Primary: Evaluate whether quantification of functional IgE on basophils of food allergic patients can omit the need for food challenge tests to diagnose severity and threshold of the allergic reaction. Secondary: Evaluate whether numbers of…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
: The main study parameter is the detection of allergen-specific IgE, either
soluble in plasma or on the cell surface of immune cells. Allergic
sensitization will be defined as detection of IgE concentrations above the 95th
percentile of that detected in unaffected controls.
Secondary outcome
NA
Background summary
Food allergies are a major health concern with about 6-8% of children Western
countries affected. Food allergies are associated with a risk of severe
reactions (anaphylaxis) to common ingredients (peanut, cow*s milk, egg and
nuts), having a great impact on quality of life of children and their families.
There is a lack of practicable precision diagnostics, and therefore children
need to undergo an oral food challenge test, which has a risk of severe
reactions.
Study objective
Primary: Evaluate whether quantification of functional IgE on basophils of food
allergic patients can omit the need for food challenge tests to diagnose
severity and threshold of the allergic reaction. Secondary: Evaluate whether
numbers of immunophenotypes of allergen-specific B- and T-cells predict the
severity and/or threshold of the allergic reaction.
Study design
This is an observations study into which children (2-18 yr) are recruited with
a diagnosis of allergy. All recruits will be asked to donate 9-18mL of venous
blood for laboratory analysis. In addition, they will be asked to share basic
demographics (age, sex); details of allergic responses and current medication
use will be obtained from their medical records.
Study burden and risks
There is no perceived risk to the participants, investigators or institution.
Participants are having an additional 9-18 mL of blood sample taken along with
routine care. All blood sampling will follow Good Clinical Practice.
This research will not provide a direct therapeutic benefit to the participant.
However, we hope it will contribute by improving diagnosis, monitoring and
treatment of allergies in the future. The project will aid in identifying
potential biomarkers of allergy and treatment options. This project will have
positive impacts in the field of Allergy by potentially improving patient
diagnosis and treatment.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Aged 2-18 years
- Provided written informed consent
Exclusion criteria
- Under systemic immunosuppressive treatment
- History of hematological malignancy, immunodeficiency or autoimmune disease
- Active 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 | NL86818.078.24 |