Spinal Cord InjuryEarly Phase 1NCT07643974
Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD
A Early Phase 1 study testing Gentamicin and Lactobacillus Rhamnosus GG in people with Spinal Cord Injury and Neurogenic Bladder (NB), run by Medstar Health Research Institute at 2 sites in United States.
Trial summary
The main objective of the proposed research study is to determine in men and women with spinal cord injury/disease and neurogenic bladder whether the dose of coupled gentamicin \& Lactobacillus rhamnosus GG affects the recolonization of the bladder, and whether the rate of success differs by sex. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Neurogenic Bladder (NB), Neurogenic Lower Urinary Tract Dysfunction
- What is being tested?
- Gentamicin and Lactobacillus Rhamnosus GG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2026to Sep 2027
- Phase
- Early Phase 1
- 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
- Neurologic diagnosis
- ≥18 years old
- Neurogenic bladder for at least 6 months
- No USQNB-IC A, B1, or B2 symptoms
- No currently diagnosed UTI (within 24 hours of initiating instillations)
- Community dwelling (not in acute hospital setting)
Who cannot join
- Known genitourinary pathology beyond NLUTD (i.e. kidney stones, bladder stones, vesicoureteral reflux, etc.)
- Use of prophylactic antibiotics or any antibiotics within 2 weeks of beginning instillations
- Instillation of intravesical agents other than saline bladder wash
- Immunodeficiency
- Psychologic or psychiatric conditions influencing the ability to follow instructions
- Allergy to ampicillin, daptomycin, gentamicin/gentamycin, or probiotics
- Participation in another study which could confound results
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224
Chris Riegner, MPH, 2028771000, christopher.r.riegner@medstar.net
Catherine Forster, MD, MS
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
Chris Riegner, MPH, 2028771000, christopher.r.riegner@medstar.net
Amanda Garver, DO
About this study
Official title: Effect of Dose Timing of Coupled Intravesical Gentamicin and Lactobacillus Rhamnosus LGG on Success and Length of Colonization in Men and Women With SCI/D and NLUTD
The main objective of the proposed research study is to determine in men and women with spinal cord injury/disease and neurogenic bladder whether the dose of coupled gentamicin \& Lactobacillus rhamnosus GG affects the recolonization of the bladder, and whether the rate of success differs by sex. Secondary objectives include determining whether that recolonization lasts 7, 14, or 28 days; and safety of the coupled gentamicin \& Lactobacillus instillations.
Read the detailed description
People with spinal cord injury/disease (SCI/D) experience, on average, 2.5 episodes of UTI annually. Since repeated exposures of bacteria to antibiotics leads to multi-drug resistant organisms (MDROs), it is likely that the frequent use of antibiotics for UTI is a driver of the increasing prevalence of infections with MDROs in the SCI/D population. This prevalence of MDROs among people with SCI/D represents a microcosm of the world-wide public health crisis of antibiotic resistance. As stated by the CDC, "antibiotic resistance is one of the biggest public health challenges of our time." In the US alone, 2.8M people annually develop infections with resistant microbes; of whom 35,000 die as a direct result. Infections with resistant organisms are associated with longer hospital lengths of stay, increased mortality, and higher health care costs. With UTI persistently being the leading reason for rehospitalizations among people with SCI/D, infections with resistant organisms represent a contributor to elevated health care costs as well as mortality risk. Additionally, the cost to treat a UTI due to an extended-spectrum beta-lactamase (ESBL) organism is estimated to be 1.5 times greater than treating a non-ESBL pathogen. Thus, not only are people with SCI/D and UTI at greater risk of mortality due to MDROs, they are also likely to have higher costs as a result of UTI. These costs can only be expected to increase, as the rate of antibiotic resistant UTIs increases. Moreover, individuals with SCI/D and NLUTD experience lower urinary tract symptoms (LUTS) frequently, and these may be treated with antibiotics whether they represent UTI or not.
As noted earlier, the standard of care for UTI treatment (systemic antibiotics, guided by standard urine culture (SUC)) is flawed and contributes to overtreatment and antimicrobial resistance. Use of intravesical therapeutics have been a part of clinical practice since the 1960's and intravesical antibiotics have been studied for nearly 30 years; however, use of intravesical antibiotics for UTI is typically only considered as a "last resort" (such as for recurrent UTI). Agents used include gentamicin, tobramycin, colistin, and neomycin/polymyxin. Gentamicin is the most commonly studied intravesical antibiotic and when administered intravesicularly, it has been shown to have little to no systemic absorption, nor nephro- or oto-toxicity (as with intravenous administration). Intravesical gentamicin has been shown to be safe, tolerated, and effective for recurrent UTI in people with NLUTD.
