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Study of Children With Acute Food Protein Induced Enterocolitis Syndrome

Pathways of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form : a Multicentre Prospective Study - National FPIES Observatory

Not applicable Interventional Fondation Lenval · NCT05528900

This study is trying to gather information about children with a rare food allergy called FPIES to better understand their symptoms and how the condition changes over time.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment600 (estimated)
AgesN/A to 17 Years
SexAll
SponsorFondation Lenval Academic / other
Locations19 sites (Angers and 18 other locations)
Trial IDNCT05528900 on ClinicalTrials.gov

What this trial studies

This study aims to collect clinical features and allergy testing data from children diagnosed with acute Food Protein Induced Enterocolitis Syndrome (FPIES) over a three-year period. FPIES is a non-IgE mediated food allergy that can lead to severe gastrointestinal symptoms, often misdiagnosed due to its rarity and the lack of awareness among clinicians. The study will utilize established diagnostic criteria to ensure accurate identification of affected children and monitor their condition over time. The findings will help to better understand the evolution and atypical presentations of FPIES in the pediatric population.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 0 to 17 years who exhibit symptoms consistent with acute FPIES and have been evaluated by an allergist.

Not a fit: Patients with associated pathologies that contraindicate oral food challenges may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the diagnosis and management of FPIES in children, leading to better health outcomes.

How similar studies have performed: While there is limited literature on FPIES, the study builds on established diagnostic criteria and aims to fill a gap in understanding this condition, suggesting a novel approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Angers and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Food Protein Induced Enterocolitis SyndromeNon IgE mediated food allergyFPIES,children
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.