Catassi Carlo, Fabiani Elisabetta, Iacono Giuseppe, D'Agate Cinzia, Francavilla Ruggiero, Biagi Federico, Volta Umberto, Accomando Salvatore, Picarelli Antonio, De Vitis Italo, Pianelli Giovanna, Gesuita Rosaria, Carle Flavia, Mandolesi Alessandra, Bearzi Italo, Fasano Alessio
Center For Celiac Research, University of Maryland School of Medicine, Baltimore, MD 21201, USA.
Am J Clin Nutr. 2007 Jan;85(1):160-6. doi: 10.1093/ajcn/85.1.160.
Treatment of celiac disease (CD) is based on the avoidance of gluten-containing food. However, it is not known whether trace amounts of gluten are harmful to treated patients.
The objective was to establish the safety threshold of prolonged exposure to trace amounts of gluten (ie, contaminating gluten).
This was a multicenter, double-blind, placebo-controlled, randomized trial in 49 adults with biopsy-proven CD who were being treated with a gluten-free diet (GFD) for > or =2 y. The background daily gluten intake was maintained at < 5 mg. After a baseline evaluation (t0), patients were assigned to ingest daily for 90 d a capsule containing 0, 10, or 50 mg gluten. Clinical, serologic, and histologic evaluations of the small intestine were performed at t0 and after the gluten microchallenge (t1).
At t0, the median villous height/crypt depth (Vh/Cd) in the small-intestinal mucosa was significantly lower and the intraepithelial lymphocyte (IEL) count (x 100 enterocytes) significantly higher in the CD patients (Vh/Cd: 2.20; 95% CI: 2.11, 2.89; IEL: 27; 95% CI: 23, 34) than in 20 non-CD control subjects (Vh/Cd: 2.87; 95% CI: 2.50, 3.09; IEL: 22; 95% CI: 18, 24). One patient (challenged with 10 mg gluten) developed a clinical relapse. At t(1), the percentage change in Vh/Cd was 9% (95% CI: 3%, 15%) in the placebo group (n = 13), -1% (-18%, 68%) in the 10-mg group (n = 13), and -20% (-22%, -13%) in the 50-mg group (n = 13). No significant differences in the IEL count were found between the 3 groups.
The ingestion of contaminating gluten should be kept lower than 50 mg/d in the treatment of CD.
乳糜泻（CD）的治疗基于避免食用含麸质食物。然而，尚不清楚痕量麸质对接受治疗的患者是否有害。
目的是确定长期暴露于痕量麸质（即污染性麸质）的安全阈值。
这是一项多中心、双盲、安慰剂对照的随机试验，纳入49名经活检证实患有CD且接受无麸质饮食（GFD）治疗≥2年的成年人。背景每日麸质摄入量维持在<5mg。在基线评估（t0）后，患者被分配每日服用一粒含有0、10或50mg麸质的胶囊，持续90天。在t0和麸质微量激发试验后（t1）对小肠进行临床、血清学和组织学评估。
在t0时，CD患者小肠黏膜的绒毛高度/隐窝深度（Vh/Cd）中位数显著更低，上皮内淋巴细胞（IEL）计数（每100个肠上皮细胞）显著更高（Vh/Cd：2.20；95%CI：2.11，2.89；IEL：27；95%CI：23，34），而20名非CD对照受试者（Vh/Cd：2.87；95%CI：2.50，3.09；IEL：22；95%CI：18，24）则不然。一名患者（接受10mg麸质激发）出现临床复发。在t1时，安慰剂组（n = 13）的Vh/Cd百分比变化为9%（95%CI：3%，15%），10mg组（n = 13）为 -1%（-18%，68%），50mg组（n = 13）为 -20%（-22%，-13%）。三组之间的IEL计数未发现显著差异。
在CD治疗中，污染性麸质的摄入量应保持低于50mg/d。
