A Multicentre French Prospective Study of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form (SEIPA-FPIES)

September 28, 2023 updated by: Fondation Lenval

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

Food protein induced enterocolitis syndrome (FPIES), is a non-IgE mediated food allergy (FA) which seems to expand, and occurring in infancy. This disease is usually unknown by clinicians. In 2017, an international workgroup of American Academy of Allergy, Asthma and Immunology published clinical criteria to specify the diagnosis. However, there is a lack of information in literature for describe the evolution and atypical phenotypes. In addition, no prospective French series has been published to date. The aim of the study is to collect clinical features and allergy testing of children who have acute form of FPIES at diagnosis and during evolution during three years

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Food protein induced enterocolitis syndrome (FPIES), is a non-IgE mediated food allergy (FA) which seems to expand, and occurring in infancy. Prevalence of FPIES is unknown. In 2011, Katz published cumulative incidence of cow 'milk FPIES of 3 per 1000 new-borns, from prospective birth cohort in Israel.

The offending food depend on the country, probably in relation to eating habits.

Cow's milk (CM) is most commonly incriminated and can lead to a chronic digestive disease or in its acute form with potentially life-threatening vomiting/diarrhoea/dehydration, confusing with anaphylaxis. Rice and oat in US, or fish and egg in France are the solid food most often implicated.

This disease is usually unknown by clinicians. Its diagnostic is based on clinical history, and differential diagnosis elimination.

In 2017, an international workgroup of American Academy of Allergy, Asthma and Immunology published clinical criteria to specify the diagnosis and management. According to this last definition (JACI 2017), patient have to meet the major criterion and at least 3 minor criteria. Major criterion is vomiting in the 1- to 4-h period after ingestion of the suspect food and absence of classic IgE-mediated allergic skin or respiratory symptoms. Minor criteria are :

  1. A second (or more) episode of repetitive vomiting after eating the same suspect food,
  2. Repetitive vomiting episode 1-4 h after eating a different food
  3. Extreme lethargy with any suspected reaction
  4. Marked pallor with any suspected reaction
  5. Need for emergency department visit with any suspected reaction
  6. Need for intravenous fluid support with any suspected reaction
  7. Diarrhea in 24 h (usually 5-10 h)
  8. Hypotension
  9. Hypothermia Skin prick test et IgE antibody are negative except atypical FPIES. Acute management begins with clinical evaluation, then administer normal saline bolus quickly. Parenteral ondansetron can be used to stop vomiting. Nutritional management implicate elimination of the offending foods. Only the oral food challenge in hospital can be done to determine resolution of FPIES after a long time of no symptom.

The age of tolerance, depend of the food. The average age of acquiring tolerance for cow's milk changes in the literature, around 8-10 months in Korea, around 1 year in Israel, around 5 years in the United States. There is no data in France on the recovery age of CM-FPIES.

However, there is a lack of information in literature for describe the evolution and atypical phenotypes. In addition, no prospective French series has been published to date.

Our work is a national prospective study, which will collect news cases of acute FPIES diagnosis in sixteen French centres.

Main objective: To determine the rate of acquisition of tolerance by food at 1 year, 2 years, 3 years post inclusion.

Secondary objectives:

  • Description of a population of children with newly diagnosed FPIES. 2. Describe the rate of patients with FPIES progressing to IgE sensitization whatever the food at 1 year, 2 years, 3 years post inclusion.

    3. Determine per food the rate of FPIES patients evolving towards IgE sensitization at 1 year, 2 years, 3 years post inclusion.

    4. Describe the rate of patients with FPIES progressing to clinical symptoms of IgE-mediated allergy, whatever the food, at 1 year, 2 years, 3 years post inclusion.

    5. Determine, by food, the rate of FPIES evolving towards clinical symptoms of IgE-mediated allergy at 1 year, 2 years, 3 years post inclusion.

    6. Describe the rate of patients with multiple FPIES at each time point of the study.

    7. Describe at each time the rates of patients with personal atopic comorbidities.

The inclusion period will last three years, and the follow up of each patient will last three years.

Allergologist will see the patient at inclusion visit, then one time a year. If the patient does not acquire tolerance, an oral food challenge (OFC) in hospital will lead to answer.

