[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479893":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":43,"studyPopulation":36,"armGroups":44,"interventions":50,"overallOfficials":36,"centralContacts":56,"locations":66,"responsibleParty":265,"collaborators":36,"id":267,"slug":36,"hasResults":268,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":268,"sex":274,"minAge":36,"maxAge":275,"enrollmentInfo":276,"targetDuration":36,"studyType":279,"phases":280,"briefSummary":281,"conditions":282,"keywords":284,"overallStatus":69,"whyStopped":36,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":297},{"fullName":5,"class":6},"Fondation Lenval","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"tolerance acquisition","The acquisition of tolerance will be defined by negative OFC or accidental intake of the food at home tolerated according to parents discussion","through study completion, an average of 6 years",[14,17,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":12},"population description","The description of the population included will be made according to the clinical, the demographic data, the allergy tests, the history of the disease",{"measure":18,"description":19,"timeFrame":20},"IgE sensitization","IgE sensitization is defined by the positivity of an immediate-read skin test (wheal of the prick test greater than half of the positive histamine control) and\u002For the presence of specific IgE antibody on a blood sample (≥0.35 kU\u002FL).","at 1 year, 2 years, 3 years post inclusion",{"measure":22,"description":23,"timeFrame":20},"food sensitization","food sensitization is defined by the positivity of an immediate-read skin test (wheal of the prick test greater than half of the positive histamine control)",{"measure":25,"description":26,"timeFrame":20},"IgE-mediated allergy","IgE-mediated allergy is defined by the demonstration of clinical symptoms related to the presence of these specific IgEs.",{"measure":28,"description":29,"timeFrame":20},"IgE-dependent allergy","IgE-dependent allergy will be defined by the appearance of symptoms a few minutes to 2 hours after ingestion of the food, with skin signs (urticaria, angioedema) and\u002For respiratory symptoms (dyspnea, laryngospasm, cough, bronchospasm ); digestive and neurological signs being potentially common with the diagnosis of FPIES",{"measure":31,"description":32,"timeFrame":20},"multiple FPIES","A multiple FPIES will be defined by the presence of clinical symptoms of FPIES for at least two different foods",{"measure":34,"description":35,"timeFrame":20},"Atopic comorbidities","Atopic comorbidities will be defined by asthma, allergic rhinitis, atopic dermatitis, and eosinophilic esophagitis",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":42,"maskingDescription":36,"whoMasked":36},"NONE","Food protein induced enterocolitis syndrome (FPIES), is a non-IgE mediated food allergy (FA) which seems to expand, and occurring in infancy. Prevalence of FPIES is unknown. In 2011, Katz published cumulative incidence of cow 'milk FPIES of 3 per 1000 new-borns, from prospective birth cohort in Israel.\n\nThe offending food depend on the country, probably in relation to eating habits.\n\nCow's milk (CM) is most commonly incriminated and can lead to a chronic digestive disease or in its acute form with potentially life-threatening vomiting\u002Fdiarrhoea\u002Fdehydration, confusing with anaphylaxis. Rice and oat in US, or fish and egg in France are the solid food most often implicated.\n\nThis disease is usually unknown by clinicians. Its diagnostic is based on clinical history, and differential diagnosis elimination.\n\nIn 2017, an international workgroup of American Academy of Allergy, Asthma and Immunology published clinical criteria to specify the diagnosis and management. According to this last definition (JACI 2017), patient have to meet the major criterion and at least 3 minor criteria. Major criterion is vomiting in the 1- to 4-h period after ingestion of the suspect food and absence of classic IgE-mediated allergic skin or respiratory symptoms. Minor criteria are :\n\n1. A second (or more) episode of repetitive vomiting after eating the same suspect food,\n2. Repetitive vomiting episode 1-4 h after eating a different food\n3. Extreme lethargy with any suspected reaction\n4. Marked pallor with any suspected reaction\n5. Need for emergency department visit with any suspected reaction\n6. Need for intravenous fluid support with any suspected reaction\n7. Diarrhea in 24 h (usually 5-10 h)\n8. Hypotension\n9. Hypothermia Skin prick test et IgE antibody are negative except atypical FPIES. Acute management begins with clinical evaluation, then administer normal saline bolus quickly. Parenteral ondansetron can be used to stop vomiting. Nutritional management implicate elimination of the offending foods. Only the oral food challenge in hospital can be done to determine resolution of FPIES after a long time of no symptom.