary tract infection (UTI) is the most common outpatient infection world-wide, and for people with spinal cord injury (SCI) and neurogenic bladder (NB), it is the most common infection, secondary condition, cause for emergency room visits, and infectious cause of hospitalization. Despite its prevalence, attempts to ameliorate UTI among people with SCI are stymied by long-standing diagnostic challenges which arise from evidence gaps around "gold standard" diagnostic tests (urinalysis and urine culture) that have lower sensitivity and specificity for UTI in this population. A high prevalence…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Neurogenic bladder for at least 6 months; * Utilizing indwelling catheterization for bladder management; * Women must be premenopausal and not currently menstruating; * Community dwelling * physical disability Exclusion Criteria: * Use of prophylactic antibiotics; * Instillation of intravesical antimicrobials to prevent UTI; * Psychologic or psychiatric conditions influencing the ability to follow instructions; * Use of oral or IV antibiotics within the past 2 weeks; * Sexual activity within the previous 72 hours; * Participation in another study with which results cou…
Interventions
- DrugCulturelle 10 Billion CFU Capsule
LGG® (Culturelle Probiotic with Lactobacillus RhamnosusGG, shown to produce the largest amount of antibacterial substances against pathogenic bacteria) will be used. For the LGG® instillation, participants will be instructed to mix the contents of 1 LGG capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG mixture into a 60cc syringe and instill via the indwelling catheter (the catheter will not be changed as this would represent 2 interventions). Participants will be instructed the plug their catheter for 1 hour. Participants will receive 2 or 4 LGG capsules (depending on randomization group) and will repeat this process the following day ("Low" dose) or twice daily for a total of four doses ("High" dose) according to randomization group.
Location
- MedStar National Rehabilitation HospitalWashington D.C., District of Columbia