Actively Recruiting
Pathways of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form A Multicentre Prospective Study - National FPIES Observatory
Led by Fondation Lenval · Updated on 2023-09-29
600
Participants Needed
19
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Food Protein Induced Enterocolitis Syndrome (FPIES) is a type of non-IgE mediated food allergy that usually occurs in infancy and is often not well known by clinicians. The study aims to collect clinical information and allergy test results from children diagnosed with the acute form of FPIES and to observe their condition over three years. It seeks to better understand the evolution of FPIES, including atypical forms, with no prior prospective data available from France. Children diagnosed with acute FPIES will be followed in this national prospective study conducted at sixteen French centers. Allergy tests such as oral food challenges, skin prick tests, and IgE blood tests will be used for diagnosis and monitoring. Patients will be seen at an initial visit and then annually for up to three years. If tolerance to the offending food is not acquired, an oral food challenge will be performed in the hospital for confirmation. Participants will undergo yearly allergist visits for evaluation of symptoms and allergy testing. Researchers will measure the rate of tolerance acquisition to foods over one, two, and three years post-inclusion, as well as the progression to IgE sensitization and clinical IgE-mediated allergy. Additional outcomes include the presence of multiple FPIES episodes and related atopic conditions. The study will provide insights into the natural history and management of FPIES in children.
CONDITIONS
Brief Title
A Multicentre French Prospective Study of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 0 to 17 years old
- Seen by an allergologist for acute FPIES with suggestive clinical symptoms confirmed by 2017 JACI criteria or by oral food challenge
- Affiliated to social security (public healthcare system)
- Signed consent from a parent or legal guardian
You will not qualify if you...
- Presence of associated conditions that may contraindicate oral food challenge as determined by the physician
- Ongoing treatment with beta-blockers
- Ongoing treatment with angiotensin-converting enzyme inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years post inclusion
Participants undergo allergy tests including oral food challenge, prick test, and IgE blood tests to diagnose FPIES.
Annual visits for up to 3 years
Duration - Up to 3 years post inclusion
Participants are monitored to determine tolerance acquisition and progression of allergy symptoms over time.
Annual visits for up to 3 years
Trial Site Locations
Total: 19 locations
1
Chu Angers
Angers, France
Actively Recruiting
2
Chi Robert Ballanger
Aulnay-sous-Bois, France
Actively Recruiting
3
Chu Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
4
Hopital Civils de Colmar
Colmar, France
Actively Recruiting
5
Chu Grenoble
Grenoble, France
Not Yet Recruiting
6
Ch Haguenau
Haguenau, France
Actively Recruiting
7
Chr Lille Hopital Jeanne de Flandre
Lille, France
Actively Recruiting
8
Hopital Saint Vincent de Paul Ghicl
Lille, France
Not Yet Recruiting
9
Hopital Civil de Lyon
Lyon, France
Actively Recruiting
10
Chu Montpellier
Montpellier, France
Actively Recruiting
11
Chu Nancy
Nancy, France
Actively Recruiting
12
Cabinet Berlioz
Nice, France
Not Yet Recruiting
13
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice, France
Actively Recruiting
14
Aphp Armand Trousseau
Paris, France
Not Yet Recruiting
15
Hopital Ambroise Pare Aphp
Paris, France
Actively Recruiting
16
Hopital Necker Enfants Malades Aphp
Paris, France
Not Yet Recruiting
17
Hopital Robert Debre Aphp
Paris, France
Not Yet Recruiting
18
Chu Rouen
Rouen, France
Actively Recruiting
19
Cabinet Chabbert
Toulouse, France
Not Yet Recruiting
Research Team
S
Sibylle BLANC, MD
D
Dominique Donzeau
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Frequently Asked Questions
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