RecruitingNot Applicable

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

France600 participantsStarted 2023-03-31

Plain-language summary

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

Who can participate

Age range17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

tolerance acquisition

Timeframe: through study completion, an average of 6 years

Trial details

NCT IDNCT05528900

SponsorFondation Lenval

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10

Contact for this trial

Sibylle BLANC, MD

0492030841 blanc.si@pediatrie-chulenval-nice.fr