Potential Role of AGEs in Paediatric Allergies

NCT04273152 | Completed

• 1 other identifier: 176/19
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Food allergy (FA) is "an adverse health effect arising from a specific immune response that occurs reproducibly" according to the 2010 National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIAID/NIH)-supported Guidelines for the Diagnosis and Management of Food Allergy in the United States (Boyce et al. 2010). Studies have suggested that the natural history of FA has changed during the last two decades, with a dramatic rise in the prevalence, severity of clinical manifestations, and risk of persistence into later ages, leading to an increase in hospital admissions, medical visits, treatments, and burden of care on families and to an important economic impact, with significant direct costs for the families and healthcare system (Skripak et al. 2007; McBride et al. 2012; Gupta et al. 2013). The development of FA might be influenced by genetics, environment, and genome-environment interactions, leading to immune system dysfunction, mediated at least in part by epigenetic mechanisms (Berni Canani et al. 2015; Paparo et al. 2018). Many factors have been postulated to contribute to the onset of FA. Among dietary factors, it has been hypothesized that advanced glycation endproducts (AGEs), present at high level in junk food, could be involved in FA pathogenesis. AGEs are a heterogeneous group of compounds deriving from a non-enzymatic reaction between reducing sugars and free amino groups of proteins, lipids, or nucleic acids. This reaction is also known as the Maillard or browning reaction. The formation of AGEs is a part of normal metabolism, but if excessively high levels of AGEs are reached in tissues and the circulation they can become pathogenic. AGEs are naturally present in uncooked animal-derived foods, and cooking results in the formation of new AGEs within these foods. Consumption of AGE-rich diets is associated with elevated circulating and tissue AGEs and an increase of their pro-inflammatory and pro-oxidant effects. On the other hand, restriction of AGEs prevents inflammation. AGEs not only exert their deleterious actions due to their biological properties, but also through their interaction with specific receptors (RAGE). AGEs are able to activate mast cells and induces a chronic inflammatory state that promotes a Th2 type response. The aim of this study is to evaluate the AGEs levels in FA children compared with healthy controls and subjects with other allergic diseases.

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

• The advanced glycation endproducts subcutaneous levels

  the advanced glycation endproductssubcutaneous levels in allergic children compared with healthy controls.

  at baseline

Secondary Outcomes (2)

• the correlation between advanced glycation endproducts subcutaneous levels and dietary habits

  at baseline

• the investigation of the potential pathogenetic role elicited by AGEs in allergy

  at baseline

Study Arms (2)

children with allergy

children with allergies

Diagnostic Test: advanced glycation endproducts reader

healthy control

healthy control (non allergic children)

Diagnostic Test: advanced glycation endproducts reader

Interventions

advanced glycation endproducts reader DIAGNOSTIC_TEST

advanced glycation endproducts reader

children with allergy; healthy control

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with confirmed diagnosis of allergy and healthy controls consecutively observed at our tertiary center for pediatric allergy will be evaluated for inclusion in the study. Only subjects who will meet the inclusion criteria will be invited to participate in the study. Anamnestic, demographic, anthropometric, and clinical data, as well as information on use of drugs, pre-, pro- or symbiotic products will be collected. Also dietary habits will be evaluated, particularly number, place and time of meals, special diets or elimination diets, frequency of consumption of cereals and derivatives, meat products, fish, eggs, dairy products, fruit and vegetables, legumes, sweets, sweetened beverages and possibly alcoholic drinks and the corresponding cooking methods.

You may qualify if:

• Caucasian ethnicity
• Both sexes
• Age ≥ 5 and ≤15 years with confirmed diagnosis of allergy (food and/or respiratory), and healthy controls age- and sex-matched.

You may not qualify if:

• Non caucasian ethnicity
• Age \<5 or \>15 years
• Concomitant presence of other chronic diseases not related to allergy (i.e., malignancy, immunodeficiency, cystic fibrosis, celiac disease, autoimmune diseases, neuropsychiatric diseases, diabetes mellitus type 1, chronic inflammatory bowel diseases, malformations of the urinary tract, gastrointestinal tract and/or respiratory tract, genetic-metabolic disorders, nervous system diseases, delayed psychomotor development, chronic lung diseases, hematological diseases)
• Presence of tattoos, scars, moles or lesions on both forearms

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Pediatric Office

Naples, 80100, Italy

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 17, 2020
• Study Start: January 1, 2018
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: October 11, 2021

Record last verified: 2021-10

Locations

IT (1)