The investigators' team was first to compare the urobiomes of people with SCI/D and NLUTD to those of neurologically intact controls. This work verified the existence of the urobiome, showing that most control female urobiomes are predominated by Lactobacillus and some control male urobiomes contain Lactobacillus, but most do not. The investigators also showed that NLUTD urobiomes are dysbiotic, depleted in beneficial bacteria as most NLUTD females lacked or had reduced Lactobacillus levels, while most NLUTD males lacked the Streptococcus and/or Corynebacterium that was commonly observed in control males. These results support the investigators' hypothesis that NLUTD bladders of most females and at least some males could be colonized by LGG, and that LGG in the urobiome could improve urinary symptoms.
- Conditions
- Spinal Cord Injury, Neurogenic Bladder (NB), Neurogenic Lower Urinary Tract Dysfunction, Multiple Sclerosis, Spina Bifida, Urinary Tract Infection(UTI)
- Being tested
- Gentamicin, Lactobacillus Rhamnosus GG
- Keywords
- gentamicin, gentamycin, lactobacillus, spinal cord injury, spinal cord disease, urinary tract infection, neurogenic bladder
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic, Multiple Sclerosis, Spinal Dysraphism, Urinary Tract Infections, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentamicinDrug
Gentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg/mL. 50cc (48 mg) of the resulting solution will be drawn up into a catheter tip syringe, which will then be capped and inserted into sterile packaging. Seven such syringes will be overnight mailed to each participant in temperature-controlled shipping containers, with the extra syringe being included in case of damage or accidental dropping of one of the six instillations. Patients will be instructed to refrigerate all syringes immediately upon receipt. The first instillation will occur after the first catheterization of the morning. Once ready to begin instillations, the full contents of one syringe will then be instilled into the bladder after drainage of urine is complete by catheterization and the solution has reach room temperature; the solution will be left indwelling for at least four hours. This will be done every 12 hours for three days (6 doses).
Lactobacillus Rhamnosus GGDrug
Also called Lactobacillus RhamnosusGG
Participants will be instructed to mix the contents of 1 LGG capsule into 45cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG mixture into a 60 cc syringe and instill the first dose via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 4 or 6 LGG capsules (2 additional capsules/participant, depending on randomization group) and will repeat this process every 12 hours until s/he has completed assigned dosing, according to randomization group. The first LGG instillation will occur 72 hours after the final dose of gentamicin.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | Gentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg/mL. 50cc (48 mg) of the resulting solution will be drawn up into a catheter tip syringe, which will then be capped and inserted into sterile packaging. Seven such syringes will be overnight mailed to each participant in temperature-controlled shipping containers. Once ready to begin instillations, the full contents of one syringe will then be instilled into the bladder after drainage of urine is complete by catheterization; the solution will be left indwelling until the next catheterization. This will be done six times. Low dose participants will wait 72 hours, then mix one capsule LGG into 45mL sterile saline and instill the resulting mixture in the same fashion as the gentamicin. Low dose participants will do this in once in the evening and again 12 hours later (the following morning). This mixture will remain in the bladder for at least 4 hours. Receives: Drug: Gentamicin; Drug: Lactobacillus Rhamnosus GG |
| High Dose | Experimental | Gentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg/mL. 50cc (48 mg) of the resulting solution will be drawn up into a catheter tip syringe, which will then be capped and inserted into sterile packaging. Seven such syringes will be overnight mailed to each participant in temperature-controlled shipping containers. Once ready to begin instillations, the full contents of one syringe will then be instilled into the bladder after drainage of urine is complete by catheterization; the solution will be left indwelling until the next catheterization. This will be done six times. High dose participants will wait 72 hours, then mix one capsule LGG into 45mL sterile saline and instill the resulting mixture in the same fashion as the gentamicin. High dose participants will do this in once in the evening, and again every 12 hours until four doses are complete. This mixture will remain in the bladder for at least 4 hours. Receives: Drug: Gentamicin; Drug: Lactobacillus Rhamnosus GG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Lactobacillus rhamnosus GG in Urine
Urine samples will be analyzed with qPCR to determine whether LGG is present and, if so, at what concentration. Concentration from 24 hours after final LGG instillation will be compared to that measured after final gentamicin instillation. An increase of 30% or greater from baseline will be considered successful recolonization if LGG is present at baseline, otherwise absolute increase will be used.
Measured: 24 hours after final LGG instillation
Secondary outcomes (1)
Length of Recolonization
Urine samples collected at 7 days, 14 days, and 28 days after final Lactobacillus instillation will be analyzed with qPCR to determine if Lactobacillus is present, and if so, at what concentration. These values will be compared with the samples taken after gentamicin instillations and 24 hours after final LGG instillation to determine how long increased LGG values persist.
