RightFit
Not yet recruitingEarly Phase 1

Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adult men and women with a spinal cord injury or disease and bladder problems caused by nerve damage. It tests whether the dose of gentamicin, an antibiotic, paired with Lactobacillus rhamnosus GG, a helpful bacterium, affects how bacteria grow again in the bladder and whether results differ by sex. It also checks safety and whether the bacteria stay for 7, 14, or 28 days.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a diagnosed condition affecting the brain, spinal cord, or nerves.
  • Be at least 18 years old.
  • Have bladder problems caused by nerve damage for at least 6 months.
  • Have none of the symptoms listed in sections A, B1, or B2 of the USQNB-IC symptom checklist.
  • Have no diagnosed urinary tract infection (UTI) within 24 hours before treatment starts.
  • Live in the community, not in a hospital for short-term care.

Who can't join

  • Have other urinary or genital conditions, such as kidney stones, bladder stones, or urine flowing backward toward the kidneys.
  • Take antibiotics to prevent infection, or have taken any antibiotics within 2 weeks before treatment starts.
  • Put any substance directly into the bladder other than a saltwater bladder rinse.
  • Have a weakened immune system.
  • Have a mental health condition that affects your ability to follow instructions.
  • Are allergic to ampicillin, daptomycin, gentamicin (also spelled gentamycin), or probiotics (helpful bacteria).
  • Take part in another study that could affect this study's results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (2)

DC

PA