Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGEarly Phase 1INTERVENTIONAL

Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥ 18 years - SCI with at least 6-month duration - NLUTD - Utilizing intermittent catheterization for bladder management - Community dwelling Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Lactobacillus 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.

OTHER

Saline 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.

Locations (1)

Medstar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States