Transepidermal Water Loss as a Predictor for Severe Allergic Reactions in Oral Food Challenges
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Anaphylaxis Occurrence Rates in Each Group
研究概览
简要总结
This research study is testing a new way to look for the early stages of anaphylaxis. Eligible participants will have a small monitor (transepidermal water loss) placed on the forearm during a food challenge (for peanut allergies). This monitor continuously records the amount of water lost through the skin.
In a previous study the team learned what values are associated with an anaphylactic reaction. These values are called "stopping rules." This study is looking at whether it can use these new stopping rules to end the oral food challenge before a person may show any symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participants and families, the food allergy nurse administering the oral food challenge (OFC), and the allergist physician assessing and treating the patient will be blinded to the study arm status.
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a known history of food anaphylaxis to peanut confirmed by an allergist
- •Have had skin and blood food allergy testing to peanut within the past 12 months. Meet the 80% likelihood positive predictive value threshold for peanut allergy based on at least 1 of either the skin or blood immunoglobulin E (IgE) tests per current literature corrected for age.
- •Meet all clinical oral food challenge (OFC) requirements. This includes no asthma or atopic dermatitis exacerbations, no recent viral infections, no recent antibiotics, and no food allergy reactions in the past month.
排除标准
- •Any known cardiovascular disease, cancer, pulmonary disease except well-controlled asthma, or other condition that would preclude an OFC otherwise.
- •Any medication use that would interfere with an OFC result. Medications in this category include antihistamines (first or second generation) within 1 week, omalizumab within 3 months, and others listed in the protocol appendix.
- •Any skin condition aside from well-controlled eczema that might impact TEWL measurement, including such conditions as autoimmune skin conditions (such as psoriasis), congenital ichthyoses, hyper-IgE syndromes.
结局指标
主要结局
Anaphylaxis Occurrence Rates in Each Group
时间窗: Approximately 4-6 hours (Day 1 during the food challenge)
Any Brighton Level 1, 2, or 3 anaphylaxis. The Brighton Level is a system for classifying the severity and diagnostic certainty of anaphylaxis cases, particularly in the context of adverse events following immunization. Results reflect the number of participants who experienced any of the Brighton Level 1, 2, or 3 anaphylaxis events.
次要结局
- Reaction Rates in Each Group(Approximately 4-6 hours (Day 1 during the food challenge))
- Anaphylaxis Severity in Each Group(Approximately 4-6 hours (Day 1 during the food challenge))
- Anaphylaxis Likelihood in Each Group Based on the Brighton Score(Approximately 4-6 hours (Day 1 during the food challenge))
研究者
Charles (Chase) Schuler
Assistant Professor of Allergy and Clinical Immunology and Assistant Professor of Mary H Weiser Food Allergy
University of Michigan