Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters

  • STATUS
    Recruiting
  • End date
    Oct 24, 2024
  • participants needed
    182
  • sponsor
    Medstar Health Research Institute
Updated on 24 January 2021
urinary symptoms

Summary

The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical Lactobacillus RhamnosusGG (LGG) dose to be used to reduce urinary symptoms in a future clinical trial.

Description

Urinary tract infection (UTI) is the most common outpatient infection world-wide, and for people with spinal cord injury (SCI) and neurogenic bladder (NB), it is the most common infection, secondary condition, cause for emergency room visits, and infectious cause of hospitalization. Despite its prevalence, attempts to ameliorate UTI among people with SCI are stymied by long-standing diagnostic challenges which arise from evidence gaps around "gold standard" diagnostic tests (urinalysis and urine culture) that have lower sensitivity and specificity for UTI in this population. A high prevalence of chronic inflammation leading to persistence of white blood cells (WBC) in the urine confounds the utility of WBC count, pyuria, and leukocyte esterase as biomarkers for UTI; nitrites in urine indicate the presence of only specific (but not all) organisms, many of which are present to a greater extent in the urine of people with SCI; and people with SCI have a high prevalence of asymptomatic bacteriuria. These physiologic changes render the gold standard diagnostic tests less useful for identifying UTI in persons with SCI.

SA1. Estimate healthy, asymptomatic state variability of urine NGAL (uNGAL), white blood cells (uWBC), nitrite, cultivable bacteria, and the urinary microbiome.

SA2. Estimate the effect of intravesical LGG dose on urinary symptoms (primary outcome), uNGAL, uWBC, nitrites, cultivable bacteria, and the urine microbiome (secondary outcomes).

Details
Condition Neurogenic Bladder, bladder disorder, Bladder Disorders
Treatment Culturelle 10 Billion CFU Capsule
Clinical Study IdentifierNCT04323735
SponsorMedstar Health Research Institute
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Neurogenic Bladder or bladder disorder or Bladder Disorders?
Do you have any of these conditions: bladder disorder or Neurogenic Bladder or Bladder Disorders?
Neurogenic bladder for at least 6 months
Utilizing indwelling catheterization for bladder management
Women must be premenopausal and not currently menstruating
Community dwelling
physical disability

Exclusion Criteria

Use of prophylactic antibiotics
Instillation of intravesical antimicrobials to prevent UTI
Psychologic or psychiatric conditions influencing the ability to follow instructions
Use of oral or IV antibiotics within the past 2 weeks
Sexual activity within the previous 72 hours
Participation in another study with which results could be confounded
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