Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedstar Health Research Institute

About this trial

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 criteria

Qualifiers

Neurologic diagnosis

≥18 years old

Neurogenic bladder for at least 6 months

No USQNB-IC A, B1, or B2 symptoms

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Gentamicin
  • Lactobacillus Rhamnosus GG

Treatment groups

48 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Medstar Health Research Institute

Lead sponsor

United States Department of Defense

Collaborator

University of Pittsburgh Medical Center

Collaborator