Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury

  • STATUS
    Recruiting
  • End date
    Aug 25, 2022
  • participants needed
    182
  • sponsor
    Medstar Health Research Institute
Updated on 25 January 2021
spinal cord
spinal cord disorder
urinary symptoms
neurogenic bladder
intermittent catheterization

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.

SPECIFIC AIM 1

2 urine samples (sampling at least 2 weeks apart) for urinalysis, urine culture, uNGAL, and NGS (16S rRNA and shotgun) under the same conditions. In addition to completing the USQNB-IC prior to urine collection, participants will complete the USQNB-IC 3 days after urine collection

SPECIFIC AIM 2 Intravesical LGG dose (group: high or low) will be obtained, USQNB-IC, urine collection for urinalysis, culture, NGAL and next generation sequencing as described above. And patient satisfaction questions.

Details
Condition Neurogenic Bladder, Spinal Cord Injury, Myelopathy, Trauma, bladder disorder, Spinal Cord Injuries, Wounds, Spinal Cord Disorders, Bladder Disorders
Treatment Culturelle 10 Billion CFU Capsule (2 doses), Culturelle 10 Billion CFU Capsule (4 doses)
Clinical Study IdentifierNCT04373512
SponsorMedstar Health Research Institute
Last Modified on25 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: Spinal Cord Injuries or bladder disorder or Myelopathy or Spinal Cord Injury or Neurogenic Bladder or Wounds or Trauma or Spinal Cord Disorders or Bla...?
Do you have any of these conditions: bladder disorder or Neurogenic Bladder or Bladder Disorders or Myelopathy or Spinal Cord Injuries or Wounds or Spinal Cord Disorders or Trauma or Spin...?
SCI at least 1-year duration
Neurogenic bladder
Utilizing intermittent catheterization for bladder management
Women must be premenopausal and not currently menstruating
Community dwelling

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
Clear my responses

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