Safety and Microbiome Study of Lactobacillus Crispatus Bladder Instillation for Adults with Neurogenic Bladder and Spinal Cord Injury

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.

Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation