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NCT Number: NCT07308808

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 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.

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Key information

Conditions

Spinal Cord Injuries (SCI) Central Nervous System Diseases Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Nervous System Diseases Neurogenic Bladder Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Urinary Bladder Diseases Urinary Bladder, Neurogenic Urinary Tract Infection (Diagnosis) Urinary Tract Infections Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

The investigators will conduct a 23-day pilot comparative study of L. crispatus instillation in 0.9% Sodium Chloride solution (saline) vs. saline solution only. Urine samples will be self-collected with a new or unused intermittent catheter and urinary symptoms will be monitored daily using the Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter (USQNB-IC). The investigators will obtain daily USQNB-IC electronically and urine samples for DNA sequencing for 7 consecutive days, and every 48 hours from days 11-23. The USQNB-IC will be completed on a daily basis until Day 23. On days 1-7, subjects will collect and freeze a daily urine sample (first urine of the day) in their home. On days 8 and 9, subjects will instill L. crispatus mixed in saline or saline solution only into their bladders immediately following the final catheterization of the day. Thus, each instillation will remain in the bladder overnight, and each instillation will occur ~24 hours (+/- 2 hours) apart. Starting on day 11, subjects will collect and freeze urine samples in their home every 48 hours, ending on day 23. Subjects will complete the USQNB-IC daily until day 23. At the end of the 23-day period, subjects will be given shipping materials including dry ice to assemble and overnight ship all the samples to Loyola University in Chicago, IL for processing, sequencing and analysis using FedEx at home pick-up. Staff at Loyola University Chicago are proficient and experienced in collecting and preparing urine samples for testing from research subjects. On Day 23, subjects will complete one final USQNB-IC and urine sample.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter

    Time frame: Daily for 23 days

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

  2. 16S rRNA gene sequencing

    Time frame: days 1-7

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

  3. 16S rRNA gene sequencing

    Time frame: alternating days 11-23

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

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Leonard, PhD

CONTACT

[email protected]

202-877-1844

Inger Ljungberg, MPH

CONTACT

[email protected]

202-877-1694

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Collaborators

  • Loyola University

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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