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NCT07308808 · ClinicalTrials.gov registry record · Early Phase 1
Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation
A Early Phase 1 study of Neurogenic Bladder and Spinal Cord Injuries (SCI), sponsored by Medstar Health Research Institute.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT07308808: Recruiting Early Phase 1 study of Neurogenic Bladder and Spinal Cord Injuries (SCI), sponsored by Medstar Health Research Institute.
NCT07308808 is a Early Phase 1 study of Neurogenic Bladder and Spinal Cord Injuries (SCI) that is actively recruiting participants, run by Medstar Health Research Institute. The registered enrollment target is 40 participants, below the 90-participant average among 16 other Neurogenic Bladder trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07308808, a Early Phase 1 study of Neurogenic Bladder and Spinal Cord Injuries (SCI), is actively recruiting participants, sponsored by Medstar Health Research Institute.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
Conditions Studied
Interventions
- DRUG Lactobacillus Crispatus
- OTHER Saline bladder wash
Study Locations (1)
District of Columbia
- Medstar National Rehabilitation Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-09-09 |
| Est. Completion | 2027-03-30 |
| Phase | Early Phase 1 |
What NCT07308808 shows while recruiting
NCT07308808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 90-participant average among 16 other Neurogenic Bladder trials with a reported enrollment target (56% lower).
The record links to 3 conditions, with Neurogenic Bladder appearing as the primary indexed condition, and to 2 interventions - of which Lactobacillus Crispatus is the first listed.
NCT07308808 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT07308808 about?
NCT07308808 is a clinical study titled "Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation". 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 dysfunc...
What is the current status of trial NCT07308808?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2025-09-09. Estimated completion is 2027-03-30.
What conditions does trial NCT07308808 study?
This clinical trial studies the following conditions: Neurogenic Bladder, Spinal Cord Injuries (SCI), Urinary Tract Infection (Diagnosis).
What interventions are being tested in trial NCT07308808?
The interventions under investigation include: Lactobacillus Crispatus (DRUG), Saline bladder wash (OTHER).
Who is sponsoring clinical trial NCT07308808?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07308808 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07308808's enrollment target sits among peer trials
40 10th of 16 higher than 7 of 16 other Neurogenic Bladder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurogenic Bladder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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