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.
Neurologic diagnosis
≥18 years old
Neurogenic bladder for at least 6 months
No USQNB-IC A, B1, or B2 symptoms
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
Parallel
Gentamicin
DrugGentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg/mL. 50cc (48 mg) of the resulting solution will be drawn up into a catheter tip syringe, which will then be capped and inserted into sterile packaging. Seven such syringes will be overnight mailed to each participant in temperature-controlled shipping containers, with the extra syringe being included in case of damage or accidental dropping of one of the six instillations. Patients will be instructed to refrigerate all syringes immediately upon receipt. The first instillation will occur after the first catheterization of the morning. Once ready to begin instillations, the full contents of one syringe will then be instilled into the bladder after drainage of urine is complete by catheterization and the solution has reach room temperature; the solution will be left indwelling for at least four hours. This will be done every 12 hours for three days (6 doses).
Lactobacillus Rhamnosus GG
DrugParticipants will be instructed to mix the contents of 1 LGG capsule into 45cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG mixture into a 60 cc syringe and instill the first dose via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 4 or 6 LGG capsules (2 additional capsules/participant, depending on randomization group) and will repeat this process every 12 hours until s/he has completed assigned dosing, according to randomization group. The first LGG instillation will occur 72 hours after the final dose of gentamicin.
Level of Lactobacillus rhamnosus GG in Urine
Urine samples will be analyzed with qPCR to determine whether LGG is present and, if so, at what concentration. Concentration from 24 hours after final LGG instillation will be compared to that measured after final gentamicin instillation. An increase of 30% or greater from baseline will be considered successful recolonization if LGG is present at baseline, otherwise absolute increase will be used.
Length of Recolonization
Urine samples collected at 7 days, 14 days, and 28 days after final Lactobacillus instillation will be analyzed with qPCR to determine if Lactobacillus is present, and if so, at what concentration. These values will be compared with the samples taken after gentamicin instillations and 24 hours after final LGG instillation to determine how long increased LGG values persist.
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Medstar Health Research Institute
Lead sponsor
United States Department of Defense
Collaborator
University of Pittsburgh Medical Center
Collaborator
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