\n\nThe age of tolerance, depend of the food. The average age of acquiring tolerance for cow's milk changes in the literature, around 8-10 months in Korea, around 1 year in Israel, around 5 years in the United States. There is no data in France on the recovery age of CM-FPIES.\n\nHowever, there is a lack of information in literature for describe the evolution and atypical phenotypes. In addition, no prospective French series has been published to date.\n\nOur work is a national prospective study, which will collect news cases of acute FPIES diagnosis in sixteen French centres.\n\nMain objective: To determine the rate of acquisition of tolerance by food at 1 year, 2 years, 3 years post inclusion.\n\nSecondary objectives:\n\n* Description of a population of children with newly diagnosed FPIES. 2. Describe the rate of patients with FPIES progressing to IgE sensitization whatever the food at 1 year, 2 years, 3 years post inclusion.\n\n  3\\. Determine per food the rate of FPIES patients evolving towards IgE sensitization at 1 year, 2 years, 3 years post inclusion.\n\n  4\\. Describe the rate of patients with FPIES progressing to clinical symptoms of IgE-mediated allergy, whatever the food, at 1 year, 2 years, 3 years post inclusion.\n\n  5\\. Determine, by food, the rate of FPIES evolving towards clinical symptoms of IgE-mediated allergy at 1 year, 2 years, 3 years post inclusion.\n\n  6\\. Describe the rate of patients with multiple FPIES at each time point of the study.\n\n  7\\. Describe at each time the rates of patients with personal atopic comorbidities.\n\nThe inclusion period will last three years, and the follow up of each patient will last three years.\n\nAllergologist will see the patient at inclusion visit, then one time a year. If the patient does not acquire tolerance, an oral food challenge (OFC) in hospital will lead to answer.\n\nThe aim of our work will help allergologist to manage FPIES children, with French specificities in offending food, and tolerance.",[45],{"label":46,"type":47,"description":36,"interventionNames":48},"FPEIS children","EXPERIMENTAL",[49],"Diagnostic Test: allergy test",[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":36},"DIAGNOSTIC_TEST","allergy test","allergy test are oral food challenge , prick test and IgE blood rate",[46],[57,62],{"name":58,"role":59,"phone":60,"phoneExt":36,"email":61},"Sibylle BLANC, MD","CONTACT","0492030841","blanc.si@pediatrie-chulenval-nice.fr",{"name":63,"role":59,"phone":64,"phoneExt":36,"email":65},"Dominique Donzeau","0492034560","donzeau.d@chu-nice.fr",[67,82,93,104,115,127,138,149,157,168,179,190,201,208,219,227,235,243,254],{"facility":68,"status":69,"city":70,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Chu Angers","RECRUITING","Angers","France","FR",{"type":74,"coordinates":75},"Point",[76,77],-0.55202,47.47156,{"lat":77,"lon":76},[80],{"name":81,"role":59,"phone":36,"phoneExt":36,"email":36},"ANNE HOPPE, MD",{"facility":83,"status":69,"city":84,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Chi Robert Ballanger","Aulnay-sous-Bois",{"type":74,"coordinates":86},[87,88],2.49402,48.93814,{"lat":88,"lon":87},[91],{"name":92,"role":59,"phone":36,"phoneExt":36,"email":36},"ARIANNE NEMNI",{"facility":94,"status":69,"city":95,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Chu Clermont-Ferrand","Clermont-Ferrand",{"type":74,"coordinates":97},[98,99],3.08682,45.77969,{"lat":99,"lon":98},[102],{"name":103,"role":59,"phone":36,"phoneExt":36,"email":36},"ELODIE MICHAUD",{"facility":105,"status":69,"city":106,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Hopital Civils de Colmar","Colmar",{"type":74,"coordinates":108},[109,110],7.35584,48.08078,{"lat":110,"lon":109},[113],{"name":114,"role":59,"phone":36,"phoneExt":36,"email":36},"JESSICA LOGLI",{"facility":116,"status":117,"city":118,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Chu Grenoble","NOT_YET_RECRUITING","Grenoble",{"type":74,"coordinates":120},[121,122],5.71479,45.17869,{"lat":122,"lon":121},[125],{"name":126,"role":59,"phone":36,"phoneExt":36,"email":36},"VIRGINIE JUBIN",{"facility":128,"status":69,"city":129,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Ch Haguenau","Haguenau",{"type":74,"coordinates":131},[132,133],7.79051,48.81557,{"lat":133,"lon":132},[136],{"name":137,"role":59,"phone":36,"phoneExt":36,"email":36},"CARINE FAVRE-METZ",{"facility":139,"status":69,"city":140,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Chr Lille Hopital Jeanne de Flandre","Lille",{"type":74,"coordinates":142},[143,144],3.05512,50.63391,{"lat":144,"lon":143},[147],{"name":148,"role":59,"phone":36,"phoneExt":36,"email":36},"ANTOINE