Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD

20. august 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

48

Fase

  • Tidlig fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20010
        • MedStar National Rehabilitation Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Amanda Garver, DO
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15224
        • University of Pittsburgh Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Catherine Forster, MD, MS

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Andre navn:
  • Lactobacillus RhamnosusGG
Eksperimentell: 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.
Andre navn:
  • Lactobacillus RhamnosusGG

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Level of Lactobacillus rhamnosus GG in Urine
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Length of Recolonization
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Amanda Garver, DO, MedStar National Rehabilitation Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. september 2027

Datoer for studieregistrering

Først innsendt

8. juni 2026

Først innsendt som oppfylte QC-kriteriene

8. juni 2026

Først lagt ut (Faktiske)

12. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere