Neurogenic BladderPhase 2NCT04323735
Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters
A Phase 2 study testing Culturelle 10 Billion CFU Capsule in people with Neurogenic Bladder, run by Medstar Health Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bladder
- What is being tested?
- Culturelle 10 Billion CFU Capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
About this study
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.
Read the 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).
- Conditions
- Neurogenic Bladder
- Being tested
- Culturelle 10 Billion CFU Capsule
- Keywords
- Indwelling catheter, Foley catheter, Suprapubic Catheter
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturelle 10 Billion CFU CapsuleDrug
Also called Lactobacillus Rhamnosus GG
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Dosage | Active comparator | 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. Receives: Drug: Culturelle 10 Billion CFU Capsule |
| High dosage | Active comparator | 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. Receives: Drug: Culturelle 10 Billion CFU Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Measured: (SA 1) day of urine collection
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Measured: (SA 1) day 1 post urine collection
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Measured: (SA 1) day 2 post urine collection
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Measured: (SA 1) day 3 post urine collection
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes
Measured: (SA 2) Weekly up to 29 months
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Measured: (SA 2) day 1 of intervention (low or high dose)
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes
Measured: (SA 2) day 2 of intervention (low or high dose)
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes
Measured: (SA 2) day 3 of intervention (low or high dose)
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes
Measured: (SA 2) day 4 of intervention (low or high dose)
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes
Measured: (SA 2) day 5 of intervention (high dose only)
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter
Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)
Measured: (SA 2) 24-48 hours after intervention completion
Change in Urine white blood cell count
urinalysis. (local urine collection participants only)
Measured: (SA 1) day 1 post urine collection
Change in Urine white blood cell count
urinalysis. (local urine collection participants only)
Measured: (SA 1) day 14 post urine collection
Change in Urine white blood cell count
urinalysis. (local urine collection participants only)
Measured: (SA 2) day 1 of intervention
Change in Urine white blood cell count
urinalysis. (local urine collection participants only)
Measured: (SA 2) 24-48 hours after intervention completion
Change in Urine Nitrite
urinalysis. (local urine collection participants only)
Measured: (SA 1) day 1 post urine collection
Change in Urine Nitrite
urinalysis. (local urine collection participants only)
Measured: (SA 1) day 14 post urine collection
Change in Urine Nitrite
urinalysis. (local urine collection participants only)
Measured: (SA 2) day 1 of intervention
Change in Urine Nitrite
urinalysis. (local urine collection participants only)
Measured: (SA 2) 24-48 hours after intervention completion
Change in Urine NGAL
Urine NGAL. (local urine collection participants only)
Measured: (SA 1) day 1 post urine collection
Change in Urine NGAL
Urine NGAL. (local urine collection participants only)
Measured: (SA 1) day 14 post urine collection
Change in Urine NGAL
Urine NGAL. (local urine collection participants only)
Measured: (SA 2) day 1 of intervention
Change in Urine NGAL
Urine NGAL. (local urine collection participants only)
Measured: (SA 2) 24-48 hours after intervention completion
Change in Cultivable Bacteria
urine culture. (local urine collection participants only)
Measured: (SA 1) day 1 post urine collection
Change in Cultivable Bacteria
urine culture. (local urine collection participants only)
Measured: (SA 1) day 14 post urine collection
Change in Cultivable Bacteria
urine culture. (local urine collection participants only)
Measured: (SA 2) day 1 of intervention
Change in Cultivable Bacteria
urine culture. (local urine collection participants only)
Measured: (SA 2) 24-48 hours after intervention completion
Change in Urine microbiome composition and function
Next generation sequencing for microbiome composition. (local urine collection participants only)
Measured: (SA 1) day 1 post urine collection
Change in Urine microbiome composition and function
Next generation sequencing for microbiome composition. (local urine collection participants only)
Measured: (SA 1) day 14 post urine collection
Change in Urine microbiome composition and function
Next generation sequencing for microbiome composition. (local urine collection participants only)
Measured: (SA 2) day 1 of intervention
Change in Urine microbiome composition and function
Next generation sequencing for microbiome composition. (local urine collection participants only)
Measured: (SA 2) 24-48 hours after intervention completion
NINDS Medical History CDE:
A brief medical history using body system categories
Measured: Baseline
Medical History Form
Medical history of participant
Measured: Baseline
International SCI Lower Urinary Tract Function Basic Data Set
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.
