Clinical Trial

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

Study acronym: SEIPA-FPIES

Recruiting

Record status

This record was last updated September 29, 2023 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.

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

Protocol Amendment History 2 amendments

This ClinicalTrials.gov record has been amended 2 times since 2022-09-02; most recent amendment 2023-09-28.

Status change: Not Yet Recruiting → Recruiting 2023-09-28

Trial Details

NCT Number	NCT05528900
Lead Sponsor	Fondation Lenval
Conditions	Food Protein Induced Enterocolitis Syndrome (FPIES)
Enrollment	600 participants
Start Date	2023-03-31
Primary Completion	2025-10 (estimated)
Study Completion	2028-10 (estimated)
Updated on ClinicalTrials.gov	2023-09-29