DESCHILDRE",{"facility":150,"status":117,"city":140,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":151,"geoPoint":153,"contacts":154},"Hopital Saint Vincent de Paul Ghicl",{"type":74,"coordinates":152},[143,144],{"lat":144,"lon":143},[155],{"name":156,"role":59,"phone":36,"phoneExt":36,"email":36},"NICOLAS KALACH",{"facility":158,"status":69,"city":159,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Hopital Civil de Lyon","Lyon",{"type":74,"coordinates":161},[162,163],4.84789,45.74906,{"lat":163,"lon":162},[166],{"name":167,"role":59,"phone":36,"phoneExt":36,"email":36},"PRISCILLE BIERME",{"facility":169,"status":69,"city":170,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Chu Montpellier","Montpellier",{"type":74,"coordinates":172},[173,174],3.87635,43.61093,{"lat":174,"lon":173},[177],{"name":178,"role":59,"phone":36,"phoneExt":36,"email":36},"DAVIDE CAIMMI",{"facility":180,"status":69,"city":181,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Chu 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Trousseau","Paris",{"type":74,"coordinates":212},[213,214],2.3488,48.85341,{"lat":214,"lon":213},[217],{"name":218,"role":59,"phone":36,"phoneExt":36,"email":36},"ANAIS LEMOINE",{"facility":220,"status":69,"city":210,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":221,"geoPoint":223,"contacts":224},"Hopital Ambroise Pare Aphp",{"type":74,"coordinates":222},[213,214],{"lat":214,"lon":213},[225],{"name":226,"role":59,"phone":36,"phoneExt":36,"email":36},"GREGOIRE BENOIST",{"facility":228,"status":117,"city":210,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":229,"geoPoint":231,"contacts":232},"Hopital Necker Enfants Malades Aphp",{"type":74,"coordinates":230},[213,214],{"lat":214,"lon":213},[233],{"name":234,"role":59,"phone":36,"phoneExt":36,"email":36},"GUILLAUME LEZMI",{"facility":236,"status":117,"city":210,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":237,"geoPoint":239,"contacts":240},"Hopital Robert Debre Aphp",{"type":74,"coordinates":238},[213,214],{"lat":214,"lon":213},[241],{"name":242,"role":59,"phone":36,"phoneExt":36,"email":36},"FLORE AMAT",{"facility":244,"status":69,"city":245,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":246,"geoPoint":250,"contacts":251},"Chu Rouen","Rouen",{"type":74,"coordinates":247},[248,249],1.09932,49.44313,{"lat":249,"lon":248},[252],{"name":253,"role":59,"phone":36,"phoneExt":36,"email":36},"LAURE COUDERC",{"facility":255,"status":117,"city":256,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"Cabinet Chabbert","Toulouse",{"type":74,"coordinates":258},[259,260],1.44367,43.60426,{"lat":260,"lon":259},[263],{"name":264,"role":59,"phone":36,"phoneExt":36,"email":36},"ANNE CHABBERT",{"type":266,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100479893",false,"NCT05528900","A Multicentre French Prospective Study of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form","Pathways of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form : a Multicentre Prospective Study - National FPIES Observatory","SEIPA-FPIES","Inclusion Criteria:\n\n* age from 0 to 17 years old,\n* seen in allergologist visit for acute FPIES, due to history of suggestive clinical symptoms, confirmed by the criteria published in 2017 in the JACI (Nowak-Wegrzyn et al, JACI 2017), or by an oral food challenge for diagnosis in the absence of the requested clinical criteria,\n* affiliated to social security (public healthcare system)\n* signed consent of one of the parents or the holder of parental authority\n\nExclusion Criteria:\n\n* Associated pathology that may contraindicate OFC at the discretion of the investigating physician. In particular justifying permanent treatment with a beta-blocker or an angiotensin-converting enzyme inhibitor.","ALL","17 Years",{"count":277,"type":278},600,"ESTIMATED","INTERVENTIONAL",[38],"Food protein induced enterocolitis syndrome (FPIES), is a non-IgE mediated food allergy (FA) which seems to expand, and occurring in infancy. This disease is usually unknown by clinicians. In 2017, an international workgroup of American Academy of Allergy, Asthma and Immunology published clinical criteria to specify the diagnosis. However, there is a lack of information in literature for describe the evolution and atypical phenotypes. In addition, no prospective French series has been published to date. The aim of the study is to collect clinical features and allergy testing of children who have acute form of FPIES at diagnosis and during evolution during three years",[283],"Food Protein Induced Enterocolitis Syndrome (FPIES)",[285,286,287],"Non IgE mediated food allergy","FPIES,","children","2023-09-28",{"date":290,"type":291},"2023-09-29","ACTUAL",{"date":293,"type":291},"2023-03-31",{"date":295,"type":278},"2028-10",{"name":5,"class":6},19]