Spinal Cord InjuriesPhase 2NCT04373512

Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury

A Phase 2 study testing Culturelle 10 Billion CFU Capsule (2 doses) and Culturelle 10 Billion CFU Capsule (4 doses) in people with Spinal Cord Injuries and Neurogenic Bladder, run by Medstar Health Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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: Spinal Cord Injuries, Neurogenic Bladder
What is being tested?: Culturelle 10 Billion CFU Capsule (2 doses) and Culturelle 10 Billion CFU Capsule (4 doses)
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: 1 Jun 2020to 14 Feb 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

SCI at least 1-year duration;
Neurogenic bladder;
Utilizing intermittent catheterization for bladder management;
Women must be premenopausal and not currently menstruating;
Community dwelling

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

Other trials in United States

About this study

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

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.

Conditions: Spinal Cord Injuries, Neurogenic Bladder
Being tested: Culturelle 10 Billion CFU Capsule (2 doses), Culturelle 10 Billion CFU Capsule (4 doses)
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.

Culturelle 10 Billion CFU Capsule (2 doses)Drug
Also called Lactobacillus RhamnosusGG
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
Culturelle 10 Billion CFU Capsule (4 doses)Drug
Also called Lactobacillus RhamnosusGG
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

Study groups in NCT04373512
Study group	Role	What they receive
Low Dosage Group	Experimental	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. 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 (2 doses)
High Dosage Group	Experimental	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. 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 (4 doses)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Successful Reduction of Urinary Symptoms
20% reduction in urinary symptoms within 48 hours of completion of intervention
Measured: Participants (low and high group) fill out the USQNB-IC at the onset of their symptoms, and 48 hours after the last dose. Definition of "success" is 20% reduction in number of endorsed symptoms between the first and final USQNB-IC.

Secondary outcomes (5)

Leukocyte Esterase
urinary leukocyte esterase level (ordinal count levels)
Measured: Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 36 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
Change in Cultivable Bacteria Pre and Post LGG Instillations
Standard urine culture (SUC) results based on quantity (colony forming units) and identified organism. (number of organisms cultivated/identified; yes/no if any were cultivated at or greater than 10^5)
Measured: Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 24 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
Change in Urine Nitrite Pre and Post LGG Instillations
Standard urine analysis. Urine derived nitrites (positive or negative)
Measured: Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 24 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
Change in Urine White Blood Cell Count Pre and Post LGG Instillations
urine derived white blood cells per high powered field (ordinal count levels)
Measured: Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 24 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
Change in uNGAL Pre and Post LGG Instillations
urinary neutrophil gelatinase-associated lipocalin in µg/L (continuous)
Measured: Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 24 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202014 Feb 2025

First posted4 May 2020
Study start1 Jun 2020
Primary completion14 Feb 2025
Study completion14 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Design: Prospective, randomized pilot intervention clinical trial. Target Enrollment: 182 subjects total at least 1-year post-SCI. 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 (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04373512
Sponsor's protocol ID: STUDY00001124
Other IDs: CDMRP-eBRAP Log Number
Status last verified: May 2025
First submitted: 1 Nov 2019
Last updated: 3 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury

All Spinal Cord Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury
ClinicalTrials.gov ID: NCT04373512
Acronym / sponsor ID: STUDY00001124
Conditions: Spinal Cord Injuries, Neurogenic Bladder
Keywords: Intermittent Catheter
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 182 participants (actual)
Lead sponsor: Medstar Health Research InstituteUniversity, hospital or other
Collaborators: Children's National Research Institute, Congressionally Directed Medical Research Programs
Study start: 1 Jun 2020 (actual)
Primary completion: 14 Feb 2025 (actual)
Study completion: 14 Feb 2025 (actual)
First posted: 4 May 2020 (actual)
Results: Posted 3 Nov 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

SPECIFIC AIM 1

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 total at least 1-year post-SCI. 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 Group	Experimental	Drug: Culturelle 10 Billion CFU Capsule (2 doses)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. 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 Group	Experimental	Drug: Culturelle 10 Billion CFU Capsule (4 doses)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. 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)

SCI at least 1-year duration;
Neurogenic bladder;
Utilizing intermittent catheterization for bladder management;
Women must be premenopausal and not currently menstruating;
Community dwelling

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 Capsule (2 doses)Also: Lactobacillus RhamnosusGGFor 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	Drug	Low Dosage Group
Culturelle 10 Billion CFU Capsule (4 doses)Also: Lactobacillus RhamnosusGGFor 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	Drug	High Dosage Group

Primary outcome

Number of Participants With Successful Reduction of Urinary Symptoms
Time frame: Participants (low and high group) fill out the USQNB-IC at the onset of their symptoms, and 48 hours after the last dose. Definition of "success" is 20% reduction in number of endorsed symptoms between the first and final USQNB-IC.
20% reduction in urinary symptoms within 48 hours of completion of intervention

5 secondary outcomes

Leukocyte Esterase
Time frame: Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 36 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
Change in Cultivable Bacteria Pre and Post LGG Instillations
Time frame: Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 24 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
Change in Urine Nitrite Pre and Post LGG Instillations
Time frame: Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 24 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
Change in Urine White Blood Cell Count Pre and Post LGG Instillations
Time frame: Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 24 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.
Change in uNGAL Pre and Post LGG Instillations
Time frame: Participants in our two dose groups, low (two doses 24 hours apart) and high (four doses 24 hours apart), give a urine sample at the onset of their symptoms, and then again 48 hours after the last dose.

Results and safety

Results posted to the registry on 3 Nov 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Dosage Group	89	61
High Dosage Group	88	58

Primary outcome: Number of Participants With Successful Reduction of Urinary Symptoms

Time frame: Participants (low and high group) fill out the USQNB-IC at the onset of their symptoms, and 48 hours after the last dose. Definition of "success" is 20% reduction in number of endorsed symptoms between the first and final USQNB-IC.. Count of participants. Unit: Participants

Measure	Low Dosage Group n = 47	High Dosage Group n = 41
Value	30	28

Population analysed: We defined "responders" as those participants who met the 20% reduction in symptoms post-instillation criterion; otherwise, participants who did instill were "non-responders". We calculated responder status for total symptoms (which the study was powered to detect) and also for the two trigger symptoms (cloudier/more foul-smelling urine).

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 years, 7 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dosage Group	5 of 89 (5.6%)	9 of 89 (10.1%)	1 of 89
High Dosage Group	10 of 88 (11.4%)	12 of 88 (13.6%)	2 of 88

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Spinal Cord Injuries

Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury

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?

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: finished, as of the sponsor's last update on 3 Nov 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?

Yes. Results are posted in the registry (first posted 3 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Successful Reduction of Urinary Symptoms (time frame: Participants (low and high group) fill out the USQNB-IC at the onset of their symptoms, and 48 hours after the last dose. Definition of "success" is 20% reduction in number of endorsed symptoms between the first and final USQNB-IC.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04373512.

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 3 Nov 2026.