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

Food Hypersensitivity Clinical Trial

— TRACEextension  

Official title:

Mechanisms Underlying the Change in Threshold or Severity of Peanut-allergic Reactions in TRACE Peanut Study Participants - Extension Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665793
• Other study ID #: 15SM2445 vs4.1 27.12.2015
• Secondary ID: FP7-KBBE 312147
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: May 19, 2017

Study information

• Verified date: October 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 19, 2017
• Est. primary completion date: May 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Hypersensitivity
• Hypersensitivity
• Peanut Hypersensitivity

Intervention

Other:
• DBPCFC to peanut cookie

• Single-dose DBPCFC to peanut flour
Single-dose DBPCFC to peanut in a water-continuous matrix, at a cumulative dose one dosing level below that individual's threshold (established at the baseline challenge). If no reaction is seen, participants will be given the next dosing level.
• Single-dose DBPCFC to peanut butter
Single-dose DBPCFC to peanut in a water-continuous matrix, at a cumulative dose one dosing level below that individual's threshold (established at the baseline challenge). If no reaction is seen, participants will be given the next dosing level.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Imperial College London	Cambridge University Hospitals NHS Foundation Trust, Food Standards Agency, United Kingdom, University of Manchester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum eliciting dose	Minimum eliciting dose of peanut to trigger an objective allergic reaction according to international consensus criteria (PRACTALL))	2 hours
Secondary	Symptom pattern	Symptoms experienced following peanut challenge (defined according to international consensus criteria (PRACTALL) )	12 hours

External Links

•   iFAAM website