search
Back to results

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

Primary Purpose

Food Hypersensitivity, Peanut Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DBPCFC to peanut cookie
Single-dose DBPCFC to peanut flour
Single-dose DBPCFC to peanut butter
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Food Hypersensitivity focused on measuring Peanut allergy, Food allergy, Thresholds, Anaphylaxis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

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

    Single dose DBPCFC x 2, then DBPCFC to peanut cookie

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Symptom pattern
    Symptoms experienced following peanut challenge (defined according to international consensus criteria (PRACTALL) )

    Full Information

    First Posted
    January 25, 2016
    Last Updated
    October 19, 2019
    Sponsor
    Imperial College London
    Collaborators
    University of Manchester, Food Standards Agency, United Kingdom, Cambridge University Hospitals NHS Foundation Trust
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02665793
    Brief Title
    Mechanisms Underlying Peanut Allergic Reactions in TRACE Peanut Study Participants: Extension Study
    Acronym
    TRACEextension
    Official Title
    Mechanisms Underlying the Change in Threshold or Severity of Peanut-allergic Reactions in TRACE Peanut Study Participants - Extension Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2016 (Actual)
    Primary Completion Date
    May 19, 2017 (Actual)
    Study Completion Date
    May 19, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Imperial College London
    Collaborators
    University of Manchester, Food Standards Agency, United Kingdom, Cambridge University Hospitals NHS Foundation Trust

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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: incremental doses of peanut in a water-continuous matrix; incremental doses of peanut baked into a cookie biscuit; 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Food Hypersensitivity, Peanut Hypersensitivity
    Keywords
    Peanut allergy, Food allergy, Thresholds, Anaphylaxis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DBPCFC to peanut cookie, then single-dose DBPCFC x 2
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Single dose DBPCFC x 2, then DBPCFC to peanut cookie
    Arm Type
    Experimental
    Arm 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
    Intervention Type
    Other
    Intervention Name(s)
    DBPCFC to peanut cookie
    Intervention Type
    Other
    Intervention Name(s)
    Single-dose DBPCFC to peanut flour
    Intervention 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(s)
    Single-dose DBPCFC to peanut butter
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Minimum eliciting dose
    Description
    Minimum eliciting dose of peanut to trigger an objective allergic reaction according to international consensus criteria (PRACTALL))
    Time Frame
    2 hours
    Secondary Outcome Measure Information:
    Title
    Symptom pattern
    Description
    Symptoms experienced following peanut challenge (defined according to international consensus criteria (PRACTALL) )
    Time Frame
    12 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clare Mills, PhD
    Organizational Affiliation
    University of Manchester
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified data will be made public through the Integrated approaches to food allergen and allergy management (iFAAM) collaboration
    Citations:
    PubMed Identifier
    33715235
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    http://www.inflammation-repair.manchester.ac.uk/iFAAM/
    Description
    iFAAM website

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs