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.
Neurogenic bladder for at least 6 months;
Utilizing indwelling catheterization for bladder management;
Women must be premenopausal and not currently menstruating;
Community dwelling
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;
Parallel
Culturelle 10 Billion CFU Capsule
DrugLGG® (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.
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Click on the lead sponsor to view all of their trials.
Medstar Health Research Institute
Lead sponsor
Children's National Research Institute
Collaborator
