Mechanisms Underlying the Change in Threshold or Severity of Peanut-allergic Reactions in TRACE Peanut Study Participants - Extension Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Minimum eliciting dose
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
DBPCFC to peanut cookie, then single-dose DBPCFC x 2
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
干预措施: DBPCFC to peanut cookie (Other)
DBPCFC to peanut cookie, then single-dose DBPCFC x 2
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
干预措施: Single-dose DBPCFC to peanut flour (Other)
DBPCFC to peanut cookie, then single-dose DBPCFC x 2
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
干预措施: Single-dose DBPCFC to peanut butter (Other)
Single dose DBPCFC x 2, then DBPCFC to peanut cookie
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
干预措施: DBPCFC to peanut cookie (Other)
Single dose DBPCFC x 2, then DBPCFC to peanut cookie
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
干预措施: Single-dose DBPCFC to peanut flour (Other)
Single dose DBPCFC x 2, then DBPCFC to peanut cookie
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
干预措施: Single-dose DBPCFC to peanut butter (Other)
结局指标
主要结局
Minimum eliciting dose
时间窗: 2 hours
Minimum eliciting dose of peanut to trigger an objective allergic reaction according to international consensus criteria (PRACTALL))
次要结局
- Symptom pattern(12 hours)
研究者
Paul Turner
Clinician Scientist and Hon Consultant in Paediatric Allergy & Immunology
Imperial College London