Measured: Baseline
NINDS Prior and Concomitant Medications CDE
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start10 Jan 2020
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Children's National Research Institute
- Responsible party
- Sponsor
- Investigators
- Suzanne Groah, MD, MSPH, Principal investigator, MedStar National Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323735
- Sponsor's protocol ID
- STUDY00001782
- Status last verified
- Oct 2025
- First submitted
- 28 Jan 2020
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters
- ClinicalTrials.gov ID
- NCT04323735
- Acronym / sponsor ID
- STUDY00001782
- Conditions
- Neurogenic Bladder
- Keywords
- Indwelling catheter, Foley catheter, Suprapubic Catheter
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Children's National Research Institute
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Low Dosage | Active comparator | Drug: Culturelle 10 Billion CFU CapsuleFor 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. |
| High dosage | Active comparator | Drug: Culturelle 10 Billion CFU CapsuleFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturelle 10 Billion CFU CapsuleAlso: Lactobacillus Rhamnosus GGLGG® (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. | Drug | High dosage, Low Dosage |
Primary outcome
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)
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)
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)
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)
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
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)
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
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
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
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
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)
Change in Urine white blood cell count
Time frame: (SA 1) day 1 post urine collection
urinalysis. (local urine collection participants only)
Change in Urine white blood cell count
Time frame: (SA 1) day 14 post urine collection
urinalysis. (local urine collection participants only)
Change in Urine white blood cell count
Time frame: (SA 2) day 1 of intervention
urinalysis. (local urine collection participants only)
Change in Urine white blood cell count
Time frame: (SA 2) 24-48 hours after intervention completion
urinalysis. (local urine collection participants only)
Change in Urine Nitrite
Time frame: (SA 1) day 1 post urine collection
urinalysis. (local urine collection participants only)
Change in Urine Nitrite
Time frame: (SA 1) day 14 post urine collection
urinalysis. (local urine collection participants only)
Change in Urine Nitrite
Time frame: (SA 2) day 1 of intervention
urinalysis. (local urine collection participants only)
Change in Urine Nitrite
Time frame: (SA 2) 24-48 hours after intervention completion
urinalysis. (local urine collection participants only)
Change in Urine NGAL
Time frame: (SA 1) day 1 post urine collection
Urine NGAL. (local urine collection participants only)
Change in Urine NGAL
Time frame: (SA 1) day 14 post urine collection
Urine NGAL. (local urine collection participants only)
Change in Urine NGAL
Time frame: (SA 2) day 1 of intervention
Urine NGAL. (local urine collection participants only)
Change in Urine NGAL
Time frame: (SA 2) 24-48 hours after intervention completion
Urine NGAL. (local urine collection participants only)
Change in Cultivable Bacteria
Time frame: (SA 1) day 1 post urine collection
urine culture. (local urine collection participants only)
Change in Cultivable Bacteria
Time frame: (SA 1) day 14 post urine collection
urine culture. (local urine collection participants only)
Change in Cultivable Bacteria
Time frame: (SA 2) day 1 of intervention
urine culture. (local urine collection participants only)
Change in Cultivable Bacteria
Time frame: (SA 2) 24-48 hours after intervention completion
urine culture. (local urine collection participants only)
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)
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)
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)
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)
NINDS Medical History CDE:
Time frame: Baseline
A brief medical history using body system categories
Medical History Form
Time frame: Baseline
Medical history of participant
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Groah, MD, MSPH principal investigator
MedStar National Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Culturelle 10 Billion CFU Capsule in people with Neurogenic Bladder, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Symptom Questionnaire for Neurogenic Bladder- Indwelling catheter (time frame: (SA 1) day of urine collection). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.