TRANS-FOODS: Preventing Peanut Allergy Through Improved Understanding of the Transcutaneous Sensitisation Route, Novel Food Processing and Skin Care Adaptations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Detection of peanut protein components (μg of the proteins per cm² of skin) in retrieved interstitial fluid.
研究概览
简要总结
This project aims to study the immune responses to peanut allergen in those with a skin barrier defect with and without skin massage, specifically it aims to:
- Establish if peanut allergen components can pass into human skin through regular massage using the peanut protein-containing extract.
- Clarify whether this effect is amplified in those with an impaired skin barrier (AD and dry skin vs healthy controls).
- Assess whether peanut protein components can be detected in interstitial skin fluid (ISF) using a suction device.
- Test whether peanut protein components present in ISF are able to induce activation of basophils in blood of peanut allergic donors.
- Assess whether the transcutaneous uptake of peanut protein can be reduced by the prior use of a barrier enhancing cream.
详细描述
The study aims to understand how peanut processing methods and peanut co-administration with oils, as is standard during the industrial processing of peanuts, influences the development of peanut allergy through the skin.
Cutaneous exposure of allergens is a crucial, but hitherto under explored route of food sensitisation, that if understood could lead to the development of translatable strategies to prevent food allergy. Food processors require a greater understanding of how allergen exposure cause allergy so that they can adapt their processing methods to counteract these exposure processes. Furthermore, this proposed research aligns with on-going efforts across Europe to address the increasing problems associated with food allergy but it is unique in that it focuses on cutaneous allergen exposure, which is a field in desperate need of more systematic study.
The assembled team of investigators (from the UK, Germany and France) joined by a peanut industry partner (Levantine) and patient and consumer representatives will aim to address the following hypotheses:
Understanding the mechanisms by which:
- Peanut proteins pass into the skin via the appendages to trigger an immune response.
- Skin stretching that occurs during massage opens up the skin appendages allowing more peanut protein into the skin and leads to dendritic cell activation and induction of T helper 2 cell response.
- Co-administration of peanut proteins and an oil to the skin increases allergenicity.
- Skin barrier impairment and inflammation (AD) increases allergenicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult healthy volunteers (50% of the cohort), and adults with dry skin and AD (fulfilling the refined Hanifin and Rajka criteria, 50% of the cohort).
- •Willingness to apply the study intervention and to not use any other topical preparations over theforearms during the study period.
排除标准
- •History of peanut allergy.
- •Positive skin prick test to peanut (>0 mm).
- •No regular consumption of peanut products.
- •Widespread AD, in particular if this involves the test sites of the forearms.
结局指标
主要结局
Detection of peanut protein components (μg of the proteins per cm² of skin) in retrieved interstitial fluid.
时间窗: 8 weeks
Detection of peanut protein components (μg of the proteins per cm² of skin) in retrieved interstitial fluid.
Activation of blood basophil from peanut allergic donors (measured as %CD63-positive basophils) by peanut proteins present in interstitial fluid.
时间窗: 8 weeks
Activation of blood basophil from peanut allergic donors (measured as %CD63-positive basophils) by peanut proteins present in interstitial fluid.
次要结局
- Raised transepidermal water loss.(8 weeks)
- Detection of inflammatory cytokine markers (IL-4, IL-13, IL-33 and TSLP) in interstitial fluid.(8 weeks)