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Completed

NCT Number: NCT04373512

Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurogenic Bladder Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Culturelle 10 Billion CFU Capsule (2 doses)

Drug

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: Lactobacillus RhamnosusGG

Culturelle 10 Billion CFU Capsule (4 doses)

Drug

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: Lactobacillus RhamnosusGG

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Collaborators

  • Children's National Research Institute

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 4, 2020
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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