[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100398042":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":34,"armGroups":35,"interventions":41,"overallOfficials":30,"centralContacts":30,"locations":44,"responsibleParty":63,"collaborators":30,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":30,"studyType":81,"phases":30,"briefSummary":82,"conditions":83,"keywords":89,"overallStatus":47,"whyStopped":30,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Federico II University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":30},[9,13],{"measure":10,"description":11,"timeFrame":12},"Evaluation of clinical features and disease course of non-IgE mediated food allergies in children","Rate of pts affected by FPIES, FPE, FPIAP, FPIMD; diagnostic delay; disease duration, rate of pts with mono vs poli food allergies; main antigens responsible for the diseases; occurrence of atopic dermatitis before food allergy onset; results of allergy screening tests; occurrence of atopic march","After 72 months from the study start",{"measure":14,"description":15,"timeFrame":12},"Evaluation of clinical features of non-IgE mediated food allergies in children","Dietary management and Nutritional status (weight and height will be combined to report BMI z-score)",[17,21,23,25,27],{"measure":18,"description":19,"timeFrame":20},"Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children","Evaluation of serum levels of Th2, Th1, and Th17 cytokines","through study completion, an average of 2 years",{"measure":18,"description":22,"timeFrame":20},"Evaluation of epigenetic mechanisms",{"measure":18,"description":24,"timeFrame":20},"Evaluation of immune cells phenotype",{"measure":18,"description":26,"timeFrame":20},"Evaluation of mithocondrial metabolism of human lymphocytes",{"measure":28,"description":29,"timeFrame":20},"Evaluation of gut microbiome features in children with Non-IgE-mediated food allergies","Evaluation of gut microbiome structure and function",null,{"allocation":30,"interventionModel":30,"interventionModelDescription":30,"primaryPurpose":30,"observationalModel":32,"timePerspective":33,"maskingInfo":30},"COHORT","PROSPECTIVE","subjects consecutively observed at the Pediatric Allergy Program, at the Department of Translational Medical Science of the University of Naples Federico II, both sex, aged between 0-14 years with suggestive history of food allergy",[36],{"label":37,"type":30,"description":38,"interventionNames":39},"Non IgE-mediated food allergy","Children with non IgE-mediated food allergy",[40],"Other: Non IgE-mediated food allergy",[42],{"type":6,"name":37,"description":30,"armGroupLabels":43,"otherNames":30},[37],[45],{"facility":46,"status":47,"city":48,"state":30,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"University of Naples Federico II","RECRUITING","Naples","80131","Italy","IT",{"type":53,"coordinates":54},"Point",[55,56],14.26811,40.85216,{"lat":56,"lon":55},[59],{"name":60,"role":61,"phone":62,"phoneExt":30,"email":30},"Roberto Berni Canani, MD, PhD","CONTACT","+390817462680",{"type":64,"investigatorFullName":60,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Professor of Pediatrics","100398042","non-immunoglobulin-e-mediated-food-allergies-in-children-100398042",false,"NCT04462978","Non-Immunoglobulin E-mediated Food Allergies in Children","Investigating Clinical Features, Natural Course and Pathophysiology of Non-Immunoglobulin E-mediated Food Allergies in the Pediatric Age","NIGEFA","Inclusion Criteria:\n\n* subjects aged between 0-14 years\n* suggestive history of food allergy\n\nExclusion Criteria:\n\n* age \\>14 years-\n* chronic systemic diseases,\n* malignancy,\n* immunodeficiency,\n* infectious diseases,\n* autoimmune diseases,\n* inflammatory bowel diseases,\n* celiac disease,\n* metabolic and genetic diseases,\n* cystic fibrosis,\n* chronic pulmonary diseases,\n* gastrointestinal, respiratory, urinary tract and\u002For cardiovascular malformations,\n* neurologic and\u002For neuropsychiatric disorders,\n* gastrointestinal tract eosinophilic disorders,\n* use of immunomodulating drugs, steroids, pre-pro-synbiotics, antibiotics in the previous 4 months",true,"ALL","1 Day","14 Years",{"count":79,"type":80},150,"ESTIMATED","OBSERVATIONAL","Non-IgE-mediated gastrointestinal food allergies (non-IgE-GIFA) are an evolving web of clinical conditions characterized by subacute and\u002For chronic symptoms and include food protein-induced enterocolitis syndrome (FPIES), food protein-induced enteropathy (FPE), food protein-induced allergic proctocolitis (FPIAP), and food protein-induced allergic dysmotility disorders (gastroesophageal reflux disease (GERD), colic and constipation) (FPIMD).\n\nDespite the prevalence and clinical impact of these conditions, the pathogenesis as well as the natural history and the best management of these disorders are still poorly defined. These limitations could be responsible for diagnostic delays and errors, and suboptimal clinical management. We aim to evaluate clinical features, natural course and pathophysiology of non-IgE-GIFA in the pediatric age.",[84,85,86,87,88],"Non IgE Mediated Food Allergy","Food Protein-Induced Enteropathy","Food Protein-Induced Proctocolitis","Food Protein-Induced Enterocolitis Syndrome","Food Protein-induced Motility Disorders",[90,91,92,93,94,95,85,86,87,96],"Food allergy","Adverse food reactions","Immune tolerance","Atopy patch test","Atopic march","Oral food challenge","Food protein-induced motility disorders","2026-08-31",{"date":99,"type":100},"2026-09-02","ACTUAL",{"date":102,"type":100},"2017-01-01",{"date":104,"type":80},"2027-12-28",{"name":5,"class":6},1]