A Multicentre French Prospective Study of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorFondation Lenval
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
allergy test
Diagnostic testallergy test are oral food challenge , prick test and IgE blood rate
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: FPEIS childrenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
through study completion, an average of 6 yearsSecondary outcomes
1
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
Time frame
through study completion, an average of 6 years2
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/or the presence of specific IgE antibody on a blood sample (≥0.35 kU/L).
Time frame
at 1 year, 2 years, 3 years post inclusion3
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)
Time frame
at 1 year, 2 years, 3 years post inclusion4
IgE-mediated allergy
IgE-mediated allergy is defined by the demonstration of clinical symptoms related to the presence of these specific IgEs.
Time frame
at 1 year, 2 years, 3 years post inclusionSponsors and contacts
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Source ClinicalTrials.gov