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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04373512
Other study ID # STUDY00001124
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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