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.