Peanut allergy T78.1
Conditions
Interventions
Group 1: Children and adolescents with challenge proven peanut allergy.
Blood is drawn from the subjects prior and at several time points after oral peanut food challenge.
In addition, a questionna
Sponsors
Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Pneumologie, Allergologie, Infektiologie, Gastroenterologie
Eligibility
Sex/Gender
All
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria of peanut allergic patients/ of peanut-sensitized but tolerant patients: -Completion of the whole procedure of an oral peanut challenge according to the standard operation procedure for suspected peanut allergy of the Department of Pediatrics , Division of Pneumology, Allergology, Infectious diseases and Gastroenterology of the University Hospital Frankfurt - challenge positive for peanut allergic patients (showing an objective systemic allergic reaction to peanut at challenge meeting )/ challenge negative for peanut-sensitized but tolerant patients (without an allergic reaction to peanut) - Peanut-specific IgE >0.35k U/l and/or = 3 mm peanut wheal size in prick test,(this information within medical history, these are mandatory values, which have to be performed up to six month prior DBPCFC) - Presence of informed consent from legal guardians and, in the case of adolescents, additionally own patient assent Inclusion criteria of peanut allergic patients tested before and after oral challenge at different time points for establishing kinetics - Age: = 4 years to 17 years (age restrictions due to volume of blood samples needed) - Completion of the whole procedure of an oral peanut challenge according to the standard operation procedure for suspected peanut allergy of the Department of Pediatrics , Division of Pneumology, Allergology, Infectious diseases and Gastroenterology of the University Hospital Frankfurt - challenge positive (showing an objective allergic reaction to peanut at challenge meeting stopping criteria for challenges as defined by Blumchen et al. (4) - patients with mild to moderate systemic anaphylactic allergic reaction after oral challenge defined as occurrence of two or more symptoms in different organ systems like involvement of the skin-mucosal tissue (eg, generalized hives, itch-flush, swollen lips-tongue-uvula), of the respiratory system (eg, dry continuous cough, dyspnea, wheeze-bronchospasm, stridor), of the gastrointestinal tract (crampy abdominal pain, vomiting) - Peanut-specific IgE >0.35k U/l and/or = 3 mm peanut wheal size in prick test,(this information within medical history, these are mandatory values, which have to be performed up to six month prior DBPCFC) - Presence of informed consent from legal guardians and, in the case of adolescents, additionally own patient assent Inclusion criteria of healthy subjects: - Age: =2 years to 17 years (age restriction due to volume of blood samples needed) - Healthy, infection-free- patients admitted for elective surgery (e.g., for inguinal hernia, circumcision, orchidopexy, dermoid cyst, hypospadias, vesicourethral reflux) - Patients with regular peanut consumption (mandatory: up to six month before elective surgery) and without allergic reaction after peanut consumption - Presence of informed consent from legal guardians and, in the case of adolescents, additionally own patient assent
Exclusion criteria
Exclusion criteria: Exclusion criteria for peanut allergic and peanut-sensitized but tolerant patient groups: - All exclusion criteria for performing an oral food challenge, (e.g. acute infection, non-stable comorbidity like asthma, atopic dermatitis - Overweight (BMI =90th percentile) Exclusion criteria of healthy subjects: - Overweight (BMI =90th percentile) - Doctor´s diagnosis of allergic diseases like bronchial asthma, atopic dermatitis, allergic rhinokonjunctivitis, food allergy, chronic urticaria - Doctor´s diagnosis of chronic inflammatory gastrointestinal diseases and unspecific abdominal symptoms - Family history of atopic diseases (first degree relative suffering from asthma, food allergy, atopic dermatitis; allergic rhinoconjunctivitis) - Peanut-specific IgE >0.35k U/l - sensitization to common aeroallergens and food allergens (IgE- sx1(includes the following allergens like birch, timothy grass, mugwort, house dust mite (Dermatophagoides pteronyssinus), cat dander, dog dander and mold (Cladosporium herbarum) =0.35kU/l and/or IgE-fx5 (cow’s milk, hen’s egg, cod, soy, wheat and peanut) =0.35kU/l)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterization of a specific miRNA profile of peanut allergic children/adolescents with a significant difference to healthy and to sensitized but tolerant children/ adolescents. | — |
Secondary
| Measure | Time frame |
|---|---|
| Characterization of a specifically altered miRNA profile intraindividually before and after DBPCFC in peanut allergic children showing mild to moderate systemic anaphylactic allergic reactions at challenge. Correlation of potential miRNA expressions, peanut-sIgE, tryptase and PGF 2 levels at baseline with the clinical severity of the allergic reaction and the reaction dose (threshold) at oral peanut challenge. Correlation of potential changes in miRNA expression, tryptase and PGF 2 levels during any objective systemic allergic reaction at challenge and these candidates at baseline with the severity of the allergic reaction and the reaction dose at oral food challenges. | — |
Countries
Germany
Outcome results
None listed