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Test‐guided dietary management of eczema in children: a randomised, controlled feasibility trial (TEST)
Clinical & Experimental Allergy ( IF 6.3 ) Pub Date : 2021-01-15 , DOI: 10.1111/cea.13816
Matthew J Ridd 1 , Douglas Webb 1 , Kirsty Roberts 1 , Miriam Santer 2 , Joanne R Chalmers 3 , Anna Gilbertson 1 , Deb Marriage 4 , Peter S Blair 5 , Nicholas L Turner 5 , Kirsty Garfield 5, 6 , Joanna Coast 6 , Lucy E Selman 5 , Clare Clement 5 , Alison R G Shaw 1 , Ingrid Muller 2 , Lisa Waddell 7 , Elizabeth Angier 2 , Jodi Taylor 5 , Joe Kai 8 , Robert J Boyle 3, 9
Affiliation  

BACKGROUND Parents commonly ask about food allergy tests, to find a cause for their child's eczema, yet the value of routine testing is uncertain. OBJECTIVE To determine if a clinical trial comparing test-guided dietary advice versus usual care, for the management of eczema, is feasible. METHODS Children (>3 months and <5 years) with mild to severe eczema, recruited via primary care, were individually randomised (1:1) to intervention or usual care. Intervention participants underwent structured allergy history and skin prick tests (SPT) with dietary advice for cow's milk, hen's egg, wheat, peanut, cashew and codfish. All participants were followed-up for 24 weeks. A sample of doctors and parents were interviewed. Registration ISRCTN15397185. RESULTS From 1059 invitation letters sent to carers of potentially eligible children, 84 were randomised (42 per group) with mean age of 32.4 months (SD 13.9) and POEM of 8.7 (4.8). 6/42 (14%) intervention participants were advised to exclude one or more foods, most commonly egg, peanut or milk. By participant, 1/6 had an oral food challenge (negative); 3/6 were told to exclude until review in allergy clinic; and 6/6 advised a home dietary trial (exclusion and reintroduction of food over 4-6 weeks) - with 1/6 partially completing it. Participant retention (four withdrawals) and data completeness (74% to 100%) were acceptable and contamination low (two usual care participants had allergy tests). There were three minor SPT-related adverse events. During follow-up, 12 intervention and 8 usual care participants had minor, unrelated adverse events plus one unrelated hospital admission. CONCLUSIONS It is possible to recruit, randomise and retain children with eczema from primary care into a trial of food allergy screening, and to collect the outcomes of interest. Changes to recruitment and inclusion criteria are needed in a definitive trial, to ensure inclusion of younger children from more diverse backgrounds.

中文翻译:

儿童湿疹的测试指导饮食管理:一项随机、对照可行性试验 (TEST)

背景技术父母通常会询问食物过敏测试,以找出孩子湿疹的原因,但常规测试的价值并不确定。目的 确定一项比较测试指导饮食建议与常规护理的临床试验是否可行,以管理湿疹。方法 通过初级保健招募的轻度至重度湿疹儿童(>3 个月和 <5 岁)被单独随机 (1:1) 分配至干预或常规护理。干预参与者接受了结构化过敏史和皮肤点刺测试 (SPT),并提供牛奶、鸡蛋、小麦、花生、腰果和鳕鱼的饮食建议。所有参与者都接受了 24 周的随访。采访了医生和父母的样本。注册 ISRCTN15397185。结果 从 1059 封发送给可能符合条件的儿童的照顾者的邀请信中,84 人被随机分配(每组 42 人),平均年龄为 32.4 个月 (SD 13.9),POEM 为 8.7 (4.8)。6/42 (14%) 的干预参与者被建议排除一种或多种食物,最常见的是鸡蛋、花生或牛奶。根据参与者,1/6 有口服食物挑战(阴性);3/6 被告知要排除,直到在过敏诊所复查;和 6/6 建议进行家庭饮食试验(在 4-6 周内排除和重新引入食物)- 1/6 部分完成。参与者保留(四次退出)和数据完整性(74% 到 100%)是可以接受的并且污染低(两名常规护理参与者进行了过敏测试)。发生了三起与 SPT 相关的轻微不良事件。在随访期间,12 名干预参与者和 8 名常规护理参与者发生了轻微的、无关的不良事件,外加 1 名无关的住院。结论 可以招募,将患有湿疹的儿童从初级保健随机抽取并保留到食物过敏筛查试验中,并收集感兴趣的结果。最终试验需要改变招募和纳入标准,以确保纳入来自更多样化背景的年幼儿童。
更新日期:2021-01-15
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