Non-Immunoglobulin E-mediated Food Allergies in Children

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.

Full Title of Study: “Investigating Clinical Features, Natural Course and Pathophysiology of Non-Immunoglobulin E-mediated Food Allergies in the Pediatric Age”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 30, 2023

Interventions

  • Other: Non IgE-mediated food allergy

Arms, Groups and Cohorts

  • Non IgE-mediated food allergy
    • Children with non IgE-mediated food allergy

Clinical Trial Outcome Measures

Primary Measures

  • Evaluation of clinical features and disease course of non-IgE mediated food allergies in children
    • Time Frame: After 72 months from the study start
    • 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
  • Evaluation of clinical features of non-IgE mediated food allergies in children
    • Time Frame: After 72 months from the study start
    • Dietary management and Nutritional status (weight and height will be combined to report BMI z-score)

Secondary Measures

  • Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
    • Time Frame: through study completion, an average of 2 years
    • Evaluation of serum levels of Th2, Th1, and Th17 cytokines
  • Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
    • Time Frame: through study completion, an average of 2 years
    • Evaluation of epigenetic mechanisms
  • Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
    • Time Frame: through study completion, an average of 2 years
    • Evaluation of immune cells phenotype
  • Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
    • Time Frame: through study completion, an average of 2 years
    • Evaluation of mithocondrial metabolism of human lymphocytes
  • Evaluation of gut microbiome features in children with Non-IgE-mediated food allergies
    • Time Frame: through study completion, an average of 2 years
    • Evaluation of gut microbiome structure and function

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 14 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Federico II University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Roberto Berni Canani, MD, PhD, Professor of Pediatrics – Federico II University

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