Department of Pediatrics, Marche Polytechnic University, Ancona, Italy.
Department of Pediatrics, Marche Polytechnic University, Ancona, Italy.
J Pediatr. 2018 Mar;194:116-122.e2. doi: 10.1016/j.jpeds.2017.10.062.
To evaluate the long-term validity and safety of pure oats in the treatment of children with celiac disease.
This noninferiority clinical trial used a double-blind, placebo-controlled, crossover design extended over 15 months. Three hundred six children with a biopsy-proven diagnosis of celiac disease on a gluten-free diet for ≥2 years were randomly assigned to eat specifically prepared gluten-free food containing an age-dependent amount (15-40 g) of either placebo or purified nonreactive varieties of oats for 2 consecutive 6-month periods separated by washout standard gluten-free diet for 3 months. Clinical (body mass index, Gastrointestinal Symptoms Rating Scale score), serologic (IgA antitransglutaminase antibodies, and IgA anti-avenin antibodies), and intestinal permeability data were measured at baseline, and after 6, 9, and 15 months. Direct treatment effect was evaluated by a nonparametric approach using medians (95% CI) as summary statistic.
After the exclusion of 129 patients who dropped out, the cohort included 177 children (79 in the oats-placebo and 98 in the placebo-oats group; median, 0.004; 95% CI, -0.0002 to 0.0089). Direct treatment effect was not statistically significant for clinical, serologic, and intestinal permeability variables (body mass index: median, -0.5; 95% CI, -0.12 to 0.00; Gastrointestinal Symptoms Rating Scale score: median, 0; 95% CI, -2.5 to 0.00; IgA antitransglutaminase antibodies: median, -0.02; 95% CI, -0.25 to 0.23; IgA anti-avenin antibodies: median, -0.0002; 95% CI, -0.0007 to 0.0003; intestinal permeability test: median, 0.004; 95% CI, -0.0002 to 0.0089).
Pure nonreactive oat products are a safe dietary choice in the treatment of children with celiac disease.
ClinicalTrials.gov: NCT00808301.
评估纯燕麦在治疗儿童乳糜泻中的长期有效性和安全性。
这是一项非劣效性临床试验，采用双盲、安慰剂对照、交叉设计，时间跨度为 15 个月。306 名经活检证实的乳糜泻患儿在无麸质饮食中接受治疗，时间均≥2 年，他们被随机分为两组，分别食用含有年龄依赖性剂量（15-40g）的安慰剂或经过特殊制备的无反应性燕麦的无麸质食物，连续食用 2 个 6 个月的疗程，其间用标准无麸质饮食洗脱 3 个月。在基线时以及 6、9 和 15 个月时测量临床（体重指数、胃肠道症状评分量表评分）、血清学（IgA 抗转谷氨酰胺酶抗体和 IgA 抗燕麦蛋白抗体）和肠通透性数据。直接治疗效果通过非参数方法进行评估，采用中位数（95%CI）作为汇总统计量。
在排除 129 名退出的患者后，该队列纳入了 177 名患儿（燕麦-安慰剂组 79 名，安慰剂-燕麦组 98 名；中位数为 0.004；95%CI，-0.0002 至 0.0089）。在临床、血清学和肠通透性变量方面，直接治疗效果无统计学意义（体重指数：中位数，-0.5；95%CI，-0.12 至 0.00；胃肠道症状评分量表评分：中位数，0；95%CI，-2.5 至 0.00；IgA 抗转谷氨酰胺酶抗体：中位数，-0.02；95%CI，-0.25 至 0.23；IgA 抗燕麦蛋白抗体：中位数，-0.0002；95%CI，-0.0007 至 0.0003；肠通透性试验：中位数，0.004；95%CI，-0.0002 至 0.0089）。
纯无反应性燕麦产品是治疗乳糜泻儿童的安全饮食选择。
ClinicalTrials.gov：NCT00808301。
