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Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation

NCT ID: NCT07308808

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-09

Study Completion Date

2027-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lactobacillus Crispatus

Intervention Type 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

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.

Group Type OTHER

Saline bladder wash

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Loyola University

OTHER

Sponsor Role collaborator

Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suzanne Groah, MD

Role: PRINCIPAL_INVESTIGATOR

MedStar National Rehabilitation Hospital

Locations

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Medstar National Rehabilitation Hospital

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emily Leonard, PhD

Role: CONTACT

Phone: 202-877-1844

Email: [email protected]

Inger Ljungberg, MPH

Role: CONTACT

Phone: 202-877-1694

Email: [email protected]

Facility Contacts

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Emily Leonard, PhD

Role: primary

Inger Ljungberg, MPH

Role: backup

Other Identifiers

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7337853

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00008367

Identifier Type: -

Identifier Source: org_study_id