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ID
Source
Brief title
Health condition
Food allergy
Sponsors and support
Wetenschapsinstituut Martini Ziekenhuis
Intervention
Outcome measures
Primary outcome
The association of the occurrence of allergic symptoms during DBPCFC and biomarkers in saliva.
Secondary outcome
In case there is an association, we will investigate if biomarkers can be used as a predictor for the DBPCFC outcome.
Background summary
There is increasing attention for improvement of diagnosing food allergy. Until now, the double-blind placebo controlled food challenge (DBPCFC) is seen as the gold standard to establish or exclude the diagnosis of food allergy. The reported symptoms are used to conclude whether the food challenge was positive (i.e. food allergy confirmed), negative or inconclusive. It can be difficult to draw firm conclusions especially if subjective symptoms such as abdominal discomfort occur or if adverse reactions take place during placebo administration. Furthermore, the DBPCFC conclusion is subject to individual interpretation. Due to these limitations, it would be valuable to have additional objective criteria or biomarkers available to interpret the induced symptoms.
To study biomarkers associated with allergic reactions in children, it will be desirable to use noninvasive diagnostic methods, especially if serial assessments are needed. Salivary biomarkers could improve the diagnostic process of food allergy, yet results are still conflicting. Ideally, the potential release of specific allergic mediators can be used to determine objectively whether one has an allergy or not. Therefore, we aim to investigate the association between the occurrence of symptoms during DBPCFC and biomarkers in saliva.
Study objective
We hypothesise that during the food challenge, a quick and dose dependent increase in mast cell markers may occur, which will not happen at the placebo day.
Study design
Prior to, during and following DBPCFC, saliva will be collected. The minimum amount of saliva samples collected from each child is seven and the expected maximum is fourteen samples. Samples will be collected at both food challenge days (placebo and verum) in a time period of several hours depending whether symptoms develop or not.
Inclusion criteria
Children aged 6-18 years who visit our paediatric allergy centre of the Martini Hospital and who are recommended to perform a DBPCFC for peanut or tree nut as part of standard clinical care.
Exclusion criteria
- children younger than the age of six years
- DBPCFCs that had an inconclusive outcome
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL8890 |
Other | MEC Martini Ziekenhuis Groningen : 2020-026 |