Spinal Cord InjuriesPhase 2NCT05230511
Intravesical LGG VS Saline Bladder Wash RCT
A Phase 2 study testing Lactobacillus RhamnosusGG and Saline bladder wash in people with Spinal Cord Injuries and Neurogenic Bladder, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Neurogenic Bladder
- What is being tested?
- Lactobacillus RhamnosusGG and Saline bladder wash
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2022to 31 Dec 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
- Age ≥18 years;
- SCI at least 6 months duration;
- NLUTD (as determined by their SCI physician or urologist);
- Utilizing intermittent catheterization for bladder management; and
- Community dwelling (discharged from the acute care setting).
Who cannot join
- Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux, bladder or kidney stones, etc.);
- Use of prophylactic antibiotics;
- Instillation of intravesical agents (e.g., gentamycin, saline; or Lactobacillus);
- Immunodeficiency;
- Any oral antibiotics within the past 2 weeks;
- Psychologic or psychiatric conditions influencing the ability to follow instructions;
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- Participation in another study in which results would be confounded;
- 6 months since prior exposure to intravesical LGG®; and
- Active cancer (or within 5 years) or active autoimmune disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
Allison M Maxwell, BA, (202) 877-1560, allison.m.maxwell@medstar.net
Inger H Ljungberg, MPH, (202) 877-1694, inger.h.ljungberg@medstar.net
About this study
Official title: Intravesical Lactobacillus rhamnosusGG Versus Saline Bladder Wash: A Randomized, Controlled, Comparative Effectiveness Clinical Trial
This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).
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.
SPECIFIC AIM 1 Compare the effects of Lactobacillus Rhamnosus GG (LGG®) + Saline bladder wash (BW) versus BW alone on USQNB-determined bladder (B1) and urine quality (B2) symptom burden (two co-primary outcomes) where participants self-manage in response to two trigger symptoms (cloudier and/or more foul-smelling urine).
SPECIFIC AIM 2 Compare the effects of LGG®+BW versus BW alone (in response to the two trigger symptoms) on key secondary outcomes: number of days lost from rehabilitation, work, and/or school; number of days symptomatic; number of interactions with the health care system due to urinary symptoms; exposure to antibiotics (days, volume).
SPECIFIC AIM 3 Compare the prophylactic effects of LGG®+BW versus BW alone on USQNB-determined bladder (B1) and urine quality (B2) symptom burden.
SPECIFIC AIM 4 Compare the prophylactic effects of LGG®+BW versus BW alone on key secondary outcomes: number of days lost from rehabilitation, work, and/or school; number of days symptomatic; number of interactions with the health care system due to urinary symptoms; exposure to antibiotics (days, volume).
SPECIFIC AIM 5 Compare satisfaction of participants who instilled LGG®+BW to satisfaction of those who instilled BW only and determine if dropouts are differentially attributable to either intervention being perceived by participants as "not working".
- Conditions
- Spinal Cord Injuries, Neurogenic Bladder
- Being tested
- Lactobacillus RhamnosusGG, Saline bladder wash
- Keywords
- Intermittent Catheter
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus RhamnosusGGDrug
Also called Culturelle Probiotic LGG®
LGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. 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 after the last catheterization prior to going to bed. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time), and then continue completing the USQNB-IC at the determined frequency for the phase.
Saline bladder washDrug
Participants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time), and then continue completing the USQNB-IC at the determined frequency for the phase.
| Study group | Role | What they receive |
|---|---|---|
| Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Treatment Phase) | Experimental | LGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. For the LGG® instillation in response to trigger symptoms, 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 after the last catheterization prior to going to bed. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and daily during instillations for 2 days after the final instillation. Subjects will remain in this phase 6 months. Receives: Drug: Lactobacillus RhamnosusGG |
| Intravesical Bladder Wash (Treatment Phase) | Other | Participants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and daily during instillations for 2 days after the final instillation. Subjects will remain in this phase 6 months. Receives: Drug: Saline bladder wash |
| Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Prophylaxis Phase) | Experimental | LGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. For the LGG® instillation in response to trigger symptoms, 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 after the last catheterization prior to going to bed. They will then instill the LGG® mixture every 2 days for the remainder of the 6 months. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and biweekly post-instillation. Subjects will remain in this phase 6 months. Receives: Drug: Lactobacillus RhamnosusGG |
| Intravesical Bladder Wash (Prophylaxis Phase) | Other | Participants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. They will then instill the saline BW every 2 days for the remainder of the 6 months. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and biweekly post-instillation. Subjects will remain in this phase 6 months. Receives: Drug: Saline bladder wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
International SCI Lower Urinary Tract Function Basic Data Set
A tool that describes urinary tract impairment, awareness of need to empty 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.
