Comparison of human milk extracellular vesicles in allergic and non-allergic mothers - ACCESS

Martini Ziekenhuis0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•- Age 18 years or above
•- The infant that is subject of breastfeeding was born term (gestational age 37-42 weeks) via vaginal delivery
•- Breastfeeding started from birth onwards;Inclusion criteria specific for the allergic donor group:
•- Established perennial or seasonal allergies against common inhalant or environmental allergens (e.g. house dust mite, pet allergens, pollen etc.)
•- Total serum IgE * 50 kU/L OR specific IgE detected by positive Phadiatop assay;Inclusion criteria specific for the non-allergic donor group:
•- No history and symptoms of allergy
•- Total serum IgE: <50kU/L and negative Phadiatop analysis at screening.
•- Absence of any atopy related condition, including diagnosed allergic asthma (defined as using any medication for asthma treatment) and diagnosed atopic dermatitis (defined as using any medication for atopic dermatitis treatment)

•- Use of systemic immunosuppressive or immunomodulatory medication, e.g. systemic corticosteroids (including use for treatment of severe asthma or atopic dermatitis), immunomodulatory biologicals, chemotherapeutics, use of NSAIDs in the week before inclusion / milk donation.
•- Altered immune function ( see protocol for list)

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