权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Transforming oral food challenges for gold-standard food allergy diagnosis and management in young children

改变幼儿食物过敏金标准诊断和管理的口服食物挑战

基本信息

批准号：
10018338
负责人：
金额：
$ 83.48万
依托单位：
REACTA BIOTECH LIMITED
依托单位国家：
英国
项目类别：
Collaborative R&D
财政年份：
2022
资助国家：
英国
起止时间：
2022 至无数据
项目状态：
已结题

来源：
https://gtr.ukri.org/projects?ref=10018338
关键词：
Transforming oral food challenges gold

项目摘要

Food allergy (FA) prevalence and hospitalisations are rising, especially in young children. Sufferers and their families face possible death from anaphylaxis, social exclusion, reduced Quality of Life, and high out-of-pocket costs. New treatments promise to revolutionise FA, stimulating strong demand for partner diagnostics. Today's gold-standard FA diagnostic is the double-blind, placebo-controlled food challenge (DBPCFC). Here, patients consume the suspect food, in incrementally increasing amounts, until a mild allergic reaction is observed versus an indistinguishable low/zero dose control challenge. However, current tests are unblinded, inaccurate, poorly scalable, and unsafe. This leaves the UK poorly equipped to face the large numbers of tests that will be required for vulnerable paediatric patients in the coming years.Reacta Biotech have developed a patented DBPCFC formulation for peanut-allergic adult patients produced under controlled conditions. The project builds on this technology by developing and validating novel DBPCFC formulations for young children that will be safer, more accurate, and more widely applicable than current clinical practice. The formulations will be applied in human trials following the project to fully evaluate their clinical utility. Scaled production and marketing of the resultant diagnostic products has the potential to directly save over £1.2Bn for patients and the healthcare system.

食物过敏 (FA) 患病率和住院率不断上升，尤其是幼儿。患者及其家人可能因过敏反应、社会排斥、生活质量下降和高昂的自付费用而死亡。新疗法有望彻底改变 FA，刺激对合作伙伴诊断的强劲需求。当今 FA 诊断的黄金标准是双盲、安慰剂对照食物挑战 (DBPCFC)。在这里，患者逐渐增加食用可疑食物的量，直到观察到轻微的过敏反应与难以区分的低/零剂量控制挑战。然而，当前的测试是非盲的、不准确的、可扩展性差且不安全的。这使得英国在未来几年中无力应对脆弱儿科患者所需的大量测试。Reacta Biotech 已开发出一种专利 DBPCFC 配方，用于在受控条件下生产的花生过敏成人患者。该项目以该技术为基础，为幼儿开发和验证新型 DBPCFC 配方，该配方将比当前的临床实践更安全、更准确、更广泛适用。项目完成后，该制剂将应用于人体试验，以全面评估其临床效用。由此产生的诊断产品的规模化生产和营销有可能直接为患者和医疗保健系统节省超过 12 亿英镑。