Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04323735

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Neurogenic Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases

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

Location status: Recruiting

Location contact

Amanda Rounds, PhD

CONTACT

[email protected]

202-877-1591

Inger Ljungberg, MPH

CONTACT

[email protected]

202 877-1694

Suzanne Groah, MD,MSPH

PRINCIPAL_INVESTIGATOR

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.

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Culturelle 10 Billion CFU Capsule

Drug

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 names: Lactobacillus Rhamnosus GG

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda K Rounds, PhD

CONTACT

[email protected]

202-877-1591

Inger H Ljungberg

CONTACT

[email protected]

202-877-1694

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
2026
Study completion
2026
First posted
Mar 26, 2020
Registry last updated
Oct 22, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.