Can Early Introduction of Tree Nuts Prevent Tree Nut Allergy in Infants at High Risk of Tree Nut Allergy: The TreEat Study: a Randomised, Open-label Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Difference between the two treatment arms in the proportion of participants with clinical confirmed tree nut allergy at 18 months of age
研究概览
简要总结
Early and regular ingestion of the common allergens, peanut and egg has been shown to be an effective allergy prevention strategy. It is not clear whether this is also true of tree nut allergy. Current practice in many Australian allergy clinics for children with peanut allergy (high risk of tree nut allergy), is to advise families to introduce each individual tree nut into their child's diet via a cautious home introduction protocol without prior allergy testing (screening). The safety and effectiveness of an early and regular ingestion strategy for the prevention of tree nut allergy has not been formally evaluated and it is known that around a third of children with peanut allergy develop one or more other nut allergies. This trial is a 2-armed, open-label, randomized, controlled trial (RCT) to assess the safety and efficacy of a supervised hospital based multi-tree nut (almond, cashew, hazelnut and walnut) oral food challenge (OFC) + then home introduction of the remaining tree nuts versus standard care (home introduction of all 8 tree nuts) in infants with peanut allergy to reduce the risk of developing tree nut allergy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 11 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged greater than 4 months and less than 11 months of age diagnosed with IgE-mediated peanut allergy in conjunction with a positive SPT (≥3mm) or sIgE (specific immunoglobulin E) (>0.35 kU/L)
排除标准
- •Any history of severe food induced anaphylaxis. Defined as reaction requiring 2 doses of intramuscular (IM) adrenaline.
- •Pre-existing tree nut allergy (parent-reported).
- •Any tree nut already tolerated (ingestion on >3 occasions without reaction of around 1 teaspoon)
- •SPT or sIgE performed to any tree nuts
- •Not commenced or unable to eat solid food
- •Prescribed beta-blocker medication
研究组 & 干预措施
Home Introduction of Individual tree nuts
Current standard of care which is to advise families of infants diagnosed with peanut allergy to introduce tree nuts individually via a standardized, graded and cautious home introduction protocol. Day 1: smear of nut paste to the inside of lip; Day 2: 1/8 teaspoon; Day 3: 1/4 teaspoon; Day 4: 1/2 teaspoon; Day 5: 1 teaspoon. Repeat process with each individual tree nut.
干预措施: Home introduction (Other)
In hospital multi-tree nut (almond, cashew hazelnut and walnut) oral food challenge (OFC)
Infant will be booked for a 4-nut butter (Almond, Hazelnut, Walnut, and Cashew) graded and supervised OFC in the allergy clinical trials unit at the Murdoch Children's Research Institute. The nut butter contains a 1g dose of each nut protein in a total weight of 20g. Doses will be administered every 15minutes (1. Smear to inside of lip, 2.1/8 teaspoon, 3.1/4 teaspoon, 4.1/2 teaspoon, 5.1 teaspoon, 6.remainder of 20g nut butter paste) If challenge negative, infants continue home introduction of tree nuts as per written instructions provided. If challenge positive, infants will have additional SPT (for full tree nut panel) and single tree nut OFC as per protocol to determine tolerance/allergic status (and +/- home introduction recommendation) for each tree nut.
干预措施: Multi Nut oral food challenge (Other)
结局指标
主要结局
Difference between the two treatment arms in the proportion of participants with clinical confirmed tree nut allergy at 18 months of age
时间窗: 18 months of age
Tree nut allergy outcomes at 18 months will be defined as: 1. Allergic - has evidence of tree nut sensitization (SPT\>=3mm) and has had a reaction consistent with IgE (immunoglobulin E) mediated food allergy OR positive formal OFC 2. Tree nut tolerant- successfully tolerated the tree nut at home on more than 3 occasions of at least 1 teaspoon of nut per occasion OR has had a negative formal OFC. 3. Inconclusive -has an unknown outcome as ingestion has not occurred and participant declines OFC.
次要结局
- Difference between the 2 treatment arms in the number of tree nuts ingested.(18 months of age)
- Difference between the two treatment arms in the proportion and severity of solicited AEs related to tree nut ingestion.(18 months of age)
- Difference between the 2 treatment arms in the frequency of tree nuts ingested.(18 months of age)
- Difference between the two treatment arms in mean change from baseline of Quality of Life Scores using the Food Allergy Quality of Life Questionnaire (FAQLQ-PF)- Parent Form at 18 months of age.(Baseline and 18 months of age)
- Difference between the two treatment arms in the proportion and severity of reported adverse events (AE) related to tree nut ingestion.(18 months of age)
- Difference between the two treatment arms in the proportion of participants with ongoing peanut allergy at 18 months of age(18 months of age)
- Difference between the two treatment arms in the mean change from baseline in State/Trait anxiety scores using the State/Trait Anxiety Inventory(Baseline and 18 months of age)
- Difference in the number of allergy-related healthcare visits from randomization to 18 months of age between the treatment arms(18 months of age)