Food Hypersensitivity Clinical Trial
Official title:
Mechanisms Underlying the Change in Threshold or Severity of Peanut-allergic Reactions in TRACE Peanut Study Participants - Extension Study
Food allergy affects up to 10% of the population. The mainstay of management involves dietary
avoidance and provision of rescue medication in the event of an accidental reaction. The
Integrated approaches to food allergen and allergy management (iFAAM) collaboration is an
EU-funded academic/clinical/industry consortium with the aim to improve allergen risk
management including food labelling. Much of this work requires the validation of the minimum
'eliciting dose' for the food-allergic population and how this can be translated into risk
management.
A number of studies (including iFAAM and the TRACE study - NCT01429896) have assessed the
eliciting dose for peanut allergic patients, using food challenges where peanut-allergic
individuals are eat incremental doses of peanut under strict medical supervision.
In this extension study, peanut-allergic subjects will have undergone (in a cross-over
manner) three double-blind, placebo-controlled food challenges to peanut:
1. incremental doses of peanut in a water-continuous matrix;
2. incremental doses of peanut baked into a cookie biscuit;
3. a single dose of peanut in a water-continuous matrix.
The differences in eliciting dose, symptom pattern and underlying physiological mechanisms
will provide essential data on how the presentation and consumption of peanut affects the
amount needed to trigger an allergic reaction, to inform industry and food regulators as to
how to best protect the food-allergic population.
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