Clinical trial Recruiting at 12 sites Interventional Ages Any age to 17

Study of Children With Acute Food Protein Induced Enterocolitis Syndrome

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

Run by Fondation Lenval · NCT05528900 · Data updated 2026-11-12

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

Study typeInterventional
AgesAny age to 17 Years
SexAll
Enrollment600 (estimated)
SponsorFondation Lenval
Academic / other
Locations19 sites (Angers and 18 other locations)
StatusRecruiting
StartedMarch 31, 2023
Main results expectedOctober 2025
Study endsOctober 2028
Registry record updatedSeptember 29, 2023
Trial IDNCT05528900 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Chu Angers
    Angers, France
    Recruiting
  • Chi Robert Ballanger
    Aulnay-sous-Bois, France
    Recruiting
  • Chu Clermont-Ferrand
    Clermont-Ferrand, France
    Recruiting
  • Hopital Civils de Colmar
    Colmar, France
    Recruiting
  • Ch Haguenau
    Haguenau, France
    Recruiting
  • Chr Lille Hopital Jeanne de Flandre
    Lille, France
    Recruiting
Show 13 more locations
  • Hopital Civil de Lyon
    Lyon, France
    Recruiting
  • Chu Montpellier
    Montpellier, France
    Recruiting
  • Chu Nancy
    Nancy, France
    Recruiting
  • Hôpitaux Pédiatriques de Nice CHU-Lenval
    Nice, France
    Recruiting
  • Hopital Ambroise Pare Aphp
    Paris, France
    Recruiting
  • Chu Rouen
    Rouen, France
    Recruiting
  • Chu Grenoble
    Grenoble, France
    Not yet recruiting
  • Hopital Saint Vincent de Paul Ghicl
    Lille, France
    Not yet recruiting
  • Cabinet Berlioz
    Nice, France
    Not yet recruiting
  • Aphp Armand Trousseau
    Paris, France
    Not yet recruiting
  • Hopital Necker Enfants Malades Aphp
    Paris, France
    Not yet recruiting
  • Hopital Robert Debre Aphp
    Paris, France
    Not yet recruiting
  • Cabinet Chabbert
    Toulouse, France
    Not yet recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 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.