Measured: 28 days after final Lactobacillus instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Design: prospective, randomized pilot clinical trial. Target Enrollment: 48 subject total at least 6 months post SCI. Setting: Washington, DC metropolitan area (DC, MD, \& VA) and Pittsburgh area (PA). Controls: each participant will serve as their own control.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, University of Pittsburgh Medical Center
- Responsible party
- Sponsor
- Investigators
- Amanda Garver, DO, Principal investigator, MedStar National Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643974
- Sponsor's protocol ID
- STUDY00009848
- Other IDs
- HT94252410372
- Status last verified
- Aug 2026
- First submitted
- 8 Jun 2026
- Last updated
- 21 Aug 2026
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dose Timing of Coupled Intravesical Gentamicin and Lactobacillus Rhamnosus LGG on Success and Length of Colonization in Men and Women With SCI/D and NLUTD
- ClinicalTrials.gov ID
- NCT07643974
- Acronym / sponsor ID
- STUDY00009848
- Conditions
- Spinal Cord Injury, Neurogenic Bladder (NB), Neurogenic Lower Urinary Tract Dysfunction, Multiple Sclerosis, Spina Bifida, Urinary Tract Infection(UTI)
- Keywords
- gentamicin, gentamycin, lactobacillus, spinal cord injury, spinal cord disease, urinary tract infection, neurogenic bladder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- United States Department of Defense, University of Pittsburgh Medical Center
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 12 Jun 2026 (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 main objective of the proposed research study is to determine in men and women with spinal cord injury/disease and neurogenic bladder whether the dose of coupled gentamicin \& Lactobacillus rhamnosus GG affects the recolonization of the bladder, and whether the rate of success differs by sex. Secondary objectives include determining whether that recolonization lasts 7, 14, or 28 days; and safety of the coupled gentamicin \& Lactobacillus instillations.
Detailed description
People with spinal cord injury/disease (SCI/D) experience, on average, 2.5 episodes of UTI annually. Since repeated exposures of bacteria to antibiotics leads to multi-drug resistant organisms (MDROs), it is likely that the frequent use of antibiotics for UTI is a driver of the increasing prevalence of infections with MDROs in the SCI/D population. This prevalence of MDROs among people with SCI/D represents a microcosm of the world-wide public health crisis of antibiotic resistance. As stated by the CDC, "antibiotic resistance is one of the biggest public health challenges of our time." In the US alone, 2.8M people annually develop infections with resistant microbes; of whom 35,000 die as a direct result. Infections with resistant organisms are associated with longer hospital lengths of stay, increased mortality, and higher health care costs. With UTI persistently being the leading reason for rehospitalizations among people with SCI/D, infections with resistant organisms represent a contributor to elevated health care costs as well as mortality risk. Additionally, the cost to treat a UTI due to an extended-spectrum beta-lactamase (ESBL) organism is estimated to be 1.5 times greater than treating a non-ESBL pathogen. Thus, not only are people with SCI/D and UTI at greater risk of mortality due to MDROs, they are also likely to have higher costs as a result of UTI. These costs can only be expected to increase, as the rate of antibiotic resistant UTIs increases. Moreover, individuals with SCI/D and NLUTD experience lower urinary tract symptoms (LUTS) frequently, and these may be treated with antibiotics whether they represent UTI or not.
As noted earlier, the standard of care for UTI treatment (systemic antibiotics, guided by standard urine culture (SUC)) is flawed and contributes to overtreatment and antimicrobial resistance. Use of intravesical therapeutics have been a part of clinical practice since the 1960's and intravesical antibiotics have been studied for nearly 30 years; however, use of intravesical antibiotics for UTI is typically only considered as a "last resort" (such as for recurrent UTI). Agents used include gentamicin, tobramycin, colistin, and neomycin/polymyxin. Gentamicin is the most commonly studied intravesical antibiotic and when administered intravesicularly, it has been shown to have little to no systemic absorption, nor nephro- or oto-toxicity (as with intravenous administration). Intravesical gentamicin has been shown to be safe, tolerated, and effective for recurrent UTI in people with NLUTD.
The investigators' team was first to compare the urobiomes of people with SCI/D and NLUTD to those of neurologically intact controls. This work verified the existence of the urobiome, showing that most control female urobiomes are predominated by Lactobacillus and some control male urobiomes contain Lactobacillus, but most do not. The investigators also showed that NLUTD urobiomes are dysbiotic, depleted in beneficial bacteria as most NLUTD females lacked or had reduced Lactobacillus levels, while most NLUTD males lacked the Streptococcus and/or Corynebacterium that was commonly observed in control males. These results support the investigators' hypothesis that NLUTD bladders of most females and at least some males could be colonized by LGG, and that LGG in the urobiome could improve urinary symptoms.
