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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07308808
The ClinicalTrials.gov registry entry for NCT07308808 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 90-participant average among 16 other Neurogenic Bladder trials with a reported enrollment target (56% lower). The listed sponsor is Medstar Health Research Institute, which has 115 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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