Overview

Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury

Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medstar Health Research Institute
Collaborator:
Children's National Research Institute
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.