Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07308808 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07308808
Lead Sponsor Medstar Health Research Institute
Collaborators: Loyola University
Conditions
(from sponsor)		 Spinal Cord Injuries (SCI), Neurogenic Bladder, Urinary Tract Infection (Diagnosis)
Related terms Disease, Spinal Cord Injuries, Urinary Bladder, Neurogenic, Urinary Tract Infections
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov