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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

Tracking Information
First Submitted Date February 14, 2020
First Posted Date February 17, 2020
Last Update Posted Date February 17, 2020
Actual Study Start Date January 1, 2018
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 14, 2020)
The advanced glycation endproducts subcutaneous levels [ Time Frame: at baseline ]
the advanced glycation endproductssubcutaneous levels in allergic children compared with healthy controls.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 14, 2020)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title AGEs and Allergies in Children.
Official Title Advanced Glycation Endproducts and Allergies in Children
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Allergy
Intervention Diagnostic Test: advanced glycation endproducts reader
advanced glycation endproducts reader
Study Groups/Cohorts
  • children with allergy
    children with allergies
    Intervention: Diagnostic Test: advanced glycation endproducts reader
  • healthy control
    healthy control (non allergic children)
    Intervention: Diagnostic Test: advanced glycation endproducts reader
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 14, 2020)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 30, 2020
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04273152
Other Study ID Numbers 176/19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Roberto Berni Canani, Federico II University
Study Sponsor Federico II University
Collaborators Not Provided
Investigators Not Provided
PRS Account Federico II University
Verification Date February 2020