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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02665793
Acronym
TRACEextension
Enrollment
17
Registered
2016-01-28
Start date
2016-08-31
Completion date
2017-05-19
Last updated
2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Hypersensitivity, Peanut Hypersensitivity

Keywords

Peanut allergy, Food allergy, Thresholds, Anaphylaxis

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.

Interventions

OTHERDBPCFC to peanut cookie
OTHERSingle-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.

OTHERSingle-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.

Sponsors

University of Manchester
CollaboratorOTHER
Food Standards Agency, United Kingdom
CollaboratorOTHER_GOV
Cambridge University Hospitals NHS Foundation Trust
CollaboratorOTHER
Imperial College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Minimum eliciting dose2 hoursMinimum eliciting dose of peanut to trigger an objective allergic reaction according to international consensus criteria (PRACTALL))

Secondary

MeasureTime frameDescription
Symptom pattern12 hoursSymptoms experienced following peanut challenge (defined according to international consensus criteria (PRACTALL) )

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026