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Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD

Not Yet RecruitingEARLY_Phase 1

Sponsor: Medstar Health Research Institute

Conditions: Spinal Cord Injury, Neurogenic Bladder (NB), Neurogenic Lower Urinary Tract Dysfunction, Multiple Sclerosis, Spina Bifida

Interventions: Gentamicin, Lactobacillus Rhamnosus GG

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (2)

Washington D.C., District of Columbia, United States
Pittsburgh, Pennsylvania, United States