Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury

  • STATUS
    Recruiting
  • participants needed
    182
  • sponsor
    Medstar Health Research Institute
Updated on 13 August 2022
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, Trauma, bladder disorder, Spinal Cord Disorders, Spinal Cord Injuries, Myelopathy, Bladder Disorders, Wounds
Treatment Culturelle 10 Billion CFU Capsule (2 doses), Culturelle 10 Billion CFU Capsule (4 doses)
Clinical Study IdentifierNCT04373512
SponsorMedstar Health Research Institute
Last Modified on13 August 2022

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