[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550560":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":37,"studyPopulation":33,"armGroups":38,"interventions":46,"overallOfficials":56,"centralContacts":60,"locations":65,"responsibleParty":82,"collaborators":85,"id":91,"slug":33,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":33,"studyType":104,"phases":105,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":67,"whyStopped":33,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"University of Milan","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Epilepsy","to evaluate the number of CDD patients considered treatment responders (seizure reduction ≥50%, ≥75% or ≥100% from baseline in monthly seizure counts) during the 12- week treatment period in 1st and 2nd round of supplementation","Change at 3 months from baseline of each round of supplementation",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Gut microbiota","to evaluate indicator species that could help as biomarkers for guiding clinicians to choose the intervention with the most likelihood of improve patient quality of life.",{"measure":18,"description":19,"timeFrame":12},"Sleep disturbances","Decreased Sleep SDSC scale (max score=125) by at least 5%",{"measure":21,"description":22,"timeFrame":12},"gastrointestinal discomfort","Decrease GISI scale (max score = 17), by at least 2 points",[24,27],{"measure":25,"description":26,"timeFrame":12},"Clinical features","Clinical Global Impression of Change (CGIC), ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating no change\\] decrease of at least 1 point",{"measure":28,"description":29,"timeFrame":12},"Parental stress","Caregiver burden by Parenting Stress Index (PSI-SF); clinically significance \\> 85%, decrease by at least 5%",{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":33,"timePerspective":33,"maskingInfo":35},"NA","SEQUENTIAL",null,"TREATMENT",{"masking":36,"maskingDescription":33,"whoMasked":33},"NONE","CDD is a neurodevelopmental condition characterized by infantile-onset epilepsy, developmental delays, intellectual and motor disabilities, sleep disturbances, and cortical visual impairment. Currently, there is no treatment for CDD, and epilepsy is a prominent and severe feature of the disorder. Standard anti-seizure medications have limited efficacy in seizure control, leading to detrimental effects on cognitive and motor development in CDD.\n\nThe gut-brain axis has gained attention in epilepsy research, prompted by evidence of gastrointestinal (GI) symptoms in people with epilepsy. Studies have demonstrated significant changes in gut microbial composition in animal models and between individuals with epilepsy and healthy subjects. Notably, CDD patients experience GI problems, and we discovered that they exhibit alterations in their gut microbiota compared to healthy individuals. The study will investigate whether supplementing CDD patients with alpha-lactalbum and prebiotics alone or with post-biotics can improve neurological features and modulate microbiota composition.",[39],{"label":40,"type":41,"description":42,"interventionNames":43},"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.",[44,45],"Dietary Supplement: alpha-lactalbumin, fructooligosaccharides, inulin","Dietary Supplement: alpha-lactalbumin, sodium butyrate, fructooligosaccharides, inulin",[47,52],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":33},"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.",[40],{"type":48,"name":53,"description":54,"armGroupLabels":55,"otherNames":33},"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.",[40],[57],{"name":58,"affiliation":5,"role":59},"Aglaia Vignoli, MD","PRINCIPAL_INVESTIGATOR",[61],{"name":58,"role":62,"phone":63,"phoneExt":33,"email":64},"CONTACT","+390264443960","aglaia.vignoli@unimi.it",[66],{"facility":5,"status":67,"city":68,"state":33,"zip":33,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"RECRUITING","Milan","Italy","IT",{"type":72,"coordinates":73},"Point",[74,75],9.18951,45.46427,{"lat":75,"lon":74},[78,79],{"name":58,"role":62,"phone":63,"phoneExt":33,"email":64},{"name":80,"role":81,"phone":33,"phoneExt":33,"email":33},"Elisa Borghi, PhD","SUB_INVESTIGATOR",{"type":59,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Aglaia Vignoli","Professor",[86,88],{"name":87,"class":6},"Fondazione Telethon",{"name":89,"class":90},"Kolfarma s.r.l. - Italy","UNKNOWN","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":102,"type":103},20,"ESTIMATED","INTERVENTIONAL",[31],"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.",[108],"CDKL5",[110],"epilepsy, gut microbiota, sleep disorders","2024-06-03",{"date":113,"type":114},"2024-06-07","ACTUAL",{"date":116,"type":114},"2024-04-01",{"date":118,"type":103},"2025-04-30",{"name":5,"class":6},1]