Mechanisms Underlying Peanut Allergic Reactions in TRACE Peanut Study Participants: Extension Study (TRACEextension)

Imperial College London

Status: Completed

Conditions: Peanut Hypersensitivity; Food Hypersensitivity

Treatments: Other: Single-dose DBPCFC to peanut flour; Other: DBPCFC to peanut cookie; Other: Single-dose DBPCFC to peanut butter

Study type: Interventional

Funder types: Other

Identifiers

NCT02665793

15SM2445 vs4.1 27.12.2015

FP7-KBBE 312147 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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17 participants in 2 patient groups

DBPCFC to peanut cookie, then single-dose DBPCFC x 2

Experimental group

Description:

Patients will undergo 3 sets of double-blind, placebo-controlled food challenge (DBPCFC): 1. DBPCFC to incremental doses of peanut (or placebo) baked into a cookie biscuit 2. DBPCFC to a single dose of peanut (or placebo) equivalent to 1 dosing interval below that to which that patient reacted at the baseline DBPCFC to gain entry to the study, on two separate occasions

Treatment:

Other: Single-dose DBPCFC to peanut flour

Other: Single-dose DBPCFC to peanut butter

Other: DBPCFC to peanut cookie

Single dose DBPCFC x 2, then DBPCFC to peanut cookie

Experimental group

Description:

Patients will undergo 3 sets of double-blind, placebo-controlled food challenge (DBPCFC): 1. DBPCFC to a single dose of peanut (or placebo) equivalent to 1 dosing interval below that to which that patient reacted at the baseline DBPCFC to gain entry to the study, on two separate occasions 2. DBPCFC to incremental doses of peanut (or placebo) baked into a cookie biscuit

Treatment:

Other: Single-dose DBPCFC to peanut flour

Other: Single-dose DBPCFC to peanut butter

Other: DBPCFC to peanut cookie