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

Not yet recruitingEarly phase 1MS (type not specified)NCT07643974

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Gentamicin
  • Lactobacillus Rhamnosus GG

What it measured

Main measures

  • Level of Lactobacillus rhamnosus GG in Urine

    24 hours after final LGG instillation

Other measures (1)

  • Length of Recolonization

    28 days after final Lactobacillus instillation

Who could take part

MS (type not specified) · 18 and over

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Loading reviews and guidelines…

History

    1. Started

      Aug 2026

    2. Main results due

      Sept 2027

    3. Finished

      Sept 2027

    Assembled by software from public sources.