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NCT07643974

Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD

Not Yet Recruiting
EARLY_PHASE1Ages 18+InterventionalPrevention
Medstar Health Research Institute
~48 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:GentamicinLactobacillus Rhamnosus GG

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Level of Lactobacillus rhamnosus GG in Urine
Measured over 24 hours after final LGG instillation

Conditions

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

Explore related trials

Multiple SclerosisNeurogenic BladderNeurogenic Lower Urinary Tract DysfunctionSpina BifidaSpinal Cord Injury

Where it's being run

2 sites across 2 states
District of Columbia1
Pennsylvania1

Study leadership

  • Amanda Garver, DO · PRINCIPAL_INVESTIGATOR · MedStar National Rehabilitation Hospital

Who to contact

Christopher R Riegner, MPH
[email protected]
202-877-1000
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Level of Lactobacillus rhamnosus GG in Urine24 hours after final LGG instillation

    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.