Food Protein Induced Enterocolitis Syndrome (FPIES)SEIPA-FPIESNCT05528900
A Multicentre French Prospective Study of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form
A study testing allergy test in people with Food Protein Induced Enterocolitis Syndrome (FPIES), run by Fondation Lenval at 19 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Food Protein Induced Enterocolitis Syndrome (FPIES)
- What is being tested?
- allergy test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 19 sitesFrance
- Study dates
- 31 Mar 2023to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
France19 sites, 19 recruiting
- Recruiting
Chu Angers
Angers
ANNE HOPPE, MD
- Recruiting
Chi Robert Ballanger
Aulnay-sous-Bois
ARIANNE NEMNI
- Recruiting
Chu Clermont-Ferrand
Clermont-Ferrand
ELODIE MICHAUD
- Recruiting
Hopital Civils de Colmar
Colmar
JESSICA LOGLI
- Not yet recruiting
Chu Grenoble
Grenoble
VIRGINIE JUBIN
- Recruiting
Ch Haguenau
Haguenau
CARINE FAVRE-METZ
- Recruiting
Chr Lille Hopital Jeanne de Flandre
Lille
ANTOINE DESCHILDRE
- Not yet recruiting
Hopital Saint Vincent de Paul Ghicl
Lille
NICOLAS KALACH
- Recruiting
Hopital Civil de Lyon
Lyon
PRISCILLE BIERME
- Recruiting
Chu Montpellier
Montpellier
DAVIDE CAIMMI
- Recruiting
Chu Nancy
Nancy
AMANDINE DIVARET-CHAUVEAU
- Not yet recruiting
Cabinet Berlioz
Nice
MICHELE BERLIOZ
- Recruiting
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice
Sibylle BLANC, MD, 0492030841, blanc.si@pediatrie-chulenval-nice.fr
- Not yet recruiting
Aphp Armand Trousseau
Paris
ANAIS LEMOINE
- Recruiting
Hopital Ambroise Pare Aphp
Paris
GREGOIRE BENOIST
- Not yet recruiting
Hopital Necker Enfants Malades Aphp
Paris
GUILLAUME LEZMI
- Not yet recruiting
Hopital Robert Debre Aphp
Paris
FLORE AMAT
- Recruiting
Chu Rouen
Rouen
LAURE COUDERC
- Not yet recruiting
Cabinet Chabbert
Toulouse
ANNE CHABBERT
About this study
Official title: 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
Read the 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 :
- A second (or more) episode of repetitive vomiting after eating the same suspect food,
- Repetitive vomiting episode 1-4 h after eating a different food
- Extreme lethargy with any suspected reaction
- Marked pallor with any suspected reaction
- Need for emergency department visit with any suspected reaction
- Need for intravenous fluid support with any suspected reaction
- Diarrhea in 24 h (usually 5-10 h)
- Hypotension
- 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.
- Determine per food the rate of FPIES patients evolving towards IgE sensitization at 1 year, 2 years, 3 years post inclusion.
- 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.
- Determine, by food, the rate of FPIES evolving towards clinical symptoms of IgE-mediated allergy at 1 year, 2 years, 3 years post inclusion.
- Describe the rate of patients with multiple FPIES at each time point of the study.
- 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.
- Being tested
- allergy test
- Keywords
- Non IgE mediated food allergy, FPIES,, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allergy testDiagnostic test
allergy test are oral food challenge , prick test and IgE blood rate
| Study group | Role | What they receive |
|---|---|---|
| FPEIS children | Experimental | Not described Receives: Diagnostic Test: allergy test |
What is being measured
The primary outcome is the main question the study is designed to answer.
tolerance acquisition
The acquisition of tolerance will be defined by negative OFC or accidental intake of the food at home tolerated according to parents discussion
Measured: through study completion, an average of 6 years
Secondary outcomes (7)
population description
The description of the population included will be made according to the clinical, the demographic data, the allergy tests, the history of the disease
Measured: through study completion, an average of 6 years
IgE sensitization
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).
Measured: at 1 year, 2 years, 3 years post inclusion
food sensitization
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)
Measured: at 1 year, 2 years, 3 years post inclusion
IgE-mediated allergy
IgE-mediated allergy is defined by the demonstration of clinical symptoms related to the presence of these specific IgEs.
Measured: at 1 year, 2 years, 3 years post inclusion
IgE-dependent allergy
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
Measured: at 1 year, 2 years, 3 years post inclusion
multiple FPIES
A multiple FPIES will be defined by the presence of clinical symptoms of FPIES for at least two different foods
Measured: at 1 year, 2 years, 3 years post inclusion
Atopic comorbidities
Atopic comorbidities will be defined by asthma, allergic rhinitis, atopic dermatitis, and eosinophilic esophagitis
Measured: at 1 year, 2 years, 3 years post inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start31 Mar 2023
- Primary completionOct 2025 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Protein Induced Enterocolitis Syndrome (FPIES)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528900
- Sponsor's protocol ID
- 21-HPNCL-03
- Acronym
- SEIPA-FPIES
- Status last verified
- Mar 2023
- First submitted
- 29 Jul 2022
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathways of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form : a Multicentre Prospective Study - National FPIES Observatory
- ClinicalTrials.gov ID
- NCT05528900
- Acronym / sponsor ID
- SEIPA-FPIES / 21-HPNCL-03
- Keywords
- Non IgE mediated food allergy, FPIES,, children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 :
- A second (or more) episode of repetitive vomiting after eating the same suspect food,
- Repetitive vomiting episode 1-4 h after eating a different food
- Extreme lethargy with any suspected reaction
- Marked pallor with any suspected reaction
- Need for emergency department visit with any suspected reaction
- Need for intravenous fluid support with any suspected reaction
- Diarrhea in 24 h (usually 5-10 h)
- Hypotension
- 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.
- Determine per food the rate of FPIES patients evolving towards IgE sensitization at 1 year, 2 years, 3 years post inclusion.
- 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.
- Determine, by food, the rate of FPIES evolving towards clinical symptoms of IgE-mediated allergy at 1 year, 2 years, 3 years post inclusion.
- Describe the rate of patients with multiple FPIES at each time point of the study.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FPEIS children | Experimental | Diagnostic Test: allergy test |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allergy testallergy test are oral food challenge , prick test and IgE blood rate | Diagnostic test | FPEIS children |
Primary outcome
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
7 secondary outcomes
population description
Time frame: through study completion, an average of 6 years
IgE sensitization
Time frame: at 1 year, 2 years, 3 years post inclusion
food sensitization
Time frame: at 1 year, 2 years, 3 years post inclusion
IgE-mediated allergy
Time frame: at 1 year, 2 years, 3 years post inclusion
IgE-dependent allergy
Time frame: at 1 year, 2 years, 3 years post inclusion
multiple FPIES
Time frame: at 1 year, 2 years, 3 years post inclusion
Atopic comorbidities
Time frame: at 1 year, 2 years, 3 years post inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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FPIES
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing allergy test in people with Food Protein Induced Enterocolitis Syndrome (FPIES), run by Fondation Lenval at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sibylle BLANC, MD (0492030841, blanc.si@pediatrie-chulenval-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tolerance acquisition (time frame: through study completion, an average of 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.