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

Overview

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.

Detailed 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).

Interventions

• Drug Culturelle 10 Billion CFU Capsule
  LGG® (Culturelle Probiotic with Lactobacillus RhamnosusGG, shown to produce the largest amount of antibacterial substances against pathogenic bacteria) will be used. For the LGG® instillation, participants will be instructed to mix the contents of 1 LGG capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG mixture into a 60cc syringe and instill via the indwelling catheter (the catheter will not be changed as this would represent 2 interventions). Pa

Primary outcome measures

• Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [Time frame: (SA 1) day of urine collection]
• Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [Time frame: (SA 1) day 1 post urine collection]
• Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [Time frame: (SA 1) day 2 post urine collection]
• Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [Time frame: (SA 1) day 3 post urine collection]
• Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [Time frame: (SA 2) Weekly up to 29 months]
• Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [Time frame: (SA 2) day 1 of intervention (low or high dose)]
• Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [Time frame: (SA 2) day 2 of intervention (low or high dose)]
• Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [Time frame: (SA 2) day 3 of intervention (low or high dose)]
• Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [Time frame: (SA 2) day 4 of intervention (low or high dose)]
• Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [Time frame: (SA 2) day 5 of intervention (high dose only)]

Eligibility criteria

Inclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• MedStar National Rehabilitation Hospital — Washington D.C.

Identifiers

NCT: NCT04323735 · STUDY00001782

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