Food HypersensitivityTRACEextensionNCT02665793
Mechanisms Underlying Peanut Allergic Reactions in TRACE Peanut Study Participants: Extension Study
A study testing DBPCFC to peanut cookie, Single-dose DBPCFC to peanut flour and Single-dose DBPCFC to peanut butter in people with Food Hypersensitivity and Peanut Hypersensitivity, run by Imperial College London.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Food Hypersensitivity, Peanut Hypersensitivity
- What is being tested?
- DBPCFC to peanut cookie, Single-dose DBPCFC to peanut flour and Single-dose DBPCFC to peanut butter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to 19 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- unable to comply with study procedures
About this study
Official title: Mechanisms Underlying the Change in Threshold or Severity of Peanut-allergic Reactions in TRACE Peanut Study Participants - Extension Study
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.
Read more
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.
- Conditions
- Food Hypersensitivity, Peanut Hypersensitivity
- Being tested
- DBPCFC to peanut cookie, Single-dose DBPCFC to peanut flour, Single-dose DBPCFC to peanut butter
- Keywords
- Peanut allergy, Food allergy, Thresholds, Anaphylaxis
- Medical subject headings
- Food Hypersensitivity, Peanut Hypersensitivity, Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBPCFC to peanut cookieOther
Single-dose DBPCFC to peanut flourOther
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.
Single-dose DBPCFC to peanut butterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: DBPCFC to peanut cookie; Other: Single-dose DBPCFC to peanut flour; Other: Single-dose DBPCFC to peanut butter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum eliciting dose
Minimum eliciting dose of peanut to trigger an objective allergic reaction according to international consensus criteria (PRACTALL))
Measured: 2 hours
Secondary outcomes (1)
Symptom pattern
Symptoms experienced following peanut challenge (defined according to international consensus criteria (PRACTALL) )
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startAug 2016
- Primary completion19 May 2017
- Study completion19 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food HypersensitivityStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, Food Standards Agency, United Kingdom, Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Paul Turner, Imperial College London
- Investigators
- Clare Mills, PhD, Study chair, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665793
- Sponsor's protocol ID
- 15SM2445 vs4.1 27.12.2015
- Other IDs
- FP7-KBBE 312147
- Acronym
- TRACEextension
- Status last verified
- Oct 2019
- First submitted
- 25 Jan 2016
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified data will be made public through the Integrated approaches to food allergen and allergy management (iFAAM) collaboration
Publications
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.
PubMed 33715235
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Underlying the Change in Threshold or Severity of Peanut-allergic Reactions in TRACE Peanut Study Participants - Extension Study
- ClinicalTrials.gov ID
- NCT02665793
- Acronym / sponsor ID
- TRACEextension / 15SM2445 vs4.1 27.12.2015
- Conditions
- Food Hypersensitivity, Peanut Hypersensitivity
- Keywords
- Peanut allergy, Food allergy, Thresholds, Anaphylaxis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- University of Manchester, Food Standards Agency, United Kingdom, Cambridge University Hospitals NHS Foundation Trust
- Study start
- Aug 2016 (actual)
- Primary completion
- 19 May 2017 (actual)
- Study completion
- 19 May 2017 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBPCFC to peanut cookie, then single-dose DBPCFC x 2 | Experimental | Other: DBPCFC to peanut cookie, Other: Single-dose DBPCFC to peanut flour, Other: Single-dose DBPCFC to peanut butterPatients 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 |
| Single dose DBPCFC x 2, then DBPCFC to peanut cookie | Experimental | Other: DBPCFC to peanut cookie, Other: Single-dose DBPCFC to peanut flour, Other: Single-dose DBPCFC to peanut butterPatients 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- unable to comply with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 flourSingle-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. | 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 butterSingle-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. | Other | DBPCFC to peanut cookie, then single-dose DBPCFC x 2, Single dose DBPCFC x 2, then DBPCFC to peanut cookie |
Primary outcome
Minimum eliciting dose
Time frame: 2 hours
Minimum eliciting dose of peanut to trigger an objective allergic reaction according to international consensus criteria (PRACTALL))
1 secondary outcome
Symptom pattern
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Derived from this study: PubMed 33715235Turner 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.
- iFAAM websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data will be made public through the Integrated approaches to food allergen and allergy management (iFAAM) collaboration
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clare Mills, PhD study chair
University of Manchester
Questions about this trial
What is this clinical trial studying?
A study testing DBPCFC to peanut cookie, Single-dose DBPCFC to peanut flour and Single-dose DBPCFC to peanut butter in people with Food Hypersensitivity and Peanut Hypersensitivity, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum eliciting dose (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02665793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.