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Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD

StatusNot Yet Recruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Start date: Jun 2026 to Aug 2026v3
  2. Study description expanded, about 3 wordsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07643974
Lead Sponsor Medstar Health Research Institute
Collaborators: United States Department of Defense, University of Pittsburgh Medical Center
Conditions
(from sponsor)		 Spinal Cord Injury, Neurogenic Bladder (NB), Neurogenic Lower Urinary Tract Dysfunction, Multiple Sclerosis, Spina Bifida, Urinary Tract Infection(UTI)
Related terms Multiple Sclerosis, Spinal Cord Diseases, Spinal Cord Injuries, Spinal Dysraphism, Urinary Bladder, Neurogenic, Urinary Tract Infections
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov