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A Multicentre French Prospective Study of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form

RecruitingNAAges any - 17 YearsAllFondation Lenval
NCT05528900 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * age from 0 to 17 years old, * 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, * affiliated to social security (public healthcare system) * signed consent of one of the parents or the holder of parental authority Exclusion Criteria: * 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.
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What it tests

  • allergy test
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Where

19 sites
Chu Angers
Angers, France
Chi Robert Ballanger
Aulnay-sous-Bois, France
Chu Clermont-Ferrand
Clermont-Ferrand, France
Hopital Civils de Colmar
Colmar, France
Chu Grenoble
Grenoble, France
Ch Haguenau
Haguenau, France
Chr Lille Hopital Jeanne de Flandre
Lille, France
Hopital Saint Vincent de Paul Ghicl
Lille, France

…and 11 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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