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

NCT02665793 | Completed DMC

• 2 other identifiers: 15SM2445 vs4.1 27.12.2015FP7-KBBE 312147
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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. 1.incremental doses of peanut in a water-continuous matrix;
2. 2.incremental doses of peanut baked into a cookie biscuit;
3. 3.a single dose of peanut in a water-continuous matrix.

Conditions

Food Hypersensitivity; Peanut Hypersensitivity

Keywords

Peanut allergy; Food allergy; Thresholds; Anaphylaxis

Outcome Measures

Primary Outcomes (1)

• Minimum eliciting dose

  Minimum eliciting dose of peanut to trigger an objective allergic reaction according to international consensus criteria (PRACTALL))

  2 hours

Secondary Outcomes (1)

• Symptom pattern

  12 hours

Study Arms (2)

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

EXPERIMENTAL

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

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

Single dose DBPCFC x 2, then DBPCFC to peanut cookie

EXPERIMENTAL

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

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

Interventions

DBPCFC to peanut cookie OTHER

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

Single-dose DBPCFC to peanut flour OTHER

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.

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

Single-dose DBPCFC to peanut butter OTHER

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.

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• unable to comply with study procedures

Sponsors & Collaborators

• Imperial College London: lead
• University of Manchester: collaborator
• Food Standards Agency, United Kingdom: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Related Publications (1)

• 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.

  PMID: 33715235 DERIVED

Related Links

• iFAAM website

MeSH Terms

Conditions

Food Hypersensitivity; Peanut Hypersensitivity; Anaphylaxis

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity

Study Officials

• Clare Mills, PhD

  University of Manchester

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist and Hon Consultant in Paediatric Allergy & Immunology

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: January 28, 2016
• Study Start: August 1, 2016
• Primary Completion: May 19, 2017
• Study Completion: May 19, 2017
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share