[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643017":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":78,"collaborators":80,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":25,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":25,"enrollmentInfo":94,"targetDuration":25,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":108,"overallStatus":116,"whyStopped":25,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Medstar Health Research Institute","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Low Dose","EXPERIMENTAL","Gentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg\u002FmL. 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. 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; the solution will be left indwelling until the next catheterization. This will be done six times. Low dose participants will wait 72 hours, then mix one capsule LGG into 45mL sterile saline and instill the resulting mixture in the same fashion as the gentamicin. Low dose participants will do this in once in the evening and again 12 hours later (the following morning). This mixture will remain in the bladder for at least 4 hours.",[13,14],"Drug: Gentamicin","Drug: Lactobacillus Rhamnosus GG",{"label":16,"type":10,"description":17,"interventionNames":18},"High Dose","Gentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg\u002FmL. 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. 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; the solution will be left indwelling until the next catheterization. This will be done six times. High dose participants will wait 72 hours, then mix one capsule LGG into 45mL sterile saline and instill the resulting mixture in the same fashion as the gentamicin. High dose participants will do this in once in the evening, and again every 12 hours until four doses are complete. This mixture will remain in the bladder for at least 4 hours.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Gentamicin","Gentamicin will be diluted in normal saline under sterile conditions by qualified pharmacy personnel to a concentration of 0.96mg\u002FmL. 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).",[16,9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Lactobacillus Rhamnosus GG","Participants 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\u002Fparticipant, depending on randomization group) and will repeat this process every 12 hours until s\u002Fhe has completed assigned dosing, according to randomization group. The first LGG instillation will occur 72 hours after the final dose of gentamicin.",[16,9],[31],"Lactobacillus RhamnosusGG",[33],{"name":34,"affiliation":35,"role":36},"Amanda Garver, DO","MedStar National Rehabilitation Hospital","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":25,"email":42},"Christopher R Riegner, MPH","CONTACT","202-877-1000","christopher.r.riegner@medstar.net",{"name":44,"role":40,"phone":41,"phoneExt":25,"email":45},"Inger H Ljungberg, MPH","inger.h.ljungberg@medstar.net",[47,64],{"facility":35,"status":25,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Washington D.C.","District of Columbia","20010","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-77.03637,38.89511,{"lat":57,"lon":56},[60,63],{"name":61,"role":40,"phone":62,"phoneExt":25,"email":42},"Chris Riegner, MPH","2028771000",{"name":34,"role":36,"phone":25,"phoneExt":25,"email":25},{"facility":65,"status":25,"city":66,"state":67,"zip":68,"country":51,"countryCode":52,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"University of Pittsburgh Medical Center","Pittsburgh","Pennsylvania","15224",{"type":54,"coordinates":70},[71,72],-79.99589,40.44062,{"lat":72,"lon":71},[75,76],{"name":61,"role":40,"phone":62,"phoneExt":25,"email":42},{"name":77,"role":36,"phone":25,"phoneExt":25,"email":25},"Catherine Forster, MD, MS",{"type":79,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[81,84],{"name":82,"class":83},"United States Department of Defense","FED",{"name":65,"class":6},"100643017","early-phase-1-coupled-gentamicin-lactobacillus-rhamnosus-in-nlutd-100643017",false,"NCT07643974","Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD","Effect of Dose Timing of Coupled Intravesical Gentamicin and Lactobacillus Rhamnosus LGG on Success and Length of Colonization in Men and Women With SCI\u002FD and NLUTD","Inclusion Criteria:\n\n* Neurologic diagnosis\n* ≥18 years old\n* Neurogenic bladder for at least 6 months\n* No USQNB-IC A, B1, or B2 symptoms\n* No currently diagnosed UTI (within 24 hours of initiating instillations)\n* Community dwelling (not in acute hospital setting)\n\nExclusion Criteria:\n\n* Known genitourinary pathology beyond NLUTD (i.e. kidney stones, bladder stones, vesicoureteral reflux, etc.)\n* Use of prophylactic antibiotics or any antibiotics within 2 weeks of beginning instillations\n* Instillation of intravesical agents other than saline bladder wash\n* Immunodeficiency\n* Psychologic or psychiatric conditions influencing the ability to follow instructions\n* Allergy to ampicillin, daptomycin, gentamicin\u002Fgentamycin, or probiotics\n* Participation in another study which could confound results","ALL","18 Years",{"count":95,"type":96},48,"ESTIMATED","INTERVENTIONAL",[99],"EARLY_PHASE1","The main objective of the proposed research study is to determine in men and women with spinal cord injury\u002Fdisease 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.",[102,103,104,105,106,107],"Spinal Cord Injury","Neurogenic Bladder (NB)","Neurogenic Lower Urinary Tract Dysfunction","Multiple Sclerosis","Spina Bifida","Urinary Tract Infection(UTI)",[109,110,111,112,113,114,115],"gentamicin","gentamycin","lactobacillus","spinal cord injury","spinal cord disease","urinary tract infection","neurogenic bladder","NOT_YET_RECRUITING","2026-06-08",{"date":119,"type":120},"2026-06-12","ACTUAL",{"date":122,"type":96},"2026-06",{"date":124,"type":96},"2027-09",{"name":5,"class":6},2]