Intravesical Lactobacillus crispatus for urinary health in people with neurogenic bladder
Official title: Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation
Run by Medstar Health Research Institute · NCT07308808 · Data updated 2026-11-12
This study will test whether putting Lactobacillus crispatus into the bladder can help reduce urinary symptoms and urinary tract infections in adults with neurogenic lower urinary tract dysfunction who use intermittent catheters.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Medstar Health Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Status | Recruiting |
| Started | September 9, 2025 |
| Main results expected | March 30, 2027 |
| Study ends | March 30, 2027 |
| Registry record updated | December 30, 2025 |
| Trial ID | NCT07308808 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults age 18 or older with spinal cord injury for at least six months, diagnosed neurogenic lower urinary tract dysfunction, living in the community and using intermittent catheterization are the ideal candidates.
✕Probably not a fit
People using prophylactic intravesical antimicrobials, recent oral or IV antibiotics (within 2 weeks), pregnant individuals, those with other genitourinary pathology, or those with indwelling catheters are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a 23-day early-phase pilot comparative study that compares two intravesical instillations of Lactobacillus crispatus in saline to saline alone in adults with neurogenic bladder due to spinal cord injury who use intermittent catheterization. Participants will collect daily urinary symptom surveys and home urine samples for DNA sequencing (daily on days 1-7, then every 48 hours from days 11-23) and will ship samples to Loyola University for microbiome analysis. The protocol includes two overnight bladder instillations on days 8 and 9 and focuses on safety, tolerability, and identification of bactericidal compounds produced by urinary L. crispatus that kill uropathogenic E. coli. Outcomes include daily symptom scores and changes in the urinary microbiome, with safety monitoring throughout the follow-up period.
Why it matters
Potential benefit: If successful, the approach could offer an antibiotic-sparing option that reduces UTI symptoms and shifts the urinary microbiome toward protective bacteria for people with neurogenic bladder.
How similar studies have gone: Some prior work with lactobacilli in vaginal or urinary microbiome contexts suggests potential benefit, but intravesical use of L. crispatus is largely novel and only minimally tested to date.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Medstar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States Recruiting
Study contacts
- Principal investigator: Suzanne Groah, MD — MedStar National Rehabilitation Hospital
- Study coordinator: Emily Leonard, PhD
- Email: emily.m.leonard@medstar.net
- Phone: 202-877-1844
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.