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

Investigating Clinical Features, Natural Course and Pathophysiology of Non-Immunoglobulin E-mediated Food Allergies in the Pediatric Age

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.

Study Overview

• 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
• Intervention / Treatment: Other: Non IgE-mediated food allergy

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • University of Naples Federico II
    • Contact: Roberto Berni Canani, MD, PhD; Phone Number: +390817462680

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non IgE-mediated food allergy; Children with non IgE-mediated food allergy	Other: Non IgE-mediated food allergy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 28, 2025

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Food allergy; Immune tolerance; Atopy patch test; Atopic march; Oral food challenge; Adverse food reactions; Food Protein-Induced Enteropathy; Food Protein-Induced Proctocolitis; Food Protein-Induced Enterocolitis Syndrome; Food protein-induced motility disorders
• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Rectal Diseases; Colitis; Sigmoid Diseases; Proctitis; Hypersensitivity; Enterocolitis; Intestinal Diseases; Food Hypersensitivity; Proctocolitis
• Other Study ID Numbers: 102/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No