Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedstar Health Research Institute
About this trial
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
Qualifiers
Age ≥ 18 years
SCI with at least 6-month duration
NLUTD
Utilizing intermittent catheterization for bladder management
Disqualifiers
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
Trial design
Treatments tested in this trial
- Lactobacillus Crispatus
- Saline bladder wash
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Medstar Health Research Institute
Lead sponsor
Loyola University
Collaborator
Source ClinicalTrials.gov