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
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.
- 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