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 type | Interventional |
|---|---|
| Ages | Any age to 17 Years |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Fondation Lenval Academic / other |
| Locations | 19 sites (Angers and 18 other locations) |
| Status | Recruiting |
| Started | March 31, 2023 |
| Main results expected | October 2025 |
| Study ends | October 2028 |
| Registry record updated | September 29, 2023 |
| Trial ID | NCT05528900 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
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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
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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
- Study coordinator: Sibylle BLANC, MD
- Email: blanc.si@pediatrie-chulenval-nice.fr
- Phone: 0492030841
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Finding the best way to diagnose food protein-induced enterocolitis syndrome
This study is testing a new way to diagnose food protein-induced enterocolitis syndrome (FPIES) in people aged 1-60 by giving them small amounts of food to see how they react.
-
Understanding Non-IgE-mediated Food Allergies in Children
This study is trying to learn more about non-IgE-mediated food allergies in children, like certain gastrointestinal issues, to help improve how these allergies are understood and managed.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.