Non-Immunoglobulin E-mediated Food Allergies in Children

Food Protein-Induced Enterocolitis Syndrome Clinical Trial

— NIGEFA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04462978
• Other study ID #: 102/20
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: December 28, 2025

Study information

• Verified date: March 2022
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 28, 2025
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Food Hypersensitivity
• Food Protein-Induced Enterocolitis Syndrome
• Hypersensitivity
• Intestinal Diseases
• Proctocolitis

Intervention

Other:
• Non IgE-mediated food allergy

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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