The aim of our work will help allergologist to manage FPIES children, with French specificities in offending food, and tolerance.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Angers, France
        • Recruiting
        • CHU Angers
        • Contact:
          • ANNE HOPPE, MD
      • Aulnay-sous-Bois, France
        • Recruiting
        • CHI Robert Ballanger
        • Contact:
          • ARIANNE NEMNI
      • Clermont-Ferrand, France
        • Recruiting
        • CHU clermont-ferrand
        • Contact:
          • ELODIE MICHAUD
      • Colmar, France
        • Recruiting
        • Hopital Civils de Colmar
        • Contact:
          • JESSICA LOGLI
      • Grenoble, France
        • Not yet recruiting
        • Chu Grenoble
        • Contact:
          • VIRGINIE JUBIN
      • Haguenau, France
        • Recruiting
        • CH Haguenau
        • Contact:
          • CARINE FAVRE-METZ
      • Lille, France
        • Recruiting
        • Chr Lille Hopital Jeanne de Flandre
        • Contact:
          • ANTOINE DESCHILDRE
      • Lille, France
        • Not yet recruiting
        • Hopital Saint Vincent de Paul Ghicl
        • Contact:
          • NICOLAS KALACH
      • Lyon, France
        • Recruiting
        • Hopital Civil de Lyon
        • Contact:
          • PRISCILLE BIERME
      • Montpellier, France
        • Recruiting
        • CHU Montpellier
        • Contact:
          • DAVIDE CAIMMI
      • Nancy, France
        • Recruiting
        • CHU Nancy
        • Contact:
          • AMANDINE DIVARET-CHAUVEAU
      • Nice, France
      • Nice, France
        • Not yet recruiting
        • Cabinet Berlioz
        • Contact:
          • MICHELE BERLIOZ
      • Paris, France
        • Not yet recruiting
        • Aphp Armand Trousseau
        • Contact:
          • ANAIS LEMOINE
      • Paris, France
        • Recruiting
        • Hopital Ambroise Pare Aphp
        • Contact:
          • GREGOIRE BENOIST
      • Paris, France
        • Not yet recruiting
        • Hopital Necker Enfants Malades Aphp
        • Contact:
          • GUILLAUME LEZMI
      • Paris, France
        • Not yet recruiting
        • Hôpital Robert Debré APHP
        • Contact:
          • FLORE AMAT
      • Rouen, France
        • Recruiting
        • CHU Rouen
        • Contact:
          • Laure COUDERC
      • Toulouse, France
        • Not yet recruiting
        • Cabinet Chabbert
        • Contact:
          • ANNE CHABBERT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FPEIS children
Diagnostic test: allergy test
allergy test are oral food challenge , prick test and IgE blood rate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
tolerance acquisition
Time Frame: through study completion, an average of 6 years
The acquisition of tolerance will be defined by negative OFC or accidental intake of the food at home tolerated according to parents discussion
through study completion, an average of 6 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
population description
Time Frame: through study completion, an average of 6 years
The description of the population included will be made according to the clinical, the demographic data, the allergy tests, the history of the disease
through study completion, an average of 6 years
IgE sensitization
Time Frame: at 1 year, 2 years, 3 years post inclusion
IgE sensitization is defined by the positivity of an immediate-read skin test (wheal of the prick test greater than half of the positive histamine control) and/or the presence of specific IgE antibody on a blood sample (≥0.35 kU/L).
at 1 year, 2 years, 3 years post inclusion
food sensitization
Time Frame: at 1 year, 2 years, 3 years post inclusion
food sensitization is defined by the positivity of an immediate-read skin test (wheal of the prick test greater than half of the positive histamine control)
at 1 year, 2 years, 3 years post inclusion
IgE-mediated allergy
Time Frame: at 1 year, 2 years, 3 years post inclusion
IgE-mediated allergy is defined by the demonstration of clinical symptoms related to the presence of these specific IgEs.
at 1 year, 2 years, 3 years post inclusion
IgE-dependent allergy
Time Frame: at 1 year, 2 years, 3 years post inclusion
IgE-dependent allergy will be defined by the appearance of symptoms a few minutes to 2 hours after ingestion of the food, with skin signs (urticaria, angioedema) and/or respiratory symptoms (dyspnea, laryngospasm, cough, bronchospasm ); digestive and neurological signs being potentially common with the diagnosis of FPIES
at 1 year, 2 years, 3 years post inclusion
multiple FPIES
Time Frame: at 1 year, 2 years, 3 years post inclusion
A multiple FPIES will be defined by the presence of clinical symptoms of FPIES for at least two different foods
at 1 year, 2 years, 3 years post inclusion
Atopic comorbidities
Time Frame: at 1 year, 2 years, 3 years post inclusion
Atopic comorbidities will be defined by asthma, allergic rhinitis, atopic dermatitis, and eosinophilic esophagitis
at 1 year, 2 years, 3 years post inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondation Lenval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-HPNCL-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings