Non-Immunoglobulin E-mediated Food Allergies in Children

Federico II University150 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

150

Conditions

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

Eligibility

Sex: ALLMin age: 1 DayMax age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Time frame: 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)

Time frame: After 72 months from the study start

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