Impacts of Nitrogen Deposition in the Natural Environment on Pollen Allergy in Belgium

Обзор

The investigators want to study the effect of environmental nitrogen enrichment on the allergy burden in pollen-sensitized subjects.

Подробное описание

The investigators want to study allergen-specific IgE reactivity from a cross-sectional sample of pollen-allergic patients (and negative controls) against environmental and experimental pollen samples. Following aspects will be compared:

* To study the basophil degranulation with different amounts of pollen on fresh patient-derived basophils, to determine the concentration of pollen needed to degranulate 5% (EC5), and 50% (EC50) of basophils. * To study he overall intensity (quantitative), as well as IgE-mediated hyper- or hyporecognition of different fragments in the pollen samples (qualitative) in a subset of patients. * To associate allergic rhinoconjunctivitis and food-pollen syndrome related symptoms with reactivity to different pollen samples.

Вмешательства

• Диагностический тест Immunoreactivity testing
  Blood samples will be collected and used to determine the intensity of the allergenicity of the subject toward different types of pollen. This will be done by the detection of sIgE antibodies to the pollen extracts and basophil activation testing (BAT) with pollen extracts.
• Диагностический тест Immunoreactivity testing (negative control)
  Blood samples will be collected and used to determine the background activity of our immunoreactivity tests. The investigators will use samples from negative controls to demonstrate that non-allergic individuals do not react to our assays, confirming that our pollen extracts have no background reactivity. This will be done by the detection of sIgE antibodies to the pollen extracts and basophil activation testing (BAT) with pollen extracts.

Первичные конечные точки

• Specific IgE reactivity (in-house developed) against environmental and experimental pollen samples [Срок оценки: From time of inclusion to 12 months]

Вторичные конечные точки (3)

• Basophil degranulation with different amounts of pollen on fresh patient-derived basophils. [Срок оценки: From time of inclusion to 12 months]
• Overall intensity (quantitative) of IgE reactivity to pollen samples in a subset of patients. [Срок оценки: From time of inclusion to 12 months]
• IgE-mediated hyper- or hyporecognition of different fragments in the pollen samples (qualitative) in a subset of patients. [Срок оценки: From time of inclusion to 12 months]

Критерии участия

Критерии включения

• Positive skin prick test for grass and/or birch pollen

Критерии исключения

• Desensitization therapy during the last two years

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Бельгия · 1 центр

• University Hospitals Leuven — Leuven

Публикации

• Verscheure P, Honnay O, Speybroeck N, Daelemans R, Bruffaerts N, Devleesschauwer B, Ceulemans T, Van Gerven L, Aerts R, Schrijvers R. Impact of environmental nitrogen pollution on pollen allergy: A scoping review. Sci Total Environ. 2023 Oct 1;893:164801. doi: 10.1016/j.scitotenv.2023.164801. Epub 2023 Jun 14. PMID 37321510
• Ceulemans T, Verscheure P, Shadouh C, Van Acker K, Devleesschauwer B, Linard C, Dendoncker N, Speybroeck N, Bruffaerts N, Honnay O, Schrijvers R, Aerts R. Environmental degradation and the increasing burden of allergic disease: The need to determine the impact of nitrogen pollution. Front Allergy. 2023 Feb 2;4:1063982. doi: 10.3389/falgy.2023.1063982. eCollection 2023. No abstract available. PMID 36819832

Идентификаторы

NCT: NCT06714149 · S65184 · B2/212/P1/NITROPOL-BE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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