To understand the development of immunological tolerance for allergens in young children.
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Development in time of number, phenotype and function of several subsets of
mononuclear cells with special attention for T regulatory cells. Levels and
effect of immune modulating factors such as adenosine, PGE2 and innate stimuli
on the function of immune cells over time.
Secondary outcome
Not applicable
Background summary
There has been a clear and worrying increase in a diverse range of allergic
diseases, such as asthma, eczema, food allergy and hay fever, which are all
associated with an underlying failure of immune tolerance to allergens.
Development of immune tolerance is a critical process in early life and seems
to be influenced by external factors such as infections, gut colonization and
nutritional immune modulating factors. The mechanisms of immunological
tolerance induction in young children are largely unknown. A better insight in
these processes and the external factors that influence them is needed to be
able to develop treatment strategies aiming at the prevention of allergic
disease in high risk children.
Study objective
To understand the development of immunological tolerance for allergens in young
children.
Study design
Cord blood and blood at one or several time points during the first year of
life will be obtained from *immunologically healthy* children. Peripheral Blood
Mononuclear Cells (PBMC) and serum will be isolated and cellular and humoral
immune factors hypothesized to be important in the induction of immune
tolerance will be studied. At each time point questionnaires will be taken to
obtain information about family history for allergic disease and the allergic
status of the child at time of blood draw. At the day of the first surgical
intervention 30 ml blood will be drawn from the mother as well.
Study burden and risks
Risks and burden for the subjects are related to blood withdrawals only and
brought to a minimum. The blood withdrawals occur under general anaesthesia
before surgery and will be executed by experienced professionals. The number of
blood withdrawals depends on the number of surgical interventions, with a
maximum of 4 blood withdrawals and 10 ml per withdrawal (in one year). The
participants will not directly benefit from the outcome of the study.
PO Box 85090
3508 AB
NL
PO Box 85090
3508 AB
NL
Listed location countries
Age
Inclusion criteria
- antanatal diagnosed birthdefect such as schizis, duodenal atresia or orthopedic problems
- uncomplicated pregnancy and delivery
- birth planned in UMCU/WKZ
- a term delivery
- availability of cordblood
- one or more times surgery in the first year of life
Exclusion criteria
Complications during pregnancy (HELPP, infection)
Use of immune modulating medication during pregnancy
Smoking during pregnancy
Perinatal complications
- Prematurity (<36 weeks) or dysmaturity (birthweight - Use of antibiotics by the mother in the two weeks before delivery
- Use of antibiotics by the child in the first two weeks of life
- Immunological disorders such as VCF, DiGeorge
- Chromosomal disorder
- Perinatal infection
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 | NL24493.041.08 |