Non-Immunoglobulin E-mediated Food Allergies in Children

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-14
SponsorFederico II University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

subjects aged between 0-14 years

suggestive history of food allergy

Disqualifiers

age >14 years-

chronic systemic diseases,

malignancy,

immunodeficiency,

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non IgE-mediated food allergy

    Other intervention

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Non IgE-mediated food allergy1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
After 72 months from the study start
2

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)

Time frame
After 72 months from the study start

Secondary outcomes

1

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

Time frame
through study completion, an average of 2 years
2

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

Evaluation of epigenetic mechanisms

Time frame
through study completion, an average of 2 years
3

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

Evaluation of immune cells phenotype

Time frame
through study completion, an average of 2 years
4

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

Evaluation of mithocondrial metabolism of human lymphocytes

Time frame
through study completion, an average of 2 years

Other outcomes

Sponsors and contacts

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