Actively Recruiting

Phase Not Applicable
Age: 0 - 17Years
All Genders
ID05528900

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

Age: 0 - 17Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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