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

Completed

Conditions: allergies
hooikoorts
10001708

Registration Number: NL-OMON40212

Lead Sponsor: Martini Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

- 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)

Exclusion Criteria

- 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)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Comparison of the (potential) differences in extracellular vesicle content and<br /><br>function between allergic and non-allergic mothers. In this exploratory study<br /><br>many state of the art techniques will be used, including multiplex assays<br /><br>(targeted protein assays), proteomics (untargeted protein analysis), western<br /><br>blot, high resolution flow cytometry, RNA analysis. The main endpoint of the<br /><br>study would be the identification of a difference in human milk extracellular<br /><br>vesicle content between allergic and non-allergic mothers with the potential to<br /><br>be developed into a biomarker for maternal allergy status, for predicting atopy<br /><br>development in the offspring, and/or for assessing the efficiency of<br /><br>anti-allergic therapies to preventatopy development in the offspring.</p><br>

Secondary Outcome Measures