Diagnosis of celiac disease on a gluten-free diet: a multicenter prospective quasi-experimental clinical study

Sara Gomez-Aguililla, Sergio Farrais, Natalia Lopez-Palacios, Beatriz Arau, Carla Senosiain, Maria Corzo, Nora Fernandez-Jimenez, Angela Ruiz-Carnicer, Fernando Fernandez-Bañares, Barbara P Gonzalez-Garcia, Eva Tristan, Ana Montero-Calle, Maria Garranzo-Asensio, Isabel Casado, Mar Pujals, Juana Maria Hernandez, Jorge Infante-Menendez, Garbiñe Roy, Carolina Sousa, Concepcion Nuñez
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Abstract

Background Diagnosing celiac disease (CD) in individuals adhering to a gluten-free diet (GFD) presents significant challenges. Current guidelines recommend a gluten challenge (GC) lasting at least 6-8 weeks, which has several limitations. Objectives This study compares four approaches previously proposed for diagnosing CD on a GFD: IL-2 serum levels, gut-homing CD8+ T cells, %TCRγδ+ intraepithelial lymphocytes (IELs), and UBE2L3 gene expression. Additionally, we evaluated the CD8+ T-cell based method with a 3-day GC against the standard GC protocol. Methods We conducted a multicenter prospective quasi-experimental clinical study. Two subsets of individuals were considered: 1) 20 patients with CD and 15 non-CD controls previously diagnosed, to evaluate the first aim; 2) 45 individuals with uncertain diagnosis who were on a GFD and required GC following current clinical guidelines, to assess the second aim. All participants underwent a 3-day GC (10 g gluten/day). Results Among CD patients and non-CD controls, the sensitivity and specificity of IL-2, gut-homing CD8+ T cells, and UBE2L3 were 82.4% and 83.3%, 88.2% and 100%, and 52.9% and 100%, respectively. The percentage of TCRγδ+ IELs showed 88.2% sensitivity. In the uncertain diagnosis group, a CD8+ T-cell positive response was observed in 8 of the 45 subjects. Conclusion The percentage of TCRγδ+ IELs and the gut-homing CD8+ T-cell assay are promising diagnostic methods for CD on a GFD. Notably, the CD8+ T-cell assay provides a consistent and reliable alternative to the extended GC, eliminating the need for the invasive procedures to obtain duodenal samples and the prolonged gluten ingestion.
通过无麸质饮食诊断乳糜泻:一项多中心前瞻性准实验临床研究
背景对坚持无麸质饮食(GFD)的人诊断乳糜泻(CD)是一项重大挑战。本研究比较了之前提出的四种诊断无麸质饮食 CD 的方法:IL-2 血清水平、肠道归巢 CD8+ T 细胞、%TCRγδ+ 上皮内淋巴细胞(IELs)和 UBE2L3 基因表达。此外,我们还对基于 CD8+ T 细胞的 3 天 GC 方法与标准 GC 方案进行了评估。方法我们进行了一项多中心前瞻性准实验临床研究。研究考虑了两组个体:1)20 名先前确诊的 CD 患者和 15 名非 CD 对照组,以评估第一个目的;2)45 名诊断不明确的个体,他们正在服用 GFD,并需要按照现行临床指南进行 GC,以评估第二个目的。结果在CD患者和非CD对照组中,IL-2、肠道归巢CD8+ T细胞和UBE2L3的敏感性和特异性分别为82.4%和83.3%、88.2%和100%、52.9%和100%。TCRγδ+ IELs 的敏感性为 88.2%。在不确定诊断组中,45 名受试者中有 8 人出现了 CD8+ T 细胞阳性反应。结论TCRγδ+ IELs的百分比和肠道归巢CD8+ T细胞检测是GFD上CD的有前途的诊断方法。值得注意的是,CD8+ T 细胞检测为扩展 GC 提供了一个稳定可靠的替代方法,无需通过侵入性程序获取十二指肠样本,也无需长时间摄入麸质。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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