Measured: Day 1
International SCI Core Data Set
Includes date of injury, dates of initial hospitalization admission and discharge, neurological data. Score is not associated with outcome.
Measured: Day 1
NINDS Medical History CDE
A brief medical history using body system categories. Score is not associated with outcomes.
Measured: Day 1
NINDS Prior and Concomitant Medications CDE
Contains whether or not the participant is taking a medication during the study protocol, name of the medication, reason for medication, medication dose, frequency, start and end dates, and free text. Score is not associated with outcomes.
Measured: Day 1
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
Measured: (SA1 and SA3) Weekly up to 18 months
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
Measured: (SA1) Day 1 post-instillation (Phase 2: treatment phase)
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
Measured: (SA1) Day 2 post-instillation (Phase 2: treatment phase)
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
Measured: (SA3) Twice weekly post-instillation for up to 6 months (Phase 3: prophylaxis phase)
Patient Satisfaction Survey
We developed a simple three-item patient satisfaction "survey" that will be requested from only those individuals who used the intervention (LGG® +BW or BW only) at the time of final USQNB-IC completion, or at the drop out visit (for those who did use the intervention at least once). Participants will be asked to estimate, using a scale from 0% <totally dissatisfied/would absolutely never do this>, through 50% <neither satisfied nor dissatisfied/might do this> to 100% <completely satisfied/would absolutely always do this>:
- How satisfied with the intervention you used are you?
- Would you seek this intervention out and pay for it if insurance did not pay for it?
- Would you use or recommend the intervention in response to symptoms, prophylactically, or both? :At the drop out visit, we will ask these three questions and one additional item for those who used the intervention at least once, "Are you dropping out because the intervention was not working for you?"
Measured: At final USQNB-IC completion (between 13 to 18 months) or at participant drop-out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start13 Jun 2022
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Randomized, controlled comparative effectiveness clinical trial.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Groah, MD, MSPH, Principal investigator, MedStar National Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230511
- Sponsor's protocol ID
- STUDY00004287
- Status last verified
- Aug 2025
- First submitted
- 28 Jan 2022
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Lactobacillus rhamnosusGG Versus Saline Bladder Wash: A Randomized, Controlled, Comparative Effectiveness Clinical Trial
- ClinicalTrials.gov ID
- NCT05230511
- Acronym / sponsor ID
- STUDY00004287
- Conditions
- Spinal Cord Injuries, Neurogenic Bladder
- Keywords
- Intermittent Catheter
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Feb 2022 (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.
This is the first ever comparative effectiveness study of an antibiotic-sparing novel self-management intervention to prevent complicated urinary tract infection (UTI).
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 Compare the effects of Lactobacillus Rhamnosus GG (LGG®) + Saline bladder wash (BW) versus BW alone on USQNB-determined bladder (B1) and urine quality (B2) symptom burden (two co-primary outcomes) where participants self-manage in response to two trigger symptoms (cloudier and/or more foul-smelling urine).
SPECIFIC AIM 2 Compare the effects of LGG®+BW versus BW alone (in response to the two trigger symptoms) on key secondary outcomes: number of days lost from rehabilitation, work, and/or school; number of days symptomatic; number of interactions with the health care system due to urinary symptoms; exposure to antibiotics (days, volume).
SPECIFIC AIM 3 Compare the prophylactic effects of LGG®+BW versus BW alone on USQNB-determined bladder (B1) and urine quality (B2) symptom burden.
SPECIFIC AIM 4 Compare the prophylactic effects of LGG®+BW versus BW alone on key secondary outcomes: number of days lost from rehabilitation, work, and/or school; number of days symptomatic; number of interactions with the health care system due to urinary symptoms; exposure to antibiotics (days, volume).
SPECIFIC AIM 5 Compare satisfaction of participants who instilled LGG®+BW to satisfaction of those who instilled BW only and determine if dropouts are differentially attributable to either intervention being perceived by participants as "not working".
