Non-Immunoglobulin E-mediated Food Allergies in Children

Study Overview
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Brief Summary
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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.

Official Title
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Investigating Clinical Features, Natural Course and Pathophysiology of Non-Immunoglobulin E-mediated Food Allergies in the Pediatric Age

Conditions
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Non IgE Mediated Food Allergy, Food Protein-Induced Enteropathy, Food Protein-Induced Proctocolitis, Food Protein-Induced Enterocolitis Syndrome, Food Protein-induced Motility Disorders

Intervention / Treatment
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* Other: Non IgE-mediated food allergy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects aged between 0-14 years suggestive history of food allergy Exclusion Criteria: age >14 years- chronic systemic diseases, malignancy, immunodeficiency, infectious diseases, autoimmune diseases, 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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non IgE-mediated food allergy<br>Children with non IgE-mediated food allergy | Other: Non IgE-mediated food allergy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | After 72 months from the study start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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