Non-Immunoglobulin E-mediated Food Allergies in Children

Recruiting

• Conditions: Non IgE Mediated Food Allergy; Food Protein-Induced Proctocolitis; Food Protein-Induced Enteropathy; Food Protein-Induced Enterocolitis Syndrome; Food Protein-induced Motility Disorders
• Interventions: Other: Non IgE-mediated food allergy

• Registration Number: NCT04462978
• Lead Sponsor: Federico II University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-08
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-11
• Primary Completion: 2023-12-30
• Study Completion: 2025-12-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non IgE-mediated food allergy	Non IgE-mediated food allergy	Children with non IgE-mediated food allergy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 mithocondrial metabolism of human lymphocytes
Evaluation of gut microbiome features in children with Non-IgE-mediated food allergies	through study completion, an average of 2 years	Evaluation of gut microbiome structure and function

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 Naples, Italy