- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04373512
Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury
Study Overview
Status
Conditions
Intervention / Treatment
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.
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Amanda K Rounds, PhD
- Phone Number: (202) 877-1591
- Email: Amanda.K.Rounds@medstar.net
Study Contact Backup
- Name: Inger H Ljungberg, MPH
- Phone Number: (202) 877-1694
- Email: inger.h.ljungberg@medstar.net
Study Locations
-
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Recruiting
- MedStar National Rehabilitation Hospital
-
Contact:
- Amanda Rounds, PhD
- Phone Number: 202-877-1591
- Email: amanda.k.rounds@medstar.net
-
Contact:
- Inger Ljungberg, MPH
- Phone Number: 202 877-1694
- Email: inger.h.ljungberg@medstar.net
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Principal Investigator:
- Suzanne Groah, MD,MSPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low Dosage Group
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 intermitent catheter.
Participants will receive 2 LGG capsules and will repeat this process the following day ("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 kits (including LGG®).
Participants will be instructed to complete the USQNB-IDC weekly until study completion.
|
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
Other Names:
|
Experimental: High Dosage Group
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 intermittent catheter.
Participants will receive 4 LGG capsules and will repeat this process the following day twice 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 kits (including LGG®).
Participants will be instructed to complete the USQNB-IDC weekly until study completion.
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter
Time Frame: (SA1) day of urine collection
|
Will measure change in urinary symptoms for those that use an intermittent catheter.
Higher scores may mean worse outcomes.
|
(SA1) day of urine collection
|
Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter
Time Frame: (SA1) day 1 post urine collection
|
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
|
Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter
Time Frame: (SA1) day 2 post urine collection
|
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
|
Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter
Time Frame: (SA1) day 3 post urine collection
|
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
|
Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter
Time Frame: (SA2) Weekly up to 29 months
|
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
|
Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter
Time Frame: (SA2) day 1 of intervention
|
Will measure change in urinary symptoms for those that use an intermittent catheter.
Higher scores may mean worse outcomes.
|
(SA2) day 1 of intervention
|
Urinary Symptom Questionnaire for Neurogenic Bladder- Intermittent catheter
Time Frame: (SA2) 24-48 hours after intervention completion
|
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
|
Change in Urine white blood cell count
Time Frame: (SA1) day 1 post urine collection
|
urinalysis
|
(SA1) day 1 post urine collection
|
Change in Urine white blood cell count
Time Frame: (SA1) day 14 post urine collection
|
urinalysis
|
(SA1) day 14 post urine collection
|
Change in Urine white blood cell count
Time Frame: (SA 2) day 1 of intervention
|
urinalysis
|
(SA 2) day 1 of intervention
|
Change in Urine white blood cell count
Time Frame: (SA 2) 24-48 hours after intervention completion
|
urinalysis
|
(SA 2) 24-48 hours after intervention completion
|
Change in Urine Nitrite
Time Frame: (SA1)day 1 post urine collection
|
urinalysis
|
(SA1)day 1 post urine collection
|
Change in Urine Nitrite
Time Frame: (SA1)day 14 post urine collection
|
urinalysis
|
(SA1)day 14 post urine collection
|
Change in Urine Nitrite
Time Frame: (SA 2) day 1 of intervention
|
urinalysis
|
(SA 2) day 1 of intervention
|
Change in Urine Nitrite
Time Frame: (SA 2) 24-48 hours after intervention completion
|
urinalysis
|
(SA 2) 24-48 hours after intervention completion
|
Change in Urine NGAL
Time Frame: (SA1)day 1 post urine collection
|
Urine NGAL
|
(SA1)day 1 post urine collection
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Change in Urine NGAL
Time Frame: (SA1)day 14 post urine collection
|
Urine NGAL
|
(SA1)day 14 post urine collection
|
Change in Urine NGAL
Time Frame: (SA 2) day 1 of intervention
|
Urine NGAL
|
(SA 2) day 1 of intervention
|
Change in Urine NGAL
Time Frame: (SA 2) 24-48 hours after intervention completion
|
Urine NGAL
|
(SA 2) 24-48 hours after intervention completion
|
Change in Cultivable Bacteria
Time Frame: (SA1)day 1 post urine collection
|
urine culture
|
(SA1)day 1 post urine collection
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Change in Cultivable Bacteria
Time Frame: (SA1)day 14 post urine collection
|
urine culture
|
(SA1)day 14 post urine collection
|
Change in Cultivable Bacteria
Time Frame: (SA 2) day 1 of intervention
|
urine culture
|
(SA 2) day 1 of intervention
|
Change in Cultivable Bacteria
Time Frame: (SA 2) 24-48 hours after intervention completion
|
urine culture
|
(SA 2) 24-48 hours after intervention completion
|
Change in Urine microbiome composition
Time Frame: (SA1)day 1 post urine collection
|
proportion of different bacterial species
|
(SA1)day 1 post urine collection
|
Change in Urine microbiome composition
Time Frame: (SA1)day 14 post urine collection
|
proportion of different bacterial species
|
(SA1)day 14 post urine collection
|
Change in Urine microbiome composition
Time Frame: (SA 2) day 1 of intervention
|
proportion of different bacterial species
|
(SA 2) day 1 of intervention
|
Change in Urine microbiome composition
Time Frame: (SA 2) 24-48 hours after intervention completion
|
proportion of different bacterial species
|
(SA 2) 24-48 hours after intervention completion
|
International SCI Lower Urinary Tract Function Basic Data Set
Time Frame: Day 1
|
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
|
International SCI Core Data Set
Time Frame: Day 1
|
Includes date of injury, dates of initial hospitalization admission and discharge, neurological data.
Score is not associated with outcomes
|
Day 1
|
NINDS Medical History CDE:
Time Frame: Day 1
|
A brief medical history using body system categories.
Score is not associated with outcomes
|
Day 1
|
NINDS Prior and Concomitant Medications CDE
Time Frame: Day 1
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Suzanne Groah, MD, MSPH, MedStar National Rehabilitation Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Urologic Diseases
- Urinary Bladder Diseases
- Neurologic Manifestations
- Trauma, Nervous System
- Spinal Cord Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Wounds and Injuries
- Spinal Cord Injuries
- Urinary Bladder, Neurogenic
Other Study ID Numbers
- STUDY00001124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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