[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550560":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":35,"responsibleParty":52,"collaborators":55,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":21,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":37,"whyStopped":21,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of Milan","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CDD arm","EXPERIMENTAL","This is a 32-week pilot, single site, cross-over trial of alpha-lactalbumin+ inulin + fructo-oligosaccharides vs alpha-lactalbumin + sodium butyrate + inulin + fructo-oligosaccharides. Periods I and II of the study are 12-week long together with a 4-week washout period.",[13,14],"Dietary Supplement: alpha-lactalbumin, fructooligosaccharides, inulin","Dietary Supplement: alpha-lactalbumin, sodium butyrate, fructooligosaccharides, inulin",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DIETARY_SUPPLEMENT","alpha-lactalbumin, fructooligosaccharides, inulin","The first round supplementation will be administered for 3-month period (i.e. 12 weeks). One dose\u002Fday (2g sachet) is intended to be administered orally once a day after dissolving in water.\n\nAt the scheduled visits\u002Fphone contacts \\[i.e., baseline, 12 weeks, and 16 weeks (post washout)\\], seizure frequency and entity of the critical episodes will be recorded. Gut microbiome characterization, clinical scales and dietary intake will be assessed.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"alpha-lactalbumin, sodium butyrate, fructooligosaccharides, inulin","The second round supplementation will be administered for 3-month period (i.e. 12 weeks). For participants weighing \\\u003C30 kg, a 4 g dose (i.e., one 4 g sachet) is intended to be administered orally once a day after dissolving in water. For participants weighing ≥30 kg, a 4 g dose (i.e., 4 g sachets) is intended to be administered orally twice a day (12h interval) after dissolving in water.\n\nAt the scheduled visits\u002Fphone contacts \\[i.e., 28 weeks and 32 weeks (post washout)\\], seizure frequency and entity of the critical episodes will be recorded. Gut microbiome characterization, clinical scales and dietary intake will be assessed.",[9],[27],{"name":28,"affiliation":5,"role":29},"Aglaia Vignoli, MD","PRINCIPAL_INVESTIGATOR",[31],{"name":28,"role":32,"phone":33,"phoneExt":21,"email":34},"CONTACT","+390264443960","aglaia.vignoli@unimi.it",[36],{"facility":5,"status":37,"city":38,"state":21,"zip":21,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Milan","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],9.18951,45.46427,{"lat":45,"lon":44},[48,49],{"name":28,"role":32,"phone":33,"phoneExt":21,"email":34},{"name":50,"role":51,"phone":21,"phoneExt":21,"email":21},"Elisa Borghi, PhD","SUB_INVESTIGATOR",{"type":29,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Aglaia Vignoli","Professor",[56,58],{"name":57,"class":6},"Fondazione Telethon",{"name":59,"class":60},"Kolfarma s.r.l. - Italy","UNKNOWN","100550560","targeting-the-gut-to-improve-seizure-control-in-cdkl5-deficiency-disorder-cdd-100550560",false,"NCT06448663","Targeting the Gut to Improve Seizure Control in CDKL5 Deficiency Disorder (CDD)","Targeting the Gut to Improve Seizure Control in CDD","NUTRIENT","Inclusion Criteria:\n\nclinical diagnosis of CDD and demonstrated CDKL5 pathogenic variant; drug-resistant seizures; ensured participation of a caregiver; willingness to sign the informed consent.\n\nExclusion Criteria:\n\norganic GI disorders (i.e., food allergies, celiac disease); special diets; percutaneous endoscopic gastrostomy tube; use of antibiotics or probiotics in the previous month.","ALL","3 Years","50 Years",{"count":73,"type":74},20,"ESTIMATED","INTERVENTIONAL",[77],"NA","Standard anti-seizure medications have limited efficacy in seizure control in cyclin-dependent kinase-like 5 deficiency disorder (CDD).\n\nThe study will investigate whether targeting the gut-microbiota-brain axis in CDD patients can alleviate seizures and ameliorate other comorbidities.",[80],"CDKL5",[82],"epilepsy, gut microbiota, sleep disorders","2024-06-03",{"date":85,"type":86},"2024-06-07","ACTUAL",{"date":88,"type":86},"2024-04-01",{"date":90,"type":74},"2025-04-30",{"name":5,"class":6},1]