Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD

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

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: EARLY_PHASE1

Enrollment: 48

Sponsor: Medstar Health Research Institute

Location: MedStar National Rehabilitation Hospital Washington D.C. District of Columbia

Summary

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

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07643974). StuddyBuddy aggregates publicly available trial information.