AllergyNCT04273152
Potential Role of AGEs in Paediatric Allergies
An observational study of Allergy, run by Federico II University at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Allergy
- What is being tested?
- advanced glycation endproducts reader
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential Role of Advanced Glycation End-products in the Pathogenesis of Paediatric Allergies
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.
Read the detailed description
The study is designed to evaluate the AGEs concentration in allergic children compared with healthy controls and to investigate the potential role of AGEs in FA pathogenesis. First, the investigators will define subcutaneous AGEs levels in children affected by allergy, comparing to non-allergy children AGEs levels. Subsequently, the investigators will investigate the possible correlation with dietary habits and the potential effects of AGEs on gut barrier components and on non-immune and immune mechanisms in experimental models.
- Conditions
- Allergy
- Being tested
- advanced glycation endproducts reader
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
advanced glycation endproducts readerDiagnostic test
advanced glycation endproducts reader
| Study group | Role | What they receive |
|---|---|---|
| children with allergy | children with allergies Receives: Diagnostic Test: advanced glycation endproducts reader | |
| healthy control | healthy control (non allergic children) Receives: Diagnostic Test: advanced glycation endproducts reader |
What is being measured
The primary outcome is the main question the study is designed to answer.
The advanced glycation endproducts subcutaneous levels
the advanced glycation endproductssubcutaneous levels in allergic children compared with healthy controls.
Measured: at baseline
Secondary outcomes (2)
the correlation between advanced glycation endproducts subcutaneous levels and dietary habits
the correlation between advanced glycation endproducts subcutaneous levels and dietary habits
Measured: at baseline
the investigation of the potential pathogenetic role elicited by AGEs in allergy
- Intestinal permeability (using transepithelial eletrical resistence), tight junction proteins expression (measured as fold change), the epithelial cell-derived danger signal mediators IL-33 and TSLP (pg/ml), RAGE pathway expression (measured as fold change), ROS production (expressed as optical density) analysis on human enterocytes cell line
- IL-4, IL-5, IL-13, IL-10, IFN-g, IL-6, IL-8, TNF-a determination (pg/ml) on culture supernatants from peripheral blood mononuclear cells
- Immunohistochemistry analysis of small intestinal biopsies (measured as number of CD25+ mononuclear cells)
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Jan 2018
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273152
- Sponsor's protocol ID
- 176/19
- Status last verified
- Oct 2021
- First submitted
- 14 Feb 2020
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Paparo L, Coppola S, Nocerino R, Pisapia L, Picariello G, Cortese M, Voto L, Maglio M, Miele E, Carucci L, Oglio F, Trinchese G, Mollica MP, Bruno C, De Vita S, Tarallo A, Damiano C, Cerulo M, Esposito C, Fogliano V, Parenti G, Troncone R, Berni Canani R. How dietary advanced glycation end products could facilitate the occurrence of food allergy. J Allergy Clin Immunol. 2024 Mar;153(3):742-758. doi: 10.1016/j.jaci.2023.11.023. Epub 2023 Nov 30.
PubMed 38042501
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Role of Advanced Glycation End-products in the Pathogenesis of Paediatric Allergies
- ClinicalTrials.gov ID
- NCT04273152
- Acronym / sponsor ID
- 176/19
- Conditions
- Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is designed to evaluate the AGEs concentration in allergic children compared with healthy controls and to investigate the potential role of AGEs in FA pathogenesis. First, the investigators will define subcutaneous AGEs levels in children affected by allergy, comparing to non-allergy children AGEs levels. Subsequently, the investigators will investigate the possible correlation with dietary habits and the potential effects of AGEs on gut barrier components and on non-immune and immune mechanisms in experimental models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with allergy | – | Diagnostic Test: advanced glycation endproducts readerchildren with allergies |
| healthy control | – | Diagnostic Test: advanced glycation endproducts readerhealthy control (non allergic children) |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| advanced glycation endproducts readeradvanced glycation endproducts reader | Diagnostic test | children with allergy, healthy control |
Primary outcome
The advanced glycation endproducts subcutaneous levels
Time frame: at baseline
the advanced glycation endproductssubcutaneous levels in allergic children compared with healthy controls.
2 secondary outcomes
the correlation between advanced glycation endproducts subcutaneous levels and dietary habits
Time frame: at baseline
the investigation of the potential pathogenetic role elicited by AGEs in allergy
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Derived from this study: PubMed 38042501Paparo L, Coppola S, Nocerino R, Pisapia L, Picariello G, Cortese M, Voto L, Maglio M, Miele E, Carucci L, Oglio F, Trinchese G, Mollica MP, Bruno C, De Vita S, Tarallo A, Damiano C, Cerulo M, Esposito C, Fogliano V, Parenti G, Troncone R, Berni Canani R. How dietary advanced glycation end products could facilitate the occurrence of food allergy. J Allergy Clin Immunol. 2024 Mar;153(3):742-758. doi: 10.1016/j.jaci.2023.11.023. Epub 2023 Nov 30.
- Individual participant dataSharing planned: Undecided
Related trials for Allergy
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The advanced glycation endproducts subcutaneous levels (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04273152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.