[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"food-protein-induced-enterocolitis-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:food-protein-induced-enterocolitis-syndrome":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"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":22,"type":23},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.",[27,28,29,30,31],"Non IgE Mediated Food Allergy","Food Protein-Induced Enteropathy","Food Protein-Induced Proctocolitis","Food Protein-Induced Enterocolitis Syndrome","Food Protein-induced Motility Disorders",[33,34,35,36,37,38,28,29,30,39],"Food allergy","Adverse food reactions","Immune tolerance","Atopy patch test","Atopic march","Oral food challenge","Food protein-induced motility disorders","RECRUITING","2026-08-31",{"date":43,"type":44},"2026-09-02","ACTUAL",{"date":46,"type":44},"2017-01-01",{"date":48,"type":23},"2027-12-28",{"name":50,"class":51},"Federico II University","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":18,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":5},"100568614","immunologic-basis-of-food-protein-induced-enterocolitis-syndrome-100568614","NCT06683521","Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome","INFINITY","Inclusion Criteria:\n\n* Provision of appropriate consent and\u002For assent\n* Age 1-60 years\n* Suspected or confirmed FPIES diagnosis\n* Reported convincing FPIES reaction (per criteria in 2017 FPIES guidelines) within: (Children \\\u003C18 years of age: The past 6-36 months) (Adults age \\>18 years: The past 6 months-10 years)\n* Individuals of childbearing potential practicing sexual abstinence or using effective methods of contraception during study participation\n* English-speaking\n\nExclusion Criteria:\n\n* Past severe FPIES defined as hospitalization due to an acute FPIES reaction with neurological compromise or requiring life support\n* Acute FPIES reaction in the past 6 months\n* Frequent gastrointestinal symptoms: nausea, abdominal pain, reflux, heartburn, emesis, diarrhea, constipation per participant or guardian report or as evidenced by FPIES Symptoms Score (FPIES-SS)\n* Current active eosinophilic gastrointestinal disorders, inflammatory bowel disease, gastroesophageal reflux disease, or any other chronic gastrointestinal condition\n* Poorly controlled atopic dermatitis at screening per PI discretion\n* Poorly controlled or severe asthma\u002Fwheezing at screening, defined by at least one of the following criteria: 1: History of two or more systemic corticosteroid courses within six months of screening or one course of systemic corticosteroids within three months of screening to treat asthma\u002Fwheezing; 2: Prior intubation\u002Fmechanical ventilation for asthma\u002Fwheezing; 3: One hospitalization or ED visit for asthma\u002Fwheezing within six months of screening; and 4: Inhaled corticosteroid (ICS) dosing of \\>500 mcg daily fluticasone (or equivalent ICS based on National Heart, Lung, and Blood Institute (NHLBI) dosing chart).\n* IgE-mediated food allergies where the trigger has not been identified\n* Inability to discontinue prohibited medications for 7 days prior to the screening visit and lasting for the duration of study participation unless indicated for use as rescue medication\n* Personal or family history of prolonged QT syndrome\n* Personal history of arrhythmia\n* Current diagnosis of arterial hypertension\n* Current diagnosis of cardiovascular disease\n* Current diagnosis of any chronic autoimmune disease\n* Current diagnosis of liver disease\n* Primary or secondary immunodeficiency\n* Phenylketonuria (PKU) (ondansetron tablets may contain phenylalanine)\n* Use of systemic steroids within 30 days of screening\n* Chemotherapy, radiotherapy, or any systemic immunosuppressive drugs in the past 12 months\n* Use of biologic drugs or allergen-specific immunotherapy by any route in the past 12 months\n* Inability to defer routine immunizations or passive immunization with immune globulin for the duration of participation in the study\n* Allergy to any of the following medications: ondansetron (Zofran), dolasetron (Azemet), granisetron (Kytril), or palonosetron (Aloxi)\n* Pregnancy or breastfeeding\n* Current or past medical problems or findings from the physical examination or screening evaluation not listed above, which, in the opinion of the investigator(s), may pose additional risks from study participation, interfere with the participant's ability to comply with study requirements, and\u002For impact the quality or interpretation of the data obtained from the study","1 Year","60 Years",{"count":63,"type":23},72,"INTERVENTIONAL",[66],"NA","This is a phase I multicenter clinical trial that aims to find the optimal dose for conducting a novel low-dose, multi-day oral food challenge (OFC) protocol for diagnosing food protein-induced enterocolitis syndrome (FPIES). Individuals ages 1-60 years with a history of suspected or confirmed FPIES will be eligible for enrollment. Recruitment is expected to occur over 3 years.",[30],[70,71,72,73,74],"Allergy","FPIES","Food protein-induced enterocolitis syndrome","Food","Diagnosis","2026-05-29",{"date":77,"type":44},"2026-06-01",{"date":79,"type":44},"2025-02-24",{"date":81,"type":23},"2028-01",{"name":83,"class":51},"NYU Langone Health"]