Evidence for the Presence of Non-Celiac Gluten Sensitivity in Patients with Functional Gastrointestinal Symptoms: Results from a Multicenter Randomized Double-Blind Placebo-Controlled Gluten Challenge.
Evidence for the Presence of Non-Celiac Gluten Sensitivity in Patients with Functional Gastrointestinal Symptoms: Results from a Multicenter Randomized Double-Blind Placebo-Controlled Gluten Challenge.
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DOI：
10.3390/nu8020084
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发表时间：
2016-02-08
期刊：
影响因子：
5.9
通讯作者：
Buscarini E
中科院分区：
文献类型：
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作者：
Elli L;Tomba C;Branchi F;Roncoroni L;Lombardo V;Bardella MT;Ferretti F;Conte D;Valiante F;Fini L;Forti E;Cannizzaro R;Maiero S;Londoni C;Lauri A;Fornaciari G;Lenoci N;Spagnuolo R;Basilisco G;Somalvico F;Borgatta B;Leandro G;Segato S;Barisani D;Morreale G;Buscarini E
非腹腔麸质敏感性（NCGS）的特征是在食用含麸质的食物后出现症状。我们的目的是在有功能性胃肠道症状的受试者中挑出NCGS受试者。患者入组一项多中心、双盲、安慰剂对照、交叉试验。通过10 cm VAS和SF 36评估症状和生活质量。评价铁参数、转氨酶和C反应蛋白（CRP）。在为期三周的无麸质饮食（GFD）后，有反应的患者被随机分配到麸质摄入量（5.6 g/天）或安慰剂组7天，然后交叉。主要终点是与安慰剂相比，谷蛋白摄入期间症状恶化（VAS增加≥3 cm）。入组了140例患者，134例（17例男性，平均年龄39.1 ± 11.7岁，BMI 22.4 ± 3.8）完成了第一阶段。共有101例受试者（10例男性，平均年龄39.3 ± 11.0岁，BMI 22.3 ± 4.0）报告症状改善（VAS评分2.3 ± 1.2 vs. GFD前后6.5 ± 2.2，p = 0.001）。98例患者接受了谷蛋白激发，28例（均为女性，平均年龄38.9 ± 12.7岁，BMI 22.0 ± 2.9）报告了症状复发和生活质量恶化。未发现与攻毒阳性具有统计学相关性的参数。然而，14名患者对安慰剂摄入有反应。考虑到这一发现，大约14%的对麸质戒断有反应的患者在麸质挑战期间表现出症状复发。这个群体被怀疑有NCGS。
Non-celiac gluten sensitivity (NCGS) is characterized by the onset of symptoms after eating gluten-containing food. We aimed to single out NCGS subjects among subjects with functional gastrointestinal symptoms. Patients were enrolled in a multicenter double-blind placebo-controlled trial with crossover. Symptoms and quality of life were evaluated by means of 10-cm VAS and SF36. Iron parameters, transaminases and C reactive protein (CRP) were evaluated. After a three-week-long gluten-free diet (GFD), responsive patients were randomly assigned to gluten intake (5.6 g/day) or placebo for seven days, followed by crossover. The primary endpoint was the worsening of symptoms (VAS increase ≥3 cm) during gluten ingestion compared to placebo. One hundred and forty patients were enrolled and 134 (17 males, mean age 39.1 ± 11.7 years, BMI 22.4 ± 3.8) completed the first period. A total of 101 subjects (10 males, mean age 39.3 ± 11.0 years, BMI 22.3 ± 4.0) reported a symptomatic improvement (VAS score 2.3 ± 1.2 vs. 6.5 ± 2.2 before and after GFD, p = 0.001). 98 patients underwent the gluten challenge and 28 (all females, mean age 38.9 ± 12.7 years, BMI 22.0 ± 2.9) reported a symptomatic relapse and deterioration of quality of life. No parameters were found to be statistically associated with positivity to the challenge. However, 14 patients responded to the placebo ingestion. Taking into account this finding, about 14% of patients responding to gluten withdrawal showed a symptomatic relapse during the gluten challenge. This group is suspected to have NCGS.