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Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation

ConditionsSpinal Cord Injuries (SCI)Neurogenic BladderUrinary Tract Infection (Diagnosis)
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedstar Health Research Institute

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

SCI with at least 6-month duration

NLUTD

Utilizing intermittent catheterization for bladder management

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lactobacillus Crispatus

    Drug

    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.

  • Saline bladder wash

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Lactobacillus Crispatus bladder washExperimental treatment 1 intervention
Group B: Saline Bladder WashOther 1 intervention

Trial outcomes

Primary outcomes

1

Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter

Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.

Time frame
Daily for 23 days
2

16S rRNA gene sequencing

Changes in the presence and relative abundance of uropathogens and L. crispatus and saline solution

Time frame
days 1-7
3

16S rRNA gene sequencing

Changes in the presence and relative abundance of uropathogens and L. crispatus and saline solution

Time frame
alternating days 11-23

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medstar Health Research Institute

Lead sponsor

Loyola University

Collaborator

Source ClinicalTrials.gov
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