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

Neurogenic Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04323735
• Other study ID #: STUDY00001782
• Status: Recruiting
• Phase: Phase 2
• Start date: January 10, 2020
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Medstar Health Research Institute
• Contact: Amanda K Rounds, PhD
• Phone: 202-877-1591
• Email: Amanda.K.Rounds[@]medstar.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: September 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neurogenic Bladder
• Urinary Bladder, Neurogenic

Intervention

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). Participants will be instructed the plug their catheter for 1 hour. Participants will receive 2 or 4 LGG capsules (depending on randomization group) and will repeat this process the following day ("Low" dose) or twice daily for a total of four doses ("High" dose) according to randomization group.

Locations

Country	Name	City	State
United States	MedStar National Rehabilitation Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Health Research Institute	Children's National Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter	Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)	(SA 1) day of urine collection
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter	Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)	(SA 1) day 1 post urine collection
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter	Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)	(SA 1) day 2 post urine collection
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter	Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)	(SA 1) day 3 post urine collection
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter	Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes	(SA 2) Weekly up to 29 months
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter	Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)	(SA 2) day 1 of intervention (low or high dose)
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter	Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes	(SA 2) day 2 of intervention (low or high dose)
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter	Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes	(SA 2) day 3 of intervention (low or high dose)
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter	Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes	(SA 2) day 4 of intervention (low or high dose)
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter	Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes	(SA 2) day 5 of intervention (high dose only)
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter	Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)	(SA 2) 24-48 hours after intervention completion
Primary	Change in Urine white blood cell count	urinalysis. (local urine collection participants only)	(SA 1) day 1 post urine collection
Primary	Change in Urine white blood cell count	urinalysis. (local urine collection participants only)	(SA 1) day 14 post urine collection
Primary	Change in Urine white blood cell count	urinalysis. (local urine collection participants only)	(SA 2) day 1 of intervention
Primary	Change in Urine white blood cell count	urinalysis. (local urine collection participants only)	(SA 2) 24-48 hours after intervention completion
Primary	Change in Urine Nitrite	urinalysis. (local urine collection participants only)	(SA 1) day 1 post urine collection
Primary	Change in Urine Nitrite	urinalysis. (local urine collection participants only)	(SA 1) day 14 post urine collection
Primary	Change in Urine Nitrite	urinalysis. (local urine collection participants only)	(SA 2) day 1 of intervention
Primary	Change in Urine Nitrite	urinalysis. (local urine collection participants only)	(SA 2) 24-48 hours after intervention completion
Primary	Change in Urine NGAL	Urine NGAL. (local urine collection participants only)	(SA 1) day 1 post urine collection
Primary	Change in Urine NGAL	Urine NGAL. (local urine collection participants only)	(SA 1) day 14 post urine collection
Primary	Change in Urine NGAL	Urine NGAL. (local urine collection participants only)	(SA 2) day 1 of intervention
Primary	Change in Urine NGAL	Urine NGAL. (local urine collection participants only)	(SA 2) 24-48 hours after intervention completion
Primary	Change in Cultivable Bacteria	urine culture. (local urine collection participants only)	(SA 1) day 1 post urine collection
Primary	Change in Cultivable Bacteria	urine culture. (local urine collection participants only)	(SA 1) day 14 post urine collection
Primary	Change in Cultivable Bacteria	urine culture. (local urine collection participants only)	(SA 2) day 1 of intervention
Primary	Change in Cultivable Bacteria	urine culture. (local urine collection participants only)	(SA 2) 24-48 hours after intervention completion
Primary	Change in Urine microbiome composition and function	Next generation sequencing for microbiome composition. (local urine collection participants only)	(SA 1) day 1 post urine collection
Primary	Change in Urine microbiome composition and function	Next generation sequencing for microbiome composition. (local urine collection participants only)	(SA 1) day 14 post urine collection
Primary	Change in Urine microbiome composition and function	Next generation sequencing for microbiome composition. (local urine collection participants only)	(SA 2) day 1 of intervention
Primary	Change in Urine microbiome composition and function	Next generation sequencing for microbiome composition. (local urine collection participants only)	(SA 2) 24-48 hours after intervention completion
Primary	NINDS Medical History CDE:	A brief medical history using body system categories	Baseline
Primary	Medical History Form	Medical history of participant	Baseline
Primary	International SCI Lower Urinary Tract Function Basic Data Set	A tool to describe urinary tract impairment, awareness of need to empty the bladder, main bladder emptying method, medications used for bladder management, surgeries, and change in urinary symptoms in the past year.	Baseline
Primary	NINDS Prior and Concomitant Medications CDE	Contains whether or not the participant is taking a medication during the study protocol, name of medication, reason for medication, medication dose, frequency, start and end dates, and free text	Baseline