Immunology Department, Perth Children's Hospital, Nedlands, Western Australia, Australia
The University of Western Australia, Perth, Western Australia, Australia.
BMJ Paediatr Open. 2023 Nov;7(1). doi: 10.1136/bmjpo-2023-002294.
Food allergy is a major public health challenge in Australia. Despite widespread uptake of infant feeding and allergy prevention guidelines the incidence of peanut allergy in infants has not fallen, and prevalence of peanut allergy in school-aged children continues to rise. Therefore, effective and accessible treatments for peanut allergy are required. There is high-quality evidence for efficacy of oral immunotherapy in children aged 4-17 years old; however, few randomised trials have investigated peanut oral immunotherapy (OIT) in young children. Furthermore, the use of food products for OIT with doses prepared and administered by parents without requiring pharmacy compounding has the potential to reduce costs associated with the OIT product.
Early Peanut Immunotherapy in Children is an open-label randomised controlled trial of peanut OIT compared with standard care (avoidance) to induce desensitisation in children aged 1-4 years old with peanut allergy. n=50 participants will be randomised 1:1 to intervention (daily peanut OIT for 12 months) or control (peanut avoidance). The primary outcome is the proportion of children in each group with a peanut eliciting dose >600 mg peanut protein as assessed by open peanut challenge after 12 months, analysed by intention to treat. Secondary outcomes include safety as assessed by frequency and severity of treatment-related adverse events, quality of life measured using age-appropriate food allergy-specific questionnaires and immunological changes during OIT.
The trial is approved by the Child and Adolescent Health Service Human Research Ethics Committee and prospectively registered with the Australia and New Zealand Clinical Trials Registry.
Trial outcomes will be published in a peer-review journal and presented and local and national scientific meetings.
ACTRN12621001001886.
食物过敏是澳大利亚面临的一个主要公共卫生挑战。尽管广泛采用了婴儿喂养和过敏预防指南，但婴儿花生过敏的发病率并未下降，学龄儿童花生过敏的患病率仍在继续上升。因此，需要有效的、易于获得的花生过敏治疗方法。高质量证据表明，4-17 岁儿童口服免疫疗法有效；然而，很少有随机试验研究过幼儿花生口服免疫疗法（OIT）。此外，使用无需药房配制即可由父母制备和管理剂量的食品产品进行 OIT，有可能降低与 OIT 产品相关的成本。
儿童早期花生免疫治疗是一项开放标签随机对照试验，比较了花生 OIT 与标准护理（回避）在 1-4 岁花生过敏儿童中诱导脱敏的效果。n=50 名参与者将按照 1:1 的比例随机分为干预组（每日花生 OIT 治疗 12 个月）或对照组（回避花生）。主要结局是在 12 个月后通过开放花生挑战评估的每组中具有 >600mg 花生蛋白的花生激发剂量的儿童比例，通过意向治疗进行分析。次要结局包括安全性，通过治疗相关不良事件的频率和严重程度评估；使用适合年龄的食物过敏特异性问卷评估生活质量；以及在 OIT 期间的免疫变化。
该试验已获得儿童和青少年健康服务机构人类研究伦理委员会的批准，并在澳大利亚和新西兰临床试验注册处进行了前瞻性注册。
试验结果将在同行评审期刊上发表，并在当地和全国科学会议上进行报告和展示。
ACTRN12621001001886。
