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Intravesical LGG VS Saline Bladder Wash RCT
Sponsor: Medstar Health Research Institute
Summary
This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).
Official title: Intravesical Lactobacillus rhamnosusGG Versus Saline Bladder Wash: A Randomized, Controlled, Comparative Effectiveness Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2022-06-13
Completion Date
2026-12-31
Last Updated
2025-08-29
Healthy Volunteers
No
Conditions
Interventions
Lactobacillus RhamnosusGG
LGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. 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 intermittent catheter after the last catheterization prior to going to bed. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time), and then continue completing the USQNB-IC at the determined frequency for the phase.
Saline bladder wash
Participants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time), and then continue completing the USQNB-IC at the determined frequency for the phase.
Locations (1)
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States