Clinical trial
Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters
Name
STUDY00001782
Description
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.
Trial arms
Trial start
2020-01-10
Estimated PCD
2024-12-01
Trial end
2025-09-01
Status
Recruiting
Phase
Early phase I
Treatment
Culturelle 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.
Arms:
High dosage, Low Dosage
Other names:
Lactobacillus Rhamnosus GG
Size
182
Primary endpoint
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
(SA 1) day of urine collection
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
(SA 1) day 1 post urine collection
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
(SA 1) day 2 post urine collection
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
(SA 1) day 3 post urine collection
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
(SA 2) Weekly up to 29 months
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
(SA 2) day 1 of intervention (low or high dose)
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
(SA 2) day 2 of intervention (low or high dose)
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
(SA 2) day 3 of intervention (low or high dose)
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
(SA 2) day 4 of intervention (low or high dose)
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
(SA 2) day 5 of intervention (high dose only)
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
(SA 2) 24-48 hours after intervention completion
Change in Urine white blood cell count
(SA 1) day 1 post urine collection
Change in Urine white blood cell count
(SA 1) day 14 post urine collection
Change in Urine white blood cell count
(SA 2) day 1 of intervention
Change in Urine white blood cell count
(SA 2) 24-48 hours after intervention completion
Change in Urine Nitrite
(SA 1) day 1 post urine collection
Change in Urine Nitrite
(SA 1) day 14 post urine collection
Change in Urine Nitrite
(SA 2) day 1 of intervention
Change in Urine Nitrite
(SA 2) 24-48 hours after intervention completion
Change in Urine NGAL
(SA 1) day 1 post urine collection
Change in Urine NGAL
(SA 1) day 14 post urine collection
Change in Urine NGAL
(SA 2) day 1 of intervention
Change in Urine NGAL
(SA 2) 24-48 hours after intervention completion
Change in Cultivable Bacteria
(SA 1) day 1 post urine collection
Change in Cultivable Bacteria
(SA 1) day 14 post urine collection
Change in Cultivable Bacteria
(SA 2) day 1 of intervention
Change in Cultivable Bacteria
(SA 2) 24-48 hours after intervention completion
Change in Urine microbiome composition and function
(SA 1) day 1 post urine collection
Change in Urine microbiome composition and function
(SA 1) day 14 post urine collection
Change in Urine microbiome composition and function
(SA 2) day 1 of intervention
Change in Urine microbiome composition and function
(SA 2) 24-48 hours after intervention completion
NINDS Medical History CDE:
Baseline
Medical History Form
Baseline
International SCI Lower Urinary Tract Function Basic Data Set
Baseline
NINDS Prior and Concomitant Medications CDE
Baseline
Eligibility criteria
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 could be confounded.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Design: Prospective, randomized pilot intervention clinical trial. Target Enrollment: 182 subjects with NLUTD at least 6 months and who use IDC for bladder management. Setting: National sample (N=114 intervention only, no urine collection) and local Washington, DC metropolitan area (N=68 intervention + urine collection).\n\nControls: This is a 2-arm dose-finding pilot clinical trial, as such there is no control group', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 182, 'type': 'ESTIMATED'}}
Updated at
2024-05-03
1 organization
Organization
MedStar Health Research Institute