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

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

Sponsors

Lead Sponsor: Imperial College London

Collaborator: University of Manchester
Food Standards Agency, United Kingdom
Cambridge University Hospitals NHS Foundation Trust

Source 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.

Overall Status Completed
Start Date August 2016
Completion Date May 19, 2017
Primary Completion Date May 19, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Minimum eliciting dose 2 hours
Secondary Outcome
Measure Time Frame
Symptom pattern 12 hours
Enrollment 17
Condition
Intervention

Intervention Type: Other

Intervention Name: DBPCFC to peanut cookie

Intervention Type: Other

Intervention Name: Single-dose DBPCFC to peanut flour

Description: 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.

Intervention Type: Other

Intervention Name: Single-dose DBPCFC to peanut butter

Description: 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.

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Clare Mills, PhD Study Chair University of Manchester
Verification Date

October 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Imperial College London

Investigator Full Name: Paul Turner

Investigator Title: Clinician Scientist and Hon Consultant in Paediatric Allergy & Immunology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

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

Type: Experimental

Description: Patients will undergo 3 sets of double-blind, placebo-controlled food challenge (DBPCFC): DBPCFC to incremental doses of peanut (or placebo) baked into a cookie biscuit 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

Label: Single dose DBPCFC x 2, then DBPCFC to peanut cookie

Type: Experimental

Description: Patients will undergo 3 sets of double-blind, placebo-controlled food challenge (DBPCFC): 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 incremental doses of peanut (or placebo) baked into a cookie biscuit

Acronym TRACEextension
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Other

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov