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Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04373512
Recruitment Status : Recruiting
First Posted : May 4, 2020
Last Update Posted : August 14, 2020
Sponsor:
Collaborator:
Children's National Research Institute
Information provided by (Responsible Party):
Medstar Health Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Neurogenic Bladder Drug: Culturelle 10 Billion CFU Capsule (2 doses) Drug: Culturelle 10 Billion CFU Capsule (4 doses) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Design: Prospective, randomized pilot intervention clinical trial. Target Enrollment: 182 subjects total at least 1-year post-SCI. Setting: National sample (N=114 intervention only, no urine collection) and local Washington, DC metropolitan area (N=68 intervention + urine collection).

Controls: This is a 2-arm dose-finding pilot clinical trial, as such there is no control group.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


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.
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
Other Name: Lactobacillus RhamnosusGG

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.
Drug: 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
Other Name: Lactobacillus RhamnosusGG




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Change in Urine white blood cell count [ Time Frame: (SA1) day 1 post urine collection ]
    urinalysis

  9. Change in Urine white blood cell count [ Time Frame: (SA1) day 14 post urine collection ]
    urinalysis

  10. Change in Urine white blood cell count [ Time Frame: (SA 2) day 1 of intervention ]
    urinalysis

  11. Change in Urine white blood cell count [ Time Frame: (SA 2) 24-48 hours after intervention completion ]
    urinalysis

  12. Change in Urine Nitrite [ Time Frame: (SA1)day 1 post urine collection ]
    urinalysis

  13. Change in Urine Nitrite [ Time Frame: (SA1)day 14 post urine collection ]
    urinalysis

  14. Change in Urine Nitrite [ Time Frame: (SA 2) day 1 of intervention ]
    urinalysis

  15. Change in Urine Nitrite [ Time Frame: (SA 2) 24-48 hours after intervention completion ]
    urinalysis

  16. Change in Urine NGAL [ Time Frame: (SA1)day 1 post urine collection ]
    Urine NGAL

  17. Change in Urine NGAL [ Time Frame: (SA1)day 14 post urine collection ]
    Urine NGAL

  18. Change in Urine NGAL [ Time Frame: (SA 2) day 1 of intervention ]
    Urine NGAL

  19. Change in Urine NGAL [ Time Frame: (SA 2) 24-48 hours after intervention completion ]
    Urine NGAL

  20. Change in Cultivable Bacteria [ Time Frame: (SA1)day 1 post urine collection ]
    urine culture

  21. Change in Cultivable Bacteria [ Time Frame: (SA1)day 14 post urine collection ]
    urine culture

  22. Change in Cultivable Bacteria [ Time Frame: (SA 2) day 1 of intervention ]
    urine culture

  23. Change in Cultivable Bacteria [ Time Frame: (SA 2) 24-48 hours after intervention completion ]
    urine culture

  24. Change in Urine microbiome composition [ Time Frame: (SA1)day 1 post urine collection ]
    proportion of different bacterial species

  25. Change in Urine microbiome composition [ Time Frame: (SA1)day 14 post urine collection ]
    proportion of different bacterial species

  26. Change in Urine microbiome composition [ Time Frame: (SA 2) day 1 of intervention ]
    proportion of different bacterial species

  27. Change in Urine microbiome composition [ Time Frame: (SA 2) 24-48 hours after intervention completion ]
    proportion of different bacterial species

  28. 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

  29. 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

  30. NINDS Medical History CDE: [ Time Frame: Day 1 ]
    A brief medical history using body system categories. Score is not associated with outcomes

  31. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373512


Contacts
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Contact: Amanda K Rounds, PhD (202) 877-1591 Amanda.K.Rounds@medstar.net
Contact: Inger H Ljungberg, MPH (202) 877-1694 inger.h.ljungberg@medstar.net

Locations
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United States, District of Columbia
MedStar National Rehabilitation Hospital Recruiting
Washington, District of Columbia, United States, 20010
Contact: Amanda Rounds, PhD    202-877-1591    amanda.k.rounds@medstar.net   
Contact: Inger Ljungberg, MPH    202 877-1694    inger.h.ljungberg@medstar.net   
Principal Investigator: Suzanne Groah, MD,MSPH         
Sponsors and Collaborators
Medstar Health Research Institute
Children's National Research Institute
Investigators
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Principal Investigator: Suzanne Groah, MD, MSPH MedStar National Rehabilitation Hospital
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Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT04373512    
Other Study ID Numbers: STUDY00001124
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medstar Health Research Institute:
Intermittent Catheter
Additional relevant MeSH terms:
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Spinal Cord Injuries
Urinary Bladder, Neurogenic
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases