Gentamicin + Lactobacillus for Neurogenic Bladder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for neurogenic bladder in individuals with spinal cord injuries or diseases. It tests whether combining gentamicin, an antibiotic, with the probiotic Lactobacillus can help the bladder restore healthy bacteria and determine the duration of this effect. Participants will receive one of two different doses to assess which is more effective and whether responses differ between men and women. Ideal candidates for this trial have had a neurogenic bladder for at least six months and are not currently experiencing a urinary tract infection. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.
Will I have to stop taking my current medications?
The trial requires that you stop taking any antibiotics at least 2 weeks before starting the study. If you are on prophylactic antibiotics, you will need to discontinue them.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using gentamicin in bladder treatments is generally safe for people with neurogenic bladder. One study found that gentamicin can reduce urinary tract infections without causing major side effects. Similarly, Lactobacillus rhamnosus GG, a type of probiotic, is safe and well-tolerated when placed directly in the bladder, helping to maintain a balanced and healthy bacterial environment.
This trial is in an early stage, so detailed safety information about using these treatments together might be limited. However, past studies suggest that each treatment is safe on its own. Participants in this trial will contribute to gathering more specific information about the safety of using these treatments together.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the Gentamicin + Lactobacillus treatment for neurogenic bladder because it introduces a new approach using a combination of an antibiotic and a probiotic. Unlike typical treatments that often focus solely on catheterization or anticholinergic medications to manage symptoms, this approach targets bladder infections directly by using gentamicin to combat bacteria and Lactobacillus to restore healthy bladder flora. The two treatment arms, low dose and high dose, offer a unique delivery method where the solution is instilled directly into the bladder, potentially providing more targeted and effective results. This combination could offer a more comprehensive treatment option by not only addressing infection but also promoting a healthier bladder environment.
What evidence suggests that this trial's treatments could be effective for neurogenic bladder?
This trial will evaluate the effects of combining gentamicin and Lactobacillus rhamnosus GG for neurogenic bladder. Research has shown that applying gentamicin directly in the bladder can reduce urinary tract infections (UTIs) in individuals with nerve-related bladder issues, such as those with spinal cord injuries. Studies also indicate that the probiotic Lactobacillus rhamnosus GG can improve urine quality and lessen symptoms. Participants in this trial will receive either a low or high dose of this combination, aiming to restore healthy bacteria in the bladder and decrease infections. Early results suggest this combination could be a promising approach.12346
Who Is on the Research Team?
Amanda Garver, DO
Principal Investigator
MedStar National Rehabilitation Hospital
Are You a Good Fit for This Trial?
This trial is for men and women with spinal cord injury or diseases like multiple sclerosis, spina bifida, or cervical disc disorder who have bladder problems such as neurogenic bladder or frequent urinary tract infections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravesical gentamicin and Lactobacillus rhamnosus GG instillations
Follow-up
Participants are monitored for the presence and concentration of Lactobacillus rhamnosus GG in urine
What Are the Treatments Tested in This Trial?
Interventions
- Gentamicin
- Lactobacillus Rhamnosus GG
Trial Overview
The study tests if giving a combination of gentamicin (an antibiotic) and Lactobacillus rhamnosus GG (a probiotic) directly into the bladder helps healthy bacteria grow back. It also looks at how long this effect lasts and whether results differ between men and women.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medstar Health Research Institute
Lead Sponsor
United States Department of Defense
Collaborator
University of Pittsburgh Medical Center
Collaborator
Citations
Intravesical Lactobacillus rhamnosus GG versus Saline ... - PMC
Comparative effectiveness trial of self-administered LGG versus saline bladder wash among 120 participants with SCI+NLUTD at least 6 months post SCI. The study ...
Gentamicin + Lactobacillus for Neurogenic Bladder
The study tests if giving a combination of gentamicin (an antibiotic) and Lactobacillus rhamnosus GG (a probiotic) directly into the bladder ...
3.
trial.medpath.com
trial.medpath.com/clinical-trial/43cad9a8e8f11c12/nct07643974-intravesical-gentamicin-lactobacillus-rhamnosus-lgg-sci-nlutdCoupled Gentamicin-Lactobacillus Rhamnosus...
The main objective of the proposed research study is to determine in men and women with spinal cord injury/disease and neurogenic bladder ...
Intravesical Gentamycin Coupled with Lactobacillus ...
Background/Readiness: Urinary tract infection (UTI) is the most common outpatient infection world-wide, and for people with spinal cord ...
5.
semanticscholar.org
semanticscholar.org/paper/Gentamicin-bladder-instillations-decrease-urinary-Cox-He/095401da9db7796b54402345e982b303b0b169b4Gentamicin bladder instillations decrease symptomatic ...
Gentamicin bladder instillations decrease symptomatic urinary tract infections in neurogenic bladder patients on intermittent catheterization.
Lactobacillus rhamnosus GG : A Review of Clinical Use ...
LGG was shown to be of benefit in the reduction of risk of developing attention-deficit hyperactivity disorder and gestational diabetes mellitus.
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