Pancake Oral Immunotherapy For Egg Allergy In Inducing Tolerance (POET)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving desensitisation - tolerating a cumulative dose of 4443 mg cooked egg protein
研究概览
简要总结
Oral immunotherapy (OIT) using raw/ cooked egg has good desensitisation outcomes but is associated with frequent and sometimes severe adverse events (anaphylaxis is not uncommon). OIT using baked egg is less effective at inducing desensitisation but has a better safety profile. The compliance to daily consumption of baked egg products (muffins/ biscuits) after a negative baked egg challenge in egg allergic patients has also been reported to be poor, secondary to taste fatigue in children and need for frequent baking. A study using baked egg OIT had 38% withdrawal due to difficulties in ingesting the baked egg product daily. Pancakes, traditionally described as a flat cake prepared from a starch-based batter containing egg and milk and cooked on a hot surface for 5-7 minutes, is likely to be less allergenic than cooked egg because of the wheat matrix but more allergenic than baked egg. To date, there are no published studies investigating the use of pancakes in egg OIT. The investigators hypothesize that pancakes are more effective than baked eggs in inducing desensitisation and sustained unresponsiveness while reducing the risk of adverse events associated with egg OIT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allergic to 4.443g egg protein or less, at baseline egg open food challenge OR Convincing clinical reaction to egg within past 6 months (or failed a clinical egg food challenge in last 6 months) AND evidence of current sensitization (positive SPT or egg-specific IgE performed within the last 3 months)
排除标准
- •Subjects meeting any of the exclusion criteria at baseline will be excluded from participation.
- •Required previous admission to an intensive care unit for management of an allergic reaction.
- •Children with a past history of egg allergy currently consuming egg-containing products other than extensively-heated egg in baked foods (e.g. biscuits, cakes).
- •Developed severe anaphylaxis to egg or egg-containing products requiring more than 2 adrenaline auto-injectors or intravenous adrenaline infusion.
- •Poorly controlled asthma within the previous 3 months (as defined by clinician judgement with reference to the ICON guidelines).
- •Moderate-severe eczema despite appropriate use of emollients (eczema is not otherwise an exclusion criteria).
- •Clinically significant chronic illness (other than asthma, rhinitis or eczema).
- •History of symptoms of eosinophilic oesophagitis, irrespective of cause.
- •Undergoing specific immunotherapy to another allergen and within the first year of treatment.
- •Receiving anti-IgE therapy, oral immunosuppressants, beta-blocker or ACE inhibitor.
- •Pregnancy.
- •Unwilling or unable to fulfil study requirements.
结局指标
主要结局
Proportion of participants achieving desensitisation - tolerating a cumulative dose of 4443 mg cooked egg protein
时间窗: 12-18 months
次要结局
- Proportion of participants achieving sustained unresponsiveness - tolerating a cumulative dose of 4443 mg cooked egg protein after 6-8 weeks of egg abstinence(12-18 months)
- Number of treatment-related adverse reactions as assessed by CoFAR Grading(12-18 months)
- Change in skin prick test wheal size to egg white(12-18 months)
- Change in serum IgE levels to egg white, ovomucoid, ovalbumin(12-18 months)
- Change in Food-Allergy Quality of Life Questionnaire (FAQL-Q) scores(12-18 months)
研究者
Chong Kok Wee
Principal Investigator
KK Women's and Children's Hospital