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AGEs and Allergies in Children.

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ClinicalTrials.gov Identifier: NCT04273152
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University

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).

In Europe, around 17 million of people suffer from challenge-proven FA. If this prevalence is projected onto the world's population of seven billion, it translates into 63 million-1.16 billion of potential food-allergic people, with a greater incidence in children (5-8%) than in adults (1-2%) (Fiocchi et al. 2010).

Food allergy derives from a breakdown of immune tolerance. Current knowledge suggests that 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 also exist in foods. AGEs are naturally present in uncooked animal-derived foods, and cooking results in the formation of new AGEs within these foods. In particular, grilling, broiling, roasting, searing, and frying propagate and accelerate new AGE formation. 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 per se, but also through their interaction with specific receptors (RAGE). AGEs are able to activate mast cells and stimulate the release of histamine. The continuous stimulation of mast cells 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.


Condition or disease Intervention/treatment
Allergy Diagnostic Test: advanced glycation endproducts reader

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Advanced Glycation Endproducts and Allergies in Children
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
children with allergy
children with allergies
Diagnostic Test: advanced glycation endproducts reader
advanced glycation endproducts reader

healthy control
healthy control (non allergic children)
Diagnostic Test: advanced glycation endproducts reader
advanced glycation endproducts reader




Primary Outcome Measures :
  1. The advanced glycation endproducts subcutaneous levels [ Time Frame: at baseline ]
    the advanced glycation endproductssubcutaneous levels in allergic children compared with healthy controls.


Secondary Outcome Measures :
  1. the correlation between advanced glycation endproducts subcutaneous levels and dietary habits [ Time Frame: at baseline ]
    the correlation between advanced glycation endproducts subcutaneous levels and dietary habits



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. Written informed consent will be obtained from the parents/tutors of each subject. 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.
Criteria

Inclusion Criteria:

  • Caucasian ethnicity
  • Both sexes
  • Age ≥ 6 and ≤12 years with confirmed diagnosis of allergy (food and/or respiratory), and healthy controls age- and sex-matched.

Exclusion Criteria:

  • Non caucasian ethnicity
  • Age <6 or >12 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04273152


Locations
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Italy
Pediatric Office Recruiting
Naples, Italy, 80100
Contact: Roberto Berni Canani, MD, Ph    00390817462680    berni@unina.it   
Sponsors and Collaborators
Federico II University
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Responsible Party: Roberto Berni Canani, Professor, Federico II University
ClinicalTrials.gov Identifier: NCT04273152    
Other Study ID Numbers: 176/19
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases