FARE - Food Allergy Research & Education Logo

A Multicentre French Prospective Study of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 17 Years
Gender All
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05528900
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fondation Lenval
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Protein Induced Enterocolitis Syndrome (FPIES)
Additional Details

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.

Arms & Interventions

Arms

Experimental: FPEIS children

Interventions

Diagnostic Test: - allergy test

allergy test are oral food challenge , prick test and IgE blood rate

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Chu Angers, Angers, France

Status

Recruiting

Address

Chu Angers

Angers, ,

Site Contact

ANNE HOPPE, MD

[email protected]

0492030841

Chi Robert Ballanger, Aulnay-sous-Bois, France

Status

Recruiting

Address

Chi Robert Ballanger

Aulnay-sous-Bois, ,

Site Contact

ARIANNE NEMNI

[email protected]

0492030841

Chu Clermont-Ferrand, Clermont-Ferrand, France

Status

Recruiting

Address

Chu Clermont-Ferrand

Clermont-Ferrand, ,

Site Contact

ELODIE MICHAUD

[email protected]

0492030841

Hopital Civils de Colmar, Colmar, France

Status

Recruiting

Address

Hopital Civils de Colmar

Colmar, ,

Site Contact

JESSICA LOGLI

[email protected]

0492030841

Chu Grenoble, Grenoble, France

Status

Not yet recruiting

Address

Chu Grenoble

Grenoble, ,

Site Contact

VIRGINIE JUBIN

[email protected]

0492030841

Ch Haguenau, Haguenau, France

Status

Recruiting

Address

Ch Haguenau

Haguenau, ,

Site Contact

CARINE FAVRE-METZ

[email protected]

0492030841

Chr Lille Hopital Jeanne de Flandre, Lille, France

Status

Recruiting

Address

Chr Lille Hopital Jeanne de Flandre

Lille, ,

Site Contact

ANTOINE DESCHILDRE

[email protected]

0492030841

Hopital Saint Vincent de Paul Ghicl, Lille, France

Status

Not yet recruiting

Address

Hopital Saint Vincent de Paul Ghicl

Lille, ,

Site Contact

NICOLAS KALACH

[email protected]

0492030841

Hopital Civil de Lyon, Lyon, France

Status

Recruiting

Address

Hopital Civil de Lyon

Lyon, ,

Site Contact

PRISCILLE BIERME

[email protected]

0492030841

Chu Montpellier, Montpellier, France

Status

Recruiting

Address

Chu Montpellier

Montpellier, ,

Site Contact

DAVIDE CAIMMI

[email protected]

0492030841

Chu Nancy, Nancy, France

Status

Recruiting

Address

Chu Nancy

Nancy, ,

Site Contact

AMANDINE DIVARET-CHAUVEAU

[email protected]

0492030841

Cabinet Berlioz, Nice, France

Status

Not yet recruiting

Address

Cabinet Berlioz

Nice, ,

Site Contact

MICHELE BERLIOZ

[email protected]

0492030841

Hôpitaux Pédiatriques de Nice CHU-Lenval, Nice, France

Status

Recruiting

Address

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, ,

Site Contact

Sibylle BLANC, MD

[email protected]

0492030841

Aphp Armand Trousseau, Paris, France

Status

Not yet recruiting

Address

Aphp Armand Trousseau

Paris, ,

Site Contact

ANAIS LEMOINE

[email protected]

0492030841

Hopital Ambroise Pare Aphp, Paris, France

Status

Recruiting

Address

Hopital Ambroise Pare Aphp

Paris, ,

Site Contact

GREGOIRE BENOIST

[email protected]

0492030841

Hopital Necker Enfants Malades Aphp, Paris, France

Status

Not yet recruiting

Address

Hopital Necker Enfants Malades Aphp

Paris, ,

Site Contact

GUILLAUME LEZMI

[email protected]

0492030841

Hopital Robert Debre Aphp, Paris, France

Status

Not yet recruiting

Address

Hopital Robert Debre Aphp

Paris, ,

Site Contact

FLORE AMAT

[email protected]

0492030841

Chu Rouen, Rouen, France

Status

Recruiting

Address

Chu Rouen

Rouen, ,

Site Contact

LAURE COUDERC

[email protected]

0492030841

Cabinet Chabbert, Toulouse, France

Status

Not yet recruiting

Address

Cabinet Chabbert

Toulouse, ,

Site Contact

ANNE CHABBERT

[email protected]

0492030841

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.