NCT07308808 Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation
| NCT ID | NCT07308808 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Medstar Health Research Institute |
| Condition | Spinal Cord Injuries (SCI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-09-09 |
| Primary Completion | 2027-03-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * SCI with at least 6-month duration * NLUTD * Utilizing intermittent catheterization for bladder management * Community dwelling Exclusion Criteria: * Use of prophylactic antibiotics * Instillation of intravesical antimicrobials to prevent UTI * Psychological or psychiatric conditions influencing the ability to follow instructions * Use of oral or IV antibiotics in the past 2 weeks * Pregnancy * Known genitourinary pathology beyond NLUTD * Participation in another study that could confound results of the proposed study