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Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD

20 de agosto de 2026 atualizado por: Medstar Health Research Institute

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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

48

Estágio

  • Fase inicial 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20010
        • MedStar National Rehabilitation Hospital
        • Contato:
        • Investigador principal:
          • Amanda Garver, DO
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15224
        • University of Pittsburgh Medical Center
        • Contato:
        • Investigador principal:
          • Catherine Forster, MD, MS

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Low Dose
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, 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).
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.
Outros nomes:
  • Lactobacillus RhamnosusGG
Experimental: High Dose
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.
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).
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.
Outros nomes:
  • Lactobacillus RhamnosusGG

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Level of Lactobacillus rhamnosus GG in Urine
Prazo: 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.
24 hours after final LGG instillation

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Length of Recolonization
Prazo: 28 days after final Lactobacillus instillation
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.
28 days after final Lactobacillus instillation

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Amanda Garver, DO, MedStar National Rehabilitation Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

1 de setembro de 2027

Conclusão do estudo (Estimado)

1 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

8 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de junho de 2026

Primeira postagem (Real)

12 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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