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.
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 of chronic inflammation leading to persistence of white blood cells (WBC) in the urine confounds the utility of WBC count, pyuria, and leukocyte esterase as biomarkers for UTI; nitrites in urine indicate the presence of only specific (but not all) organisms, many of which are present to a greater extent in the urine of people with SCI; and people with SCI have a high prevalence of asymptomatic bacteriuria. These physiologic changes render the gold standard diagnostic tests less useful for identifying UTI in persons with SCI. SA1. Estimate healthy, asymptomatic state variability of urine NGAL (uNGAL), white blood cells (uWBC), nitrite, cultivable bacteria, and the urinary microbiome. SA2. Estimate the effect of intravesical LGG dose on urinary symptoms (primary outcome), uNGAL, uWBC, nitrites, cultivable bacteria, and the urine microbiome (secondary outcomes).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
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.
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States
RECRUITINGUrinary 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)
Time frame: (SA 1) day of urine collection
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)
Time frame: (SA 1) day 1 post urine collection
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)
Time frame: (SA 1) day 2 post urine collection
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)
Time frame: (SA 1) day 3 post urine collection
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
Time frame: (SA 2) Weekly up to 29 months
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)
Time frame: (SA 2) day 1 of intervention (low or high dose)
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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
Time frame: (SA 2) day 2 of intervention (low or high dose)
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
Time frame: (SA 2) day 3 of intervention (low or high dose)
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
Time frame: (SA 2) day 4 of intervention (low or high dose)
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
Time frame: (SA 2) day 5 of intervention (high dose 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)
Time frame: (SA 2) 24-48 hours after intervention completion
Change in Urine white blood cell count
urinalysis. (local urine collection participants only)
Time frame: (SA 1) day 1 post urine collection
Change in Urine white blood cell count
urinalysis. (local urine collection participants only)
Time frame: (SA 1) day 14 post urine collection
Change in Urine white blood cell count
urinalysis. (local urine collection participants only)
Time frame: (SA 2) day 1 of intervention
Change in Urine white blood cell count
urinalysis. (local urine collection participants only)
Time frame: (SA 2) 24-48 hours after intervention completion
Change in Urine Nitrite
urinalysis. (local urine collection participants only)
Time frame: (SA 1) day 1 post urine collection
Change in Urine Nitrite
urinalysis. (local urine collection participants only)
Time frame: (SA 1) day 14 post urine collection
Change in Urine Nitrite
urinalysis. (local urine collection participants only)
Time frame: (SA 2) day 1 of intervention
Change in Urine Nitrite
urinalysis. (local urine collection participants only)
Time frame: (SA 2) 24-48 hours after intervention completion
Change in Urine NGAL
Urine NGAL. (local urine collection participants only)
Time frame: (SA 1) day 1 post urine collection
Change in Urine NGAL
Urine NGAL. (local urine collection participants only)
Time frame: (SA 1) day 14 post urine collection
Change in Urine NGAL
Urine NGAL. (local urine collection participants only)
Time frame: (SA 2) day 1 of intervention
Change in Urine NGAL
Urine NGAL. (local urine collection participants only)
Time frame: (SA 2) 24-48 hours after intervention completion
Change in Cultivable Bacteria
urine culture. (local urine collection participants only)
Time frame: (SA 1) day 1 post urine collection
Change in Cultivable Bacteria
urine culture. (local urine collection participants only)
Time frame: (SA 1) day 14 post urine collection
Change in Cultivable Bacteria
urine culture. (local urine collection participants only)
Time frame: (SA 2) day 1 of intervention
Change in Cultivable Bacteria
urine culture. (local urine collection participants only)
Time frame: (SA 2) 24-48 hours after intervention completion
Change in Urine microbiome composition and function
Next generation sequencing for microbiome composition. (local urine collection participants only)
Time frame: (SA 1) day 1 post urine collection
Change in Urine microbiome composition and function
Next generation sequencing for microbiome composition. (local urine collection participants only)
Time frame: (SA 1) day 14 post urine collection
Change in Urine microbiome composition and function
Next generation sequencing for microbiome composition. (local urine collection participants only)
Time frame: (SA 2) day 1 of intervention
Change in Urine microbiome composition and function
Next generation sequencing for microbiome composition. (local urine collection participants only)
Time frame: (SA 2) 24-48 hours after intervention completion
NINDS Medical History CDE:
A brief medical history using body system categories
Time frame: Baseline
Medical History Form
Medical history of participant
Time frame: Baseline
International SCI Lower Urinary Tract Function Basic Data Set
A tool to describe urinary tract impairment, awareness of need to empty the bladder, main bladder emptying method, medications used for bladder management, surgeries, and change in urinary symptoms in the past year.
Time frame: Baseline
NINDS Prior and Concomitant Medications CDE
Contains whether or not the participant is taking a medication during the study protocol, name of medication, reason for medication, medication dose, frequency, start and end dates, and free text
Time frame: Baseline