Non-Immunoglobulin E-mediated Food Allergies in Children

NCT04462978 | Unknown DMC

• 1 other identifier: 102/20
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  After 72 months from the study start

Secondary Outcomes (5)

• Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children

  through study completion, an average of 2 years

• Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children

  through study completion, an average of 2 years

• Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children

  through study completion, an average of 2 years

• Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children

  through study completion, an average of 2 years

• Evaluation of gut microbiome features in children with Non-IgE-mediated food allergies

  through study completion, an average of 2 years

Study Arms (1)

Non IgE-mediated food allergy

Children with non IgE-mediated food allergy

Other: Non IgE-mediated food allergy

Interventions

Non IgE-mediated food allergy OTHER

Non IgE-mediated food allergy

Eligibility Criteria

• Age: 1 Day - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• subjects aged between 0-14 years
• suggestive history of food allergy

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples Peripheral blood samples

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: July 8, 2020
• Study Start: January 1, 2017
• Primary Completion: December 30, 2023
• Study Completion: December 28, 2025
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

IT (1)