[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593746":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":37,"centralContacts":54,"locations":60,"responsibleParty":78,"collaborators":37,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":37,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":37,"overallStatus":63,"whyStopped":37,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Niguarda Hospital","OTHER",[8,13,18,23,28],{"label":9,"type":6,"description":10,"interventionNames":11},"Naïve","Subjects at the seizure onset (Naïve)",[12],"Other: Naïve: epilepsy first diagnosis,",{"label":14,"type":6,"description":15,"interventionNames":16},"DRE-surgery","DRE undergoing resective surgery (DRE-surgery)",[17],"Other: DRE-surgery: resective surgery;",{"label":19,"type":6,"description":20,"interventionNames":21},"DRE-VNS","DRE undergoing vagal nerve stimulation (DRE-VNS)",[22],"Other: DRE-VNS: vagal nerve stimulation;",{"label":24,"type":6,"description":25,"interventionNames":26},"DRE-KD","DRE on diet therapy (Ketogenic diet).",[27],"Other: DRE-KD: ketogenic diet.",{"label":29,"type":6,"description":29,"interventionNames":30},"anti-epileptic drugs;",[31],"Drug: anti-epileptic drugs;",[33,38,42,46,50],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Naïve: epilepsy first diagnosis,","no intervention",[9],null,{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"DRE-surgery: resective surgery;","resective surgery",[14],{"type":43,"name":29,"description":44,"armGroupLabels":45,"otherNames":37},"DRUG","Anti-epileptic drugs,",[29],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":37},"DRE-VNS: vagal nerve stimulation;","vagal nerve stimulation",[19],{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":37},"DRE-KD: ketogenic diet.","ketogenic diet.",[24],[55],{"name":56,"role":57,"phone":58,"phoneExt":37,"email":59},"Aglaia Vignoli, Prof, MD","CONTACT","+390264448408","aglaia.vignoli@ospedaleniguarda.it",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"ASST GOM Niguarda","RECRUITING","Milan","Lombardy","20162","Italy","IT",{"type":70,"coordinates":71},"Point",[72,73],9.18951,45.46427,{"lat":73,"lon":72},[76],{"name":77,"role":57,"phone":58,"phoneExt":37,"email":59},"Aglaia Vignoli, Prof., MD",{"type":79,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100593746","microbiota-gut-brain-axis-in-resistant-epilepsy-100593746",false,"NCT07010445","MiCrobiota-gut-brain Axis in Resistant Epilepsy","CARE","Inclusion criteria:\n\n* 3-50 years old;\n* diagnosis of epilepsy at onset or DRE;\n* ensured participation of the patient or a caregiver;\n* willingness to sign the informed consent.\n\nExclusion criteria:\n\n* diagnosis of organic gastrointestinal disorders (e.g. chronic inflammatory bowel disease);\n* special diets;\n* use of antibiotics, corticoids or probiotics in the previous month.","ALL","3 Years","50 Years",{"count":91,"type":92},120,"ESTIMATED","INTERVENTIONAL",[95],"NA","Epilepsy is one of the most common neurological chronic conditions with a serious burden on patients, their caregivers, and society. Drug-resistant epilepsy (DRE) heightens this burden. New approaches are thus a priority. Studies in animal models and humans have shown the link between gut microbiota (GM) and the central nervous system in health, neurological conditions, and neurodevelopmental disorders. DRE has been linked to GM dysbiosis. Preliminary findings in children with DRE showed GM modifications when responding to a ketogenic diet. The mediator role of GM has not yet been studied in DRE patients undergoing surgery\u002Fvagal nerve stimulation.\n\nCARE's central hypothesis is that the GM and its metabolic profile could contribute to clinical outcomes following these different therapeutic procedures. Identifying microbial biomarkers will enable us to deepen the knowledge of the role of gut-brain axis in epilepsy and to tailor the intervention to each patient based on GM modulation.",[98,99,100],"Gut Microbiota","Epilepsy","Drug-Resistant Epilepsy","2026-04-06",{"date":103,"type":104},"2026-04-09","ACTUAL",{"date":106,"type":104},"2024-08-16",{"date":108,"type":92},"2027-02",{"name":5,"class":6},1]