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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non IgE-mediated food allergy | Children with non IgE-mediated food allergy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non IgE-mediated food allergy | Other |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Naples Federico II | Recruiting | Naples | 80131 | Italy |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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Stool samples Peripheral blood samples
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 |