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized, controlled comparative effectiveness clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Treatment Phase) | Experimental | Drug: Lactobacillus RhamnosusGGLGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. For the LGG® instillation in response to trigger symptoms, 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 after the last catheterization prior to going to bed. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and daily during instillations for 2 days after the final instillation. Subjects will remain in this phase 6 months. |
| Intravesical Bladder Wash (Treatment Phase) | Other | Drug: Saline bladder washParticipants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and daily during instillations for 2 days after the final instillation. Subjects will remain in this phase 6 months. |
| Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Prophylaxis Phase) | Experimental | Drug: Lactobacillus RhamnosusGGLGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. For the LGG® instillation in response to trigger symptoms, 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 after the last catheterization prior to going to bed. They will then instill the LGG® mixture every 2 days for the remainder of the 6 months. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and biweekly post-instillation. Subjects will remain in this phase 6 months. |
| Intravesical Bladder Wash (Prophylaxis Phase) | Other | Drug: Saline bladder washParticipants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. They will then instill the saline BW every 2 days for the remainder of the 6 months. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time) and biweekly post-instillation. Subjects will remain in this phase 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years;
- SCI at least 6 months duration;
- NLUTD (as determined by their SCI physician or urologist);
- Utilizing intermittent catheterization for bladder management; and
- Community dwelling (discharged from the acute care setting).
Key exclusion criteria (9 listed)
- Known genitourinary pathology beyond neuropathic bladder (i.e., vesicoureteral reflux, bladder or kidney stones, etc.);
- Use of prophylactic antibiotics;
- Instillation of intravesical agents (e.g., gentamycin, saline; or Lactobacillus);
- Immunodeficiency;
- Any oral antibiotics within the past 2 weeks;
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 |
|---|---|---|
| Lactobacillus RhamnosusGGAlso: Culturelle Probiotic LGG®LGG® (Culturelle Probiotic LGG®) will be used. This is the product we have used in the past and for which we have demonstrated safety, tolerability, and preliminary efficacy. 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 after the last catheterization prior to going to bed. Participants will be asked to return any remaining capsules at the end of the study. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time), and then continue completing the USQNB-IC at the determined frequency for the phase. | Drug | Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Prophylaxis Phase), Intravesical Lactobacillus RhamnosusGG and Bladder Wash (Treatment Phase) |
| Saline bladder washParticipants will draw up the 45cc of normal saline into a 60cc syringe and instill via the intermittent catheter after the last catheterization prior to going to bed after trigger symptoms occur. Participants will be instructed to complete the USQNB-IC at the time of symptoms (in real time), and then continue completing the USQNB-IC at the determined frequency for the phase. | Drug | Intravesical Bladder Wash (Prophylaxis Phase), Intravesical Bladder Wash (Treatment Phase) |
Primary outcome
International SCI Lower Urinary Tract Function Basic Data Set
Time frame: Day 1
A tool that describes urinary tract impairment, awareness of need to empty 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.
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 outcome.
NINDS Medical History CDE
Time frame: Day 1
A brief medical history using body system categories. Score is not associated with outcomes.
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 the medication, reason for medication, medication dose, frequency, start and end dates, and free text. Score is not associated with outcomes.
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
Time frame: (SA1 and SA3) Weekly up to 18 months
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
Time frame: (SA1) Day 1 post-instillation (Phase 2: treatment phase)
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
Time frame: (SA1) Day 2 post-instillation (Phase 2: treatment phase)
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter
Time frame: (SA3) Twice weekly post-instillation for up to 6 months (Phase 3: prophylaxis phase)
Will measure change in urinary symptoms for those that use an intermittent catheter. Higher scores may mean worse outcomes.
Patient Satisfaction Survey
Time frame: At final USQNB-IC completion (between 13 to 18 months) or at participant drop-out
We developed a simple three-item patient satisfaction "survey" that will be requested from only those individuals who used the intervention (LGG® +BW or BW only) at the time of final USQNB-IC completion, or at the drop out visit (for those who did use the intervention at least once). Participants will be asked to estimate, using a scale from 0% <totally dissatisfied/would absolutely never do this>, through 50% <neither satisfied nor dissatisfied/might do this> to 100% <completely satisfied/would absolutely always do this>: 1. How satisfied with the intervention you used are you? 2. Would you seek this intervention out and pay for it if insurance did not pay for it? 3. Would you use or recommend the intervention in response to symptoms, prophylactically, or both? :At the drop out visit, we will ask these three questions and one additional item for those who used the intervention at least once, "Are you dropping out because the intervention was not working for you?"
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 29 Aug 2025.
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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.
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 Lactobacillus RhamnosusGG and Saline bladder wash in people with Spinal Cord Injuries and 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 9 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: looking for participants now, as of the sponsor's last update on 29 Aug 2025. 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?
Contact Emily Leonard, PhD ((202) 877-1844, emily.m.leonard@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International SCI Lower Urinary Tract Function Basic Data Set (time frame: Day 1). The study lists 9 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 29 Aug 2025.