Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation

NCT07308808 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY000083677337853
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.To identify soluble bactericidal compounds produced by urinary isolates of L. crispatus that kill uropathogenic E. coli (UPEC).
2. 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).

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Daily for 23 days

• 16S rRNA gene sequencing

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

  days 1-7

• 16S rRNA gene sequencing

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

  alternating days 11-23

Study Arms (2)

Lactobacillus Crispatus bladder wash

EXPERIMENTAL

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.

Drug: Lactobacillus Crispatus

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.

Other: Saline bladder wash

Interventions

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.

Saline Bladder Wash

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.

Lactobacillus Crispatus bladder wash

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• SCI with at least 6-month duration
• NLUTD
• Utilizing intermittent catheterization for bladder management
• Community dwelling

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Loyola University: collaborator

Study Sites (1)

Medstar National Rehabilitation Hospital

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

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic; Urinary Tract Infections; Disease

Interventions

APF protein, Lactobacillus crispatus

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Pathologic Processes

Study Officials

• Suzanne Groah, MD

  MedStar National Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Leonard, PhD

CONTACT

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

Inger Ljungberg, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: December 30, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

US (1)