Clinical trial
Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury
Name
STUDY00001124
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
2020-05-20
Estimated PCD
2025-05-01
Trial end
2026-05-01
Status
Recruiting
Phase
Early phase I
Treatment
Culturelle 10 Billion CFU Capsule (2 doses)
For the LGG instillation, participants will be instructed to mix the contents of 1 LGG capsule into saline. After mixing, participants will draw up the liquid LGG mixture into a syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 2 LGG capsules and will repeat this process the following night ("Low" dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (2 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining capsules
Arms:
Low Dosage Group
Other names:
Lactobacillus RhamnosusGG
Culturelle 10 Billion CFU Capsule (4 doses)
For the LGG instillation, participants will be instructed to mix the contents of 1 LGG capsule into saline. After mixing, participants will draw up the liquid LGG mixture into a syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 4 LGG capsules and will repeat this process twice daily for a total of four doses ("High" dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (4 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining capsules
Arms:
High Dosage Group
Other names:
Lactobacillus RhamnosusGG
Size
182
Primary endpoint
Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter
(SA1) day of urine collection
Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter
(SA1) day 1 post urine collection
Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter
(SA1) day 2 post urine collection
Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter
(SA1) day 3 post urine collection
Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter
(SA2) Weekly up to 29 months
Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter
(SA2) day 1 of intervention
Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter
(SA2) 24-48 hours after intervention completion
Change in Urine white blood cell count
(SA1) day 1 post urine collection
Change in Urine white blood cell count
(SA1) 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
(SA1)day 1 post urine collection
Change in Urine Nitrite
(SA1)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
(SA1)day 1 post urine collection
Change in Urine NGAL
(SA1)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
(SA1)day 1 post urine collection
Change in Cultivable Bacteria
(SA1)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
(SA1)day 1 post urine collection
Change in Urine microbiome composition
(SA1)day 14 post urine collection
Change in Urine microbiome composition
(SA 2) day 1 of intervention
Change in Urine microbiome composition
(SA 2) 24-48 hours after intervention completion
International SCI Lower Urinary Tract Function Basic Data Set
Day 1
International SCI Core Data Set
Day 1
NINDS Medical History CDE:
Day 1
NINDS Prior and Concomitant Medications CDE
Day 1
Eligibility criteria
Inclusion Criteria:
* SCI at least 1-year duration;
* Neurogenic bladder;
* Utilizing intermittent catheterization for bladder management;
* Women must be premenopausal and not currently menstruating;
* Community dwelling
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 total at least 1-year post-SCI. 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