Recruiting EARLY_PHASE1 Spinal Cord Injuries (SCI)

Tests treatment safety and results for Spinal Cord Injuries (SCI)

Official title Intravesical Lactobacillus Crispatus: Clinical Safety and Microbiome Evaluation

ClinicalTrials.gov ID: NCT07308808

What this study is testing

What is Lactobacillus Crispatus?

Lactobacillus Crispatus is an investigational medicine, given as an once-daily, being studied as a potential treatment for spinal cord injuries (sci).

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

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

You likely can't join 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
See the full eligibility criteria
Who can join
  • Age ≥ 18 years
  • SCI with at least 6-month duration
  • NLUTD
  • Utilizing intermittent catheterization for bladder management
  • Community dwelling
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

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

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Washington D.C., District of Columbia, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.