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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedstar Health Research Institute

About this trial

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 criteria

Qualifiers

Neurogenic bladder for at least 6 months;

Utilizing indwelling catheterization for bladder management;

Women must be premenopausal and not currently menstruating;

Community dwelling

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Culturelle 10 Billion CFU Capsule

Treatment groups

182 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Medstar Health Research Institute

Lead sponsor

Children's National Research Institute

Collaborator