Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04373512
• Other study ID #: STUDY00001124
• Status: Recruiting
• Phase: Phase 2
• Start date: May 20, 2020
• Est. completion date: May 2026

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Neurogenic Bladder
• Spinal Cord Injuries
• Urinary Bladder, Neurogenic
• Wounds and Injuries

Intervention

Drug:
• Culturelle 10 Billion CFU Capsule (2 doses)
For the LGG instillation, participants will be instructed to mix the contents of 1 LGG capsule into saline. After mixing, participants will draw up the liquid LGG mixture into a syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 2 LGG capsules and will repeat this process the following night ("Low" dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (2 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining capsules
• Culturelle 10 Billion CFU Capsule (4 doses)
For the LGG instillation, participants will be instructed to mix the contents of 1 LGG capsule into saline. After mixing, participants will draw up the liquid LGG mixture into a syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 4 LGG capsules and will repeat this process twice daily for a total of four doses ("High" dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (4 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining capsules

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- Intermittent catheter	Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.	(SA1) day of urine collection
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter	Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.	(SA1) day 1 post urine collection
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter	Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.	(SA1) day 2 post urine collection
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter	Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.	(SA1) day 3 post urine collection
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter	Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.	(SA2) Weekly up to 29 months
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter	Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.	(SA2) day 1 of intervention
Primary	Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter	Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.	(SA2) 24-48 hours after intervention completion
Primary	Change in Urine white blood cell count	urinalysis	(SA1) day 1 post urine collection
Primary	Change in Urine white blood cell count	urinalysis	(SA1) day 14 post urine collection
Primary	Change in Urine white blood cell count	urinalysis	(SA 2) day 1 of intervention
Primary	Change in Urine white blood cell count	urinalysis	(SA 2) 24-48 hours after intervention completion
Primary	Change in Urine Nitrite	urinalysis	(SA1)day 1 post urine collection
Primary	Change in Urine Nitrite	urinalysis	(SA1)day 14 post urine collection
Primary	Change in Urine Nitrite	urinalysis	(SA 2) day 1 of intervention
Primary	Change in Urine Nitrite	urinalysis	(SA 2) 24-48 hours after intervention completion
Primary	Change in Urine NGAL	Urine NGAL	(SA1)day 1 post urine collection
Primary	Change in Urine NGAL	Urine NGAL	(SA1)day 14 post urine collection
Primary	Change in Urine NGAL	Urine NGAL	(SA 2) day 1 of intervention
Primary	Change in Urine NGAL	Urine NGAL	(SA 2) 24-48 hours after intervention completion
Primary	Change in Cultivable Bacteria	urine culture	(SA1)day 1 post urine collection
Primary	Change in Cultivable Bacteria	urine culture	(SA1)day 14 post urine collection
Primary	Change in Cultivable Bacteria	urine culture	(SA 2) day 1 of intervention
Primary	Change in Cultivable Bacteria	urine culture	(SA 2) 24-48 hours after intervention completion
Primary	Change in Urine microbiome composition	proportion of different bacterial species	(SA1)day 1 post urine collection
Primary	Change in Urine microbiome composition	proportion of different bacterial species	(SA1)day 14 post urine collection
Primary	Change in Urine microbiome composition	proportion of different bacterial species	(SA 2) day 1 of intervention
Primary	Change in Urine microbiome composition	proportion of different bacterial species	(SA 2) 24-48 hours after intervention completion
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. Score is not associated with outcome	Day 1
Primary	International SCI Core Data Set	Includes date of injury, dates of initial hospitalization admission and discharge, neurological data. Score is not associated with outcomes	Day 1
Primary	NINDS Medical History CDE:	A brief medical history using body system categories. Score is not associated with outcomes	Day 1
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. Score is not associated with outcomes	Day 1