[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100387361":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":42,"responsibleParty":66,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":36,"eligibilityCriteria":76,"healthyVolunteers":73,"sex":77,"minAge":78,"maxAge":36,"enrollmentInfo":79,"targetDuration":36,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":44,"whyStopped":36,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Medstar Health Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Low Dosage","ACTIVE_COMPARATOR","For the LGG® instillation, participants will be instructed to mix the contents of 1 LGG capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG mixture into a 60cc syringe and instill via the indwelling catheter (the catheter will not be changed as this would represent 2 interventions). Participants will be instructed the plug their catheter for 1 hour. Participants will receive 2 \\]LGG capsules and will repeat this process the following day (\"Low\" dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (2 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining kits (including LGG®). Participants will be instructed to complete the USQNB-IDC weekly until study completion.",[13],"Drug: Culturelle 10 Billion CFU Capsule",{"label":15,"type":10,"description":16,"interventionNames":17},"High dosage","For the LGG® instillation, participants will be instructed to mix the contents of 1 LGG capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG mixture into a 60cc syringe and instill via the indwelling catheter (the catheter will not be changed as this would represent 2 interventions). Participants will be instructed the plug their catheter for 1 hour. Participants will receive 4 LGG capsules and will repeat this process the following day twice for a total of four doses (\"High\" dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (4 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining kits (including LGG®). Participants will be instructed to complete the USQNB-IDC weekly until study completion.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Culturelle 10 Billion CFU Capsule","LGG® (Culturelle Probiotic with Lactobacillus RhamnosusGG, shown to produce the largest amount of antibacterial substances against pathogenic bacteria) will be used. For the LGG® instillation, participants will be instructed to mix the contents of 1 LGG capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG mixture into a 60cc syringe and instill via the indwelling catheter (the catheter will not be changed as this would represent 2 interventions). Participants will be instructed the plug their catheter for 1 hour. Participants will receive 2 or 4 LGG capsules (depending on randomization group) and will repeat this process the following day (\"Low\" dose) or twice daily for a total of four doses (\"High\" dose) according to randomization group.",[15,9],[25],"Lactobacillus Rhamnosus GG",[27],{"name":28,"affiliation":29,"role":30},"Suzanne Groah, MD, MSPH","MedStar National Rehabilitation Hospital","PRINCIPAL_INVESTIGATOR",[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Amanda K Rounds, PhD","CONTACT","202-877-1591",null,"Amanda.K.Rounds@medstar.net",{"name":39,"role":34,"phone":40,"phoneExt":36,"email":41},"Inger H Ljungberg","202-877-1694","Inger.H.Ljungberg@medstar.net",[43],{"facility":29,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Washington D.C.","District of Columbia","20010","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-77.03637,38.89511,{"lat":54,"lon":53},[57,60,64],{"name":58,"role":34,"phone":35,"phoneExt":36,"email":59},"Amanda Rounds, PhD","amanda.k.rounds@medstar.net",{"name":61,"role":34,"phone":62,"phoneExt":36,"email":63},"Inger Ljungberg, MPH","202 877-1694","inger.h.ljungberg@medstar.net",{"name":65,"role":30,"phone":36,"phoneExt":36,"email":36},"Suzanne Groah, MD,MSPH",{"type":67,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[69],{"name":70,"class":6},"Children's National Research Institute","100387361","phase-2-intravesical-lactobacillus-for-urinary-symptoms-among-people-with-nlutd-who-use-indwelling-catheters-100387361",false,"NCT04323735","Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters","Inclusion Criteria:\n\n* Neurogenic bladder for at least 6 months;\n* Utilizing indwelling catheterization for bladder management;\n* Women must be premenopausal and not currently menstruating;\n* Community dwelling\n* physical disability\n\nExclusion Criteria:\n\n* Use of prophylactic antibiotics;\n* Instillation of intravesical antimicrobials to prevent UTI;\n* Psychologic or psychiatric conditions influencing the ability to follow instructions;\n* Use of oral or IV antibiotics within the past 2 weeks;\n* Sexual activity within the previous 72 hours;\n* Participation in another study with which results could be confounded.","ALL","18 Years",{"count":80,"type":81},182,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical Lactobacillus RhamnosusGG (LGG®) dose to be used to reduce urinary symptoms in a future clinical trial.",[87],"Neurogenic Bladder",[89,90,91],"Indwelling catheter","Foley catheter","Suprapubic Catheter","2025-10-20",{"date":94,"type":95},"2025-10-22","ACTUAL",{"date":97,"type":95},"2020-01-10",{"date":99,"type":81},"2026-09",{"name":5,"class":6},1]