About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
subjects aged between 0-14 years
suggestive history of food allergy
Disqualifiers
age >14 years-
chronic systemic diseases,
malignancy,
immunodeficiency,
Trial 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
Trial design
Cohort
Prospective
Treatments tested in this trial
Non IgE-mediated food allergy
Other intervention
Treatment groups
Trial outcomes
Primary outcomes
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
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)
Secondary outcomes
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
Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
Evaluation of epigenetic mechanisms
Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
Evaluation of immune cells phenotype
Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
Evaluation of mithocondrial metabolism of human lymphocytes
Sponsors and contacts
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