NCT05528900 A Multicentre French Prospective Study of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form
| NCT ID | NCT05528900 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Lenval |
| Condition | Food Protein Induced Enterocolitis Syndrome (FPIES) |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2023-03-31 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2023-03-31 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05528900 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Food Protein Induced Enterocolitis Syndrome (FPIES). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05528900 currently recruiting?
Yes, NCT05528900 is actively recruiting participants. Contact the research team at blanc.si@pediatrie-chulenval-nice.fr for enrollment information.
Where is the NCT05528900 trial being conducted?
This trial is being conducted at Angers, France, Aulnay-sous-Bois, France, Clermont-Ferrand, France, Colmar, France and 11 additional locations.
Who is sponsoring the NCT05528900 clinical trial?
NCT05528900 is sponsored by Fondation Lenval. The trial plans to enroll 600 participants.