Mechanisms Underlying Peanut Allergic Reactions in TRACE Peanut Study Participants: Extension Study

Not Applicable

Completed

• Conditions: Peanut Hypersensitivity; Food Hypersensitivity
• Interventions: Other: DBPCFC to peanut cookie; Other: Single-dose DBPCFC to peanut flour; Other: Single-dose DBPCFC to peanut butter

• Registration Number: NCT02665793
• Lead Sponsor: Imperial College London

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-01-28
• Study Start: 2016-08
• Primary Completion: 2017-05-19
• Study Completion: 2017-05-19
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-19
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DBPCFC to peanut cookie, then single-dose DBPCFC x 2	Single-dose DBPCFC to peanut flour	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
Single dose DBPCFC x 2, then DBPCFC to peanut cookie	Single-dose DBPCFC to peanut flour	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
Single dose DBPCFC x 2, then DBPCFC to peanut cookie	Single-dose DBPCFC to peanut butter	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
DBPCFC to peanut cookie, then single-dose DBPCFC x 2	DBPCFC to peanut cookie	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
DBPCFC to peanut cookie, then single-dose DBPCFC x 2	Single-dose DBPCFC to peanut butter	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
Single dose DBPCFC x 2, then DBPCFC to peanut cookie	DBPCFC to peanut cookie	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

Primary Outcome Measures

Name	Time	Method
Minimum eliciting dose	2 hours	Minimum eliciting dose of peanut to trigger an objective allergic reaction according to international consensus criteria (PRACTALL))

Secondary Outcome Measures

Name	Time	Method
Symptom pattern	12 hours	Symptoms experienced following peanut challenge (defined according to international consensus criteria (PRACTALL) )