To define differences in the molecular composition of human milk extracellular vesicles between allergic and non-allergic mothers. Additionally, other differences in human milk composition will be analyzed (cellularity, nutrient content,…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Not applicable
Background summary
It has been demonstrated that the maternal immune status influences the
composition of human milk and affects the onset of chronic immune-related
diseases, such as allergies, later on in the infant*s life. How human milk
actually influences the development of the infant*s immune system and chronic
diseases is not known. Human milk contains various immune-modulatory components
and has recently been shown to contain immune-modulatory extracellular
vesicles. These are nano-sized membrane vesicles of which the secretion, cargo
composition (including proteins and (micro)RNAs), and targeting is tightly
regulated. This has led to the hypothesis that extracellular vesicles are
tailor-made messengers for specific intercellular communication. Therefore,
human milk-derived extracellular vesicles could play a role in the maternal
imprinting and programming of the infant*s immune system via the
gastrointestinal tract. It has been described that children of allergic mothers
have a higher risk of developing allergic conditions. This exploratory study
will investigate the potential role of human milk extracellular vesicles in
this process by comparing the molecular composition of vesicles in milk from
allergic and non-allergic mothers. If differences are found, these can be used
as predictive/prognostic biomarkers and as potential targets for future
interventions. Since extracellular vesicles physically combine physiologically
relevant biological markers in a single vesicle, we expect that extracellular
vesicle-based biomarkers are a valuable extension of currently available
biomarkers.
Study objective
To define differences in the molecular composition of human milk extracellular
vesicles between allergic and non-allergic mothers. Additionally, other
differences in human milk composition will be analyzed (cellularity, nutrient
content, immunological and inflammatory markers) and outcomes will be linked to
atopy in the infants at 1 year of age.
Study design
exploratory observational study
Study burden and risks
There are no specific risks associated with participation in this observational
study. Obviously, due to the observational nature of this study, there is no
potential health benefit associated with participation either. The light burden
of the study procedures are balanced by the psycho-emotional benefit of
contributing to a study to increase the scientific knowledge on the
relationship between maternal allergy, human milk composition and atopy/allergy
development in the child.
VAn Swietenplein 1
Groningen 9728 NT
NL
VAn Swietenplein 1
Groningen 9728 NT
NL
Listed location countries
Age
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47426.099.14 |