RecruitingEarly Phase 1NCT07308808

Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation

Sponsor

Medstar Health Research Institute

Enrollment

40 participants

Start Date

Sep 9, 2025

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injuries (SCI)Neurogenic Bladder Urinary Tract Infection (Diagnosis)

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

Min Age: 18 Years

Inclusion Criteria5

Age ≥ 18 years
SCI with at least 6-month duration
NLUTD
Utilizing intermittent catheterization for bladder management
Community dwelling

Exclusion Criteria7

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

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Interventions

DRUGLactobacillus Crispatus

L. crispatus mixed with normal saline and instilled into the bladder will be used for intervention group. Subjects in the intervention group will be instructed to mix the contents of the applicator (by depressing the plunger, which extrudes the L. crispatus powder) into 45 cc of sterile 0.9% saline. After mixing, subjects will draw up the 45cc liquid L. crispatus mixture into a 60cc catheter tip syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Subjects will receive 2 doses (each in separate applicators) of L.crispatus and will repeat this process the following night 24 hours (+/- 2 hours) apart.

OTHERSaline bladder wash

Subjects will draw up the 45cc sterile saline into a 60cc catheter tip syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Subjects will receive 2 doses of saline and will repeat this process the following night 24 hours (+/- 2 hours) apart.