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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2025-09-09 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Suzanne Groah, MD
PRINCIPAL INVESTIGATOR
MedStar National Rehabilitation Hospital
Frequently Asked Questions
Who can join the NCT07308808 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injuries (SCI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07308808 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07308808 currently recruiting?
Yes, NCT07308808 is actively recruiting participants. Contact the research team at emily.m.leonard@medstar.net for enrollment information.
Where is the NCT07308808 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT07308808 clinical trial?
NCT07308808 is sponsored by Medstar Health Research Institute. The principal investigator is Suzanne Groah, MD at MedStar National Rehabilitation Hospital. The trial plans to enroll 40 participants.