Clinical trial NCT02665793: Mechanisms Underlying Peanut Allergic Reactions in TRACE Peanut Study Participants: Extension Study
Official title: Mechanisms Underlying the Change in Threshold or Severity of Peanut-allergic Reactions in TRACE Peanut Study Participants - Extension Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Hypersensitivity
Peanut Hypersensitivity
Keywords: Peanut allergy
Food allergy
Thresholds
Anaphylaxis
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: University of Manchester
name: Food Standards Agency, United Kingdom
name: Cambridge University Hospitals NHS Foundation Trust
First posted: 2016-01-28
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Written informed consent.
* Male and female participants in the TRACE study (NCT01429896) who are 18-45 years of age at the time of entry to the TRACE study (Visit 1) and had a positive DBPCFC to peanut at baseline (Visit 1).

Exclusion criteria

* unable to comply with study procedures

Primary outcomes:
measure: Minimum eliciting dose
timeFrame: 2 hours
Secondary outcomes:
measure: Symptom pattern
timeFrame: 12 hours
Other outcomes:
Locations:
Study officials:
affiliation: University of Manchester
name: Clare Mills, PhD
role: STUDY_CHAIR
References:
citation: Turner PJ, Ruiz-Garcia M, Patel N, Abrantes G, Burrell S, Vazquez-Ortiz M, Skypala I, Durham SR, Boyle RJ. Delayed symptoms and orthostatic intolerance following peanut challenge. Clin Exp Allergy. 2021 May;51(5):696-702. doi: 10.1111/cea.13865. Epub 2021 Mar 21.