Clinical trial NCT04462978: Non-Immunoglobulin E-mediated Food Allergies in Children
Official title: Investigating Clinical Features, Natural Course and Pathophysiology of Non-Immunoglobulin E-mediated Food Allergies in the Pediatric Age
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non IgE Mediated Food Allergy
Food Protein-Induced Enteropathy
Food Protein-Induced Proctocolitis
Food Protein-Induced Enterocolitis Syndrome
Food Protein-induced Motility Disorders
Keywords: Food allergy
Adverse food reactions
Immune tolerance
Atopy patch test
Atopic march
Oral food challenge
Food Protein-Induced Enteropathy
Food Protein-Induced Proctocolitis
Food Protein-Induced Enterocolitis Syndrome
Food protein-induced motility disorders
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

Brief 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

Primary outcomes:
measure: Evaluation of clinical features and disease course of non-IgE mediated food allergies in children
timeFrame: After 72 months from the study start
measure: Evaluation of clinical features of non-IgE mediated food allergies in children
timeFrame: After 72 months from the study start
Secondary outcomes:
measure: Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
timeFrame: through study completion, an average of 2 years
measure: Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
timeFrame: through study completion, an average of 2 years
measure: Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
timeFrame: through study completion, an average of 2 years
measure: Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
timeFrame: through study completion, an average of 2 years
measure: Evaluation of gut microbiome features in children with Non-IgE-mediated food allergies
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References: