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

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ClinicalTrials.gov Identifier: NCT04323735
Recruitment Status : Recruiting
First Posted : March 26, 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
Neurogenic Bladder Drug: Culturelle 10 Billion CFU Capsule 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.

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).

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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 with NLUTD at least 6 months and who use IDC for bladder management. 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 for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Low Dosage
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 ]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
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.
Other Name: Lactobacillus Rhamnosus GG

Active Comparator: High dosage
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 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
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.
Other Name: Lactobacillus Rhamnosus GG




Primary Outcome Measures :
  1. Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [ Time Frame: (SA 1) day of urine collection ]
    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

  2. Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [ Time Frame: (SA 1) day 1 post urine collection ]
    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

  3. Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [ Time Frame: (SA 1) day 2 post urine collection ]
    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

  4. Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [ Time Frame: (SA 1) day 3 post urine collection ]
    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

  5. Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [ Time Frame: (SA 2) Weekly up to 29 months ]
    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes

  6. Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [ Time Frame: (SA 2) day 1 of intervention (low or high dose) ]
    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

  7. Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [ Time Frame: (SA 2) day 2 of intervention (low or high dose) ]
    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes

  8. Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [ Time Frame: (SA 2) day 3 of intervention (low or high dose) ]
    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes

  9. Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [ Time Frame: (SA 2) day 4 of intervention (low or high dose) ]
    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes

  10. Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [ Time Frame: (SA 2) day 5 of intervention (high dose only) ]
    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes

  11. Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter [ Time Frame: (SA 2) 24-48 hours after intervention completion ]
    Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

  12. Change in Urine white blood cell count [ Time Frame: (SA 1) day 1 post urine collection ]
    urinalysis. (local urine collection participants only)

  13. Change in Urine white blood cell count [ Time Frame: (SA 1) day 14 post urine collection ]
    urinalysis. (local urine collection participants only)

  14. Change in Urine white blood cell count [ Time Frame: (SA 2) day 1 of intervention ]
    urinalysis. (local urine collection participants only)

  15. Change in Urine white blood cell count [ Time Frame: (SA 2) 24-48 hours after intervention completion ]
    urinalysis. (local urine collection participants only)

  16. Change in Urine Nitrite [ Time Frame: (SA 1) day 1 post urine collection ]
    urinalysis. (local urine collection participants only)

  17. Change in Urine Nitrite [ Time Frame: (SA 1) day 14 post urine collection ]
    urinalysis. (local urine collection participants only)

  18. Change in Urine Nitrite [ Time Frame: (SA 2) day 1 of intervention ]
    urinalysis. (local urine collection participants only)

  19. Change in Urine Nitrite [ Time Frame: (SA 2) 24-48 hours after intervention completion ]
    urinalysis. (local urine collection participants only)

  20. Change in Urine NGAL [ Time Frame: (SA 1) day 1 post urine collection ]
    Urine NGAL. (local urine collection participants only)

  21. Change in Urine NGAL [ Time Frame: (SA 1) day 14 post urine collection ]
    Urine NGAL. (local urine collection participants only)

  22. Change in Urine NGAL [ Time Frame: (SA 2) day 1 of intervention ]
    Urine NGAL. (local urine collection participants only)

  23. Change in Urine NGAL [ Time Frame: (SA 2) 24-48 hours after intervention completion ]
    Urine NGAL. (local urine collection participants only)

  24. Change in Cultivable Bacteria [ Time Frame: (SA 1) day 1 post urine collection ]
    urine culture. (local urine collection participants only)

  25. Change in Cultivable Bacteria [ Time Frame: (SA 1) day 14 post urine collection ]
    urine culture. (local urine collection participants only)

  26. Change in Cultivable Bacteria [ Time Frame: (SA 2) day 1 of intervention ]
    urine culture. (local urine collection participants only)

  27. Change in Cultivable Bacteria [ Time Frame: (SA 2) 24-48 hours after intervention completion ]
    urine culture. (local urine collection participants only)

  28. Change in Urine microbiome composition and function [ Time Frame: (SA 1) day 1 post urine collection ]
    Next generation sequencing for microbiome composition. (local urine collection participants only)

  29. Change in Urine microbiome composition and function [ Time Frame: (SA 1) day 14 post urine collection ]
    Next generation sequencing for microbiome composition. (local urine collection participants only)

  30. Change in Urine microbiome composition and function [ Time Frame: (SA 2) day 1 of intervention ]
    Next generation sequencing for microbiome composition. (local urine collection participants only)

  31. Change in Urine microbiome composition and function [ Time Frame: (SA 2) 24-48 hours after intervention completion ]
    Next generation sequencing for microbiome composition. (local urine collection participants only)

  32. NINDS Medical History CDE: [ Time Frame: Baseline ]
    A brief medical history using body system categories

  33. Medical History Form [ Time Frame: Baseline ]
    Medical history of participant

  34. International SCI Lower Urinary Tract Function Basic Data Set [ Time Frame: Baseline ]
    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.

  35. NINDS Prior and Concomitant Medications CDE [ Time Frame: Baseline ]
    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



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:

  • 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.

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): NCT04323735


Contacts
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Contact: Amanda K Rounds, PhD 202-877-1591 Amanda.K.Rounds@medstar.net
Contact: Inger H Ljungberg 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: NCT04323735    
Other Study ID Numbers: STUDY00001782
First Posted: March 26, 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:
Indwelling catheter
Foley catheter
Suprapubic Catheter
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases