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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40212

Enrollment

Registered

2014-07-21

Start date

2014-10-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergies hooikoorts

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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:

Exclusion criteria

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)

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results