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| ID | Type | Description | Link |
|---|---|---|---|
| FP7-KBBE 312147 | Other Grant/Funding Number | European Commission |
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| Name | Class |
|---|---|
| University of Manchester | OTHER |
| Food Standards Agency, United Kingdom | OTHER_GOV |
| Cambridge University Hospitals NHS Foundation Trust | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBPCFC to peanut cookie, then single-dose DBPCFC x 2 | Experimental | Patients will undergo 3 sets of double-blind, placebo-controlled food challenge (DBPCFC):
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| Single dose DBPCFC x 2, then DBPCFC to peanut cookie | Experimental | Patients will undergo 3 sets of double-blind, placebo-controlled food challenge (DBPCFC):
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBPCFC to peanut cookie | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Minimum eliciting dose | Minimum eliciting dose of peanut to trigger an objective allergic reaction according to international consensus criteria (PRACTALL)) | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom pattern | Symptoms experienced following peanut challenge (defined according to international consensus criteria (PRACTALL) ) | 12 hours |
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Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Clare Mills, PhD | University of Manchester | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33715235 | Derived | 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. |
| Label | URL |
|---|---|
| iFAAM website | View source |
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De-identified data will be made public through the Integrated approaches to food allergen and allergy management (iFAAM) collaboration
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 9, 2021 | |
| Reset | Apr 2, 2021 | |
| Release | Aug 9, 2022 | |
| Reset | Jul 6, 2023 | |
| Release | Mar 26, 2024 | |
| Reset | Aug 29, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 9, 2021 | Apr 2, 2021 | |||
| Aug 9, 2022 |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D021183 | Peanut Hypersensitivity |
| D000707 | Anaphylaxis |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000074924 | Nut and Peanut Hypersensitivity |
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| 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. |
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| 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. |
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| Jul 6, 2023 |
| Mar 26, 2024 | Aug 29, 2024 |