Recruiting
Early Phase 1

L. Crispatus

Sponsor:

Medstar Health Research Institute

Code:

NCT07308808

Conditions

Spinal Cord Injuries (SCI)

Neurogenic Bladder

Urinary Tract Infection (Diagnosis)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lactobacillus Crispatus

Saline bladder wash

Study Details

Brief 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.

Conditions

Spinal Cord Injuries (SCI)

Neurogenic Bladder

Urinary Tract Infection (Diagnosis)

Study ID

NCT07308808

Start date

Sep 9, 2025

Status verified date

Dec, 2025

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

Primary outcome measure

  • Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter [ Time Frame: Daily for 23 days ]
  • 16S rRNA gene sequencing [ Time Frame: days 1-7 ]
  • 16S rRNA gene sequencing [ Time Frame: alternating days 11-23 ]

Central Contacts and Locations

Central contacts

Emily Leonard, PhD

202-877-1844emily.m.leonard@medstar.net

Inger Ljungberg, MPH

202-877-1694Inger.H.Ljungberg@medstar.net

Locations

Medstar National Rehabilitation Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Emily Leonard, PhD

202-877-1844emily.m.leonard@medstar.net

Inger Ljungberg, MPH

202-877-1694Inger.H.Ljungberg@medstar.net

More Information

Sponsor

Medstar Health Research Institute

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2025-12-30.