Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• SCI with at least 6-month duration

• NLUTD

• Utilizing intermittent catheterization for bladder management

• Community dwelling

Locations
United States
Washington, D.c.
Medstar National Rehabilitation Hospital
RECRUITING
Washington D.c.
Contact Information
Primary
Emily Leonard, PhD
emily.m.leonard@medstar.net
202-877-1844
Backup
Inger Ljungberg, MPH
Inger.H.Ljungberg@medstar.net
202-877-1694
Time Frame
Start Date: 2025-09-09
Estimated Completion Date: 2027-03-30
Participants
Target number of participants: 40
Treatments
Experimental: Lactobacillus Crispatus bladder wash
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.
Sponsors
Collaborators: Loyola University
Leads: Medstar Health Research Institute

This content was sourced from clinicaltrials.gov