Non-Immunoglobulin E-mediated Food Allergies in Children (NIGEFA)

Federico II University

Status: Enrolling

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

Treatments: Other: Non IgE-mediated food allergy

Study type: Observational

Funder types: Other

Identifiers

NCT04462978

102/20

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 1 day to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Non IgE-mediated food allergy

Description:

Children with non IgE-mediated food allergy

Treatment:

Other: Non IgE-mediated food allergy