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
N/A
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
Researchers are evaluating whether strains of Lactobacillus crispatus taken from the lower urinary tracts of adult women can serve as an alternative to antibiotics for urinary symptoms and urinary tract infections in adults with neurogenic lower urinary tract dysfunction (NLUTD) caused by spinal cord injury. This early phase 1 clinical trial aims to identify antibacterial compounds from L. crispatus that can kill harmful E. coli bacteria and to assess if bladder instillation of L. crispatus is safe and well tolerated among adults using intermittent catheterization. The study compares two groups: one receiving bladder instillations of L. crispatus mixed in saline and the other receiving saline alone. Participants will self-administer two doses of their assigned solution via intermittent catheterization on consecutive nights, with each dose remaining in the bladder overnight. The trial lasts 23 days, including periods of daily urine sample collection, symptom surveys, and microbiome analysis. Participants will collect and freeze urine samples at home daily for the first 7 days, then every other day from days 11 to 23. They will complete a daily urinary symptom questionnaire throughout the 23-day period. All samples will be shipped to the research center for DNA sequencing and analysis. The main outcomes measured include urinary symptoms and bacterial populations in the urine, monitored daily to evaluate the effects and safety of the treatments.
CONDITIONS
Brief Title
Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of spinal cord injury lasting at least 6 months
- Presence of neurogenic lower urinary tract dysfunction
- Use of intermittent catheterization for bladder management
- Living in the community (not hospitalized)
You will not qualify if you...
- Use of prophylactic antibiotics
- Instillation of intravesical antimicrobials to prevent urinary tract infection
- Psychological or psychiatric conditions that affect ability to follow instructions
- Use of oral or intravenous antibiotics in the past 2 weeks
- Pregnancy
- Known genitourinary problems beyond neurogenic lower urinary tract dysfunction
- Participation in another study that could affect this trial's results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 23 days
Participants will instill Lactobacillus crispatus mixed with saline or saline only into their bladder after the last catheterization at bedtime on two consecutive days. Urine samples will be self-collected and urinary symptoms monitored daily throughout the treatment period.
Daily self-collection of urine samples and daily symptom questionnaire completion; 2 in-home instillations on consecutive days
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
I
Inger Ljungberg, MPH
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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