Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD
Starting soon · Early Phase 1
Conditions studied: Spinal Cord Injury, Neurogenic Bladder (NB), Neurogenic Lower Urinary Tract Dysfunction, Multiple Sclerosis, Spina Bifida, Urinary Tract Infection(UTI)
In brief
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.
Key facts
- Study ID
- NCT07643974
- Run by
- Medstar Health Research Institute
- People needed
- 48
- Starts
- 2026-06-01
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-07-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- MedStar National Rehabilitation Hospital — Washington D.C., District of Columbia, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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