RecruitingPhase 2NCT04323735

Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters

Sponsor

Medstar Health Research Institute

Enrollment

182 participants

Start Date

Jan 10, 2020

Study Type

INTERVENTIONAL

Conditions

Neurogenic Bladder

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria6

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.

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Interventions

DRUGCulturelle 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.