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 clinical trial. Target Enrollment: 48 subject total at least 6 months post SCI. Setting: Washington, DC metropolitan area (DC, MD, \& VA) and Pittsburgh area (PA). Controls: each participant will serve as their own control.
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: Gentamicin, Drug: Lactobacillus Rhamnosus GGGentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg/mL. 50cc (48 mg) of the resulting solution will be drawn up into a catheter tip syringe, which will then be capped and inserted into sterile packaging. Seven such syringes will be overnight mailed to each participant in temperature-controlled shipping containers. Once ready to begin instillations, the full contents of one syringe will then be instilled into the bladder after drainage of urine is complete by catheterization; the solution will be left indwelling until the next catheterization. This will be done six times. Low dose participants will wait 72 hours, then mix one capsule LGG into 45mL sterile saline and instill the resulting mixture in the same fashion as the gentamicin. Low dose participants will do this in once in the evening and again 12 hours later (the following morning). This mixture will remain in the bladder for at least 4 hours. |
| High Dose | Experimental | Drug: Gentamicin, Drug: Lactobacillus Rhamnosus GGGentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg/mL. 50cc (48 mg) of the resulting solution will be drawn up into a catheter tip syringe, which will then be capped and inserted into sterile packaging. Seven such syringes will be overnight mailed to each participant in temperature-controlled shipping containers. Once ready to begin instillations, the full contents of one syringe will then be instilled into the bladder after drainage of urine is complete by catheterization; the solution will be left indwelling until the next catheterization. This will be done six times. High dose participants will wait 72 hours, then mix one capsule LGG into 45mL sterile saline and instill the resulting mixture in the same fashion as the gentamicin. High dose participants will do this in once in the evening, and again every 12 hours until four doses are complete. This mixture will remain in the bladder for at least 4 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Neurologic diagnosis
- ≥18 years old
- Neurogenic bladder for at least 6 months
- No USQNB-IC A, B1, or B2 symptoms
- No currently diagnosed UTI (within 24 hours of initiating instillations)
Key exclusion criteria (7 listed)
- Known genitourinary pathology beyond NLUTD (i.e. kidney stones, bladder stones, vesicoureteral reflux, etc.)
- Use of prophylactic antibiotics or any antibiotics within 2 weeks of beginning instillations
- Instillation of intravesical agents other than saline bladder wash
- Immunodeficiency
- Psychologic or psychiatric conditions influencing the ability to follow instructions
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 |
|---|---|---|
| GentamicinGentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg/mL. 50cc (48 mg) of the resulting solution will be drawn up into a catheter tip syringe, which will then be capped and inserted into sterile packaging. Seven such syringes will be overnight mailed to each participant in temperature-controlled shipping containers, with the extra syringe being included in case of damage or accidental dropping of one of the six instillations. Patients will be instructed to refrigerate all syringes immediately upon receipt. The first instillation will occur after the first catheterization of the morning. Once ready to begin instillations, the full contents of one syringe will then be instilled into the bladder after drainage of urine is complete by catheterization and the solution has reach room temperature; the solution will be left indwelling for at least four hours. This will be done every 12 hours for three days (6 doses). | Drug | High Dose, Low Dose |
| Lactobacillus Rhamnosus GGAlso: Lactobacillus RhamnosusGGParticipants will be instructed to mix the contents of 1 LGG capsule into 45cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG mixture into a 60 cc syringe and instill the first dose via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 4 or 6 LGG capsules (2 additional capsules/participant, depending on randomization group) and will repeat this process every 12 hours until s/he has completed assigned dosing, according to randomization group. The first LGG instillation will occur 72 hours after the final dose of gentamicin. | Drug | High Dose, Low Dose |
Primary outcome
Level of Lactobacillus rhamnosus GG in Urine
Time frame: 24 hours after final LGG instillation
Urine samples will be analyzed with qPCR to determine whether LGG is present and, if so, at what concentration. Concentration from 24 hours after final LGG instillation will be compared to that measured after final gentamicin instillation. An increase of 30% or greater from baseline will be considered successful recolonization if LGG is present at baseline, otherwise absolute increase will be used.
1 secondary outcome
Length of Recolonization
Time frame: 28 days after final Lactobacillus instillation
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.
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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.
Amanda Garver, DO principal investigator
MedStar National Rehabilitation Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gentamicin and Lactobacillus Rhamnosus GG in people with Spinal Cord Injury and Neurogenic Bladder (NB), run by Medstar Health Research Institute at 2 sites 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 6 inclusion and 7 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: opening soon, 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 2 sites 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Christopher R Riegner, MPH (202-877-1000, christopher.r.riegner@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Lactobacillus rhamnosus GG in Urine (time frame: 24 hours after final LGG instillation). 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.