Actively Recruiting
Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation
Led by Medstar Health Research Institute · Updated on 2025-12-30
40
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
Sponsors
M
Medstar Health Research Institute
Lead Sponsor
L
Loyola University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to determine whether Lactobacillus crispatus strains isolated from the lower urinary tracts of adult women can be used as an antibiotic-sparing treatment for urinary symptoms and urinary tract infection (UTI) among adults with neurogenic lower urinary tract dysfunction (NLUTD). The main question\[s\] it aims to answer are: 1. To identify soluble bactericidal compounds produced by urinary isolates of L. crispatus that kill uropathogenic E. coli (UPEC). 2. To determine if intravesical instillation of L. crispatus is safe and well tolerated in adults with NLUTD due to SCI who use intermittent catheterization (IC). If there is a comparison group: Researchers will compare L. Crispatus to standard care saline to see if there is a difference in urinary symptoms and urinary microbiome. Participants will be asked to complete daily symptom surveys, complete 2 bladder instillations, and collect, freeze, and return 14 urine samples.
CONDITIONS
Official Title
Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Spinal cord injury lasting at least 6 months
- Neurogenic lower urinary tract dysfunction
- Using intermittent catheterization for bladder management
- Living in the community
You will not qualify if you...
- Use of prophylactic antibiotics
- Instillation of intravesical antimicrobials to prevent urinary tract infection
- Psychological or psychiatric conditions affecting ability to follow instructions
- Use of oral or intravenous antibiotics in the past 2 weeks
- Pregnancy
- Known genitourinary conditions beyond neurogenic lower urinary tract dysfunction
- Participation in another study that could affect results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Medstar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
Research Team
E
Emily Leonard, PhD
CONTACT
I
Inger Ljungberg, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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