Non IgE Mediated Food AllergyNIGEFANCT04462978
Non-Immunoglobulin E-mediated Food Allergies in Children
An observational study of Non IgE Mediated Food Allergy and Food Protein-Induced Enteropathy, run by Federico II University at 1 site in Italy.
Trial summary
Non-IgE-mediated gastrointestinal food allergies (non-IgE-GIFA) are an evolving web of clinical conditions characterized by subacute and/or chronic symptoms and include food protein-induced enterocolitis syndrome (FPIES), food protein-induced enteropathy (FPE), food protein-induced allergic proctocolitis (FPIAP), and… Read more about this study
- Who is it for?
- Ages 1 day to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Non IgE Mediated Food Allergy, Food Protein-Induced Enteropathy, Food Protein-Induced Proctocolitis
- What is being tested?
- Non IgE-mediated food allergy
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2017to 28 Dec 2027
- Phase
- Observational
- 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 1 day to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: subjects consecutively observed at the Pediatric Allergy Program, at the Department of Translational Medical Science of the University of Naples Federico II, both sex, aged between 0-14 years with suggestive history of food allergy
Who may be able to join
- subjects aged between 0-14 years
- suggestive history of food allergy
Who cannot join
- age >14 years-
- chronic systemic diseases,
- malignancy,
- immunodeficiency,
- infectious diseases,
- autoimmune diseases,
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- inflammatory bowel diseases,
- celiac disease,
- metabolic and genetic diseases,
- cystic fibrosis,
- chronic pulmonary diseases,
- gastrointestinal, respiratory, urinary tract and/or cardiovascular malformations,
- neurologic and/or neuropsychiatric disorders,
- gastrointestinal tract eosinophilic disorders,
- use of immunomodulating drugs, steroids, pre-pro-synbiotics, antibiotics in the previous 4 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University of Naples Federico II
Naples, 80131
Roberto Berni Canani, MD, PhD, +390817462680
About this study
Official title: Investigating Clinical Features, Natural Course and Pathophysiology of Non-Immunoglobulin E-mediated Food Allergies in the Pediatric Age
Non-IgE-mediated gastrointestinal food allergies (non-IgE-GIFA) are an evolving web of clinical conditions characterized by subacute and/or chronic symptoms and include food protein-induced enterocolitis syndrome (FPIES), food protein-induced enteropathy (FPE), food protein-induced allergic proctocolitis (FPIAP), and food protein-induced allergic dysmotility disorders (gastroesophageal reflux disease (GERD), colic and constipation) (FPIMD).
Despite the prevalence and clinical impact of these conditions, the pathogenesis as well as the natural history and the best management of these disorders are still poorly defined. These limitations could be responsible for diagnostic delays and errors, and suboptimal clinical management. We aim to evaluate clinical features, natural course and pathophysiology of non-IgE-GIFA in the pediatric age.
- Conditions
- Non IgE Mediated Food Allergy, Food Protein-Induced Enteropathy, Food Protein-Induced Proctocolitis, Food Protein-Induced Enterocolitis Syndrome, Food Protein-induced Motility Disorders
- Being tested
- Non IgE-mediated food allergy
- Keywords
- Food allergy, Adverse food reactions, Immune tolerance, Atopy patch test, Atopic march, Oral food challenge, Food Protein-Induced Enteropathy, Food Protein-Induced Proctocolitis, Food Protein-Induced Enterocolitis Syndrome, Food protein-induced motility disorders
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non IgE-mediated food allergyOther
| Study group | Role | What they receive |
|---|---|---|
| Non IgE-mediated food allergy | Children with non IgE-mediated food allergy Receives: Other: Non IgE-mediated food allergy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of clinical features and disease course of non-IgE mediated food allergies in children
Rate of pts affected by FPIES, FPE, FPIAP, FPIMD; diagnostic delay; disease duration, rate of pts with mono vs poli food allergies; main antigens responsible for the diseases; occurrence of atopic dermatitis before food allergy onset; results of allergy screening tests; occurrence of atopic march
Measured: After 72 months from the study start
Evaluation of clinical features of non-IgE mediated food allergies in children
Dietary management and Nutritional status (weight and height will be combined to report BMI z-score)
Measured: After 72 months from the study start
Secondary outcomes (5)
Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
Evaluation of serum levels of Th2, Th1, and Th17 cytokines
Measured: through study completion, an average of 2 years
Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
Evaluation of epigenetic mechanisms
Measured: through study completion, an average of 2 years
Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
Evaluation of immune cells phenotype
Measured: through study completion, an average of 2 years
Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
Evaluation of mithocondrial metabolism of human lymphocytes
Measured: through study completion, an average of 2 years
Evaluation of gut microbiome features in children with Non-IgE-mediated food allergies
Evaluation of gut microbiome structure and function
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Jan 2017
- Primary completion30 Dec 2023
- Study completion28 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non IgE Mediated Food AllergyStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462978
- Sponsor's protocol ID
- 102/20
- Acronym
- NIGEFA
- Status last verified
- Aug 2026
- First submitted
- 28 May 2020
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Clinical Features, Natural Course and Pathophysiology of Non-Immunoglobulin E-mediated Food Allergies in the Pediatric Age
- ClinicalTrials.gov ID
- NCT04462978
- Acronym / sponsor ID
- NIGEFA / 102/20
- Conditions
- Non IgE Mediated Food Allergy, Food Protein-Induced Enteropathy, Food Protein-Induced Proctocolitis, Food Protein-Induced Enterocolitis Syndrome, Food Protein-induced Motility Disorders
- Keywords
- Food allergy, Adverse food reactions, Immune tolerance, Atopy patch test, Atopic march, Oral food challenge, Food Protein-Induced Enteropathy, Food Protein-Induced Proctocolitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 28 Dec 2027 (estimated)
- First posted
- 8 Jul 2020 (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.
Non-IgE-mediated gastrointestinal food allergies (non-IgE-GIFA) are an evolving web of clinical conditions characterized by subacute and/or chronic symptoms and include food protein-induced enterocolitis syndrome (FPIES), food protein-induced enteropathy (FPE), food protein-induced allergic proctocolitis (FPIAP), and food protein-induced allergic dysmotility disorders (gastroesophageal reflux disease (GERD), colic and constipation) (FPIMD).
Despite the prevalence and clinical impact of these conditions, the pathogenesis as well as the natural history and the best management of these disorders are still poorly defined. These limitations could be responsible for diagnostic delays and errors, and suboptimal clinical management. We aim to evaluate clinical features, natural course and pathophysiology of non-IgE-GIFA in the pediatric age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non IgE-mediated food allergy | – | Other: Non IgE-mediated food allergyChildren with non IgE-mediated food allergy |
Who may qualify
- Ages
- 1 day to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- subjects consecutively observed at the Pediatric Allergy Program, at the Department of Translational Medical Science of the University of Naples Federico II, both sex, aged between 0-14 years with suggestive history of food allergy
Key inclusion criteria (2 listed)
- subjects aged between 0-14 years
- suggestive history of food allergy
Key exclusion criteria (15 listed)
- age >14 years-
- chronic systemic diseases,
- malignancy,
- immunodeficiency,
- infectious diseases,
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 |
|---|---|---|
| Non IgE-mediated food allergy | Other | Non IgE-mediated food allergy |
Primary outcome
Evaluation of clinical features and disease course of non-IgE mediated food allergies in children
Time frame: After 72 months from the study start
Rate of pts affected by FPIES, FPE, FPIAP, FPIMD; diagnostic delay; disease duration, rate of pts with mono vs poli food allergies; main antigens responsible for the diseases; occurrence of atopic dermatitis before food allergy onset; results of allergy screening tests; occurrence of atopic march
Evaluation of clinical features of non-IgE mediated food allergies in children
Time frame: After 72 months from the study start
Dietary management and Nutritional status (weight and height will be combined to report BMI z-score)
5 secondary outcomes
Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
Time frame: through study completion, an average of 2 years
Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
Time frame: through study completion, an average of 2 years
Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
Time frame: through study completion, an average of 2 years
Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
Time frame: through study completion, an average of 2 years
Evaluation of gut microbiome features in children with Non-IgE-mediated food allergies
Time frame: through study completion, an average of 2 years
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 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non IgE Mediated Food Allergy and Food Protein-Induced Enteropathy, run by Federico II University at 1 site in Italy.
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 2 inclusion and 15 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of clinical features and disease course of non-IgE mediated food allergies in children (time frame: After 72 months from the study start). The study lists 2 primary outcomes in all. 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 2 Sep 2026.