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Recruiting
NCT04462978
Non-Immunoglobulin E-mediated Food Allergies in Children
Conditions: Non IgE Mediated Food Allergy, Food Protein-Induced Enteropathy, Food Protein-Induced Proctocolitis, Food Protein-Induced Enterocolitis Syndrome, Food Protein-induced Motility Disorders
Sex: All
Ages: 1 Day – 14 Years
Healthy volunteers: Yes
Enrollment: 150
Sponsor: Federico II University
Location: University of Naples Federico II Naples
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 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
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
Source: ClinicalTrials.gov (NCT04462978). StuddyBuddy aggregates publicly available trial information.