Evaluation of Novel Technologies to Improve Clinical Management of Celiac Disease

项目总结 拟议的项目需要进行严格的试验，以测试新型面筋检测的有效性 技术作为远程医疗的辅助手段来管理成人的乳糜泻。乳糜泻的发病率约为1% 美国(美国)自20世纪50年代以来，美国的人口和血清阳性率增加了5倍，S 随着诊断率的持续上升。发病率可能很严重，包括贫血、不孕不育、骨质疏松症、 和恶性肿瘤，这可能会增加全因死亡率。唯一被证实的治疗方法是严格的无麸质饮食， 对这种疾病的管理可能极具挑战性，并与生活质量下降有关，包括 焦虑、抑郁和疲劳。尽管建议定期去看营养师，但许多人患有乳糜泻 疾病根本看不到一次，或者在确诊后只有一次治疗。新冠肺炎大流行 促进了远程医疗在胃肠病学中的迅速采用，并可以促进 患者和营养师，消除了在乳糜泻中心安排面对面的会议的需要，这 可能在很远的地方。利用食品中面筋检测的新技术进行自我监测(例如，便携式面筋 传感器)和尿液(例如面筋免疫原肽试剂盒)可以促进个人对面筋的更多了解 曝光，商业上对公众开放，并已被证明是有效和可靠的。内科医生 营养学家被问到是否应该使用这些技术，我们的初步研究已经 证明了可接受性和可行性，但它们对临床结果的影响，如粘膜恢复和 症状尚未确定。拟议的U34项目将为多中心(纽约， 马萨诸塞州，伊利诺伊州，田纳西州)随机对照试验(M-RCT)评估有效性和 记录面筋检测技术作为远程医疗的辅助手段在行为和临床方面的成本 新诊断的乳糜泻患者的结局。参与者将被随机分配到 1)护理标准(即一次性面对面营养师会议加上持续的远程医疗营养师跟踪； 2)标准护理+面筋检测技术。这将是第一次大规模的临床试验来测试 利用面筋检测技术进行自我监测在乳糜泻治疗中的作用。初级阶段 随机化后12个月的结果是粘膜恢复。次要结果包括 胃肠道症状、饮食依从性、生活质量(包括焦虑和抑郁)、饮食行为、 组织学上皮内淋巴细胞计数，以及腹腔疾病血清学，所有这些都在基线时进行评估，并再次进行 在随机化后12个月。拟议的项目将为M-RCT制定U01提案，该提案将 包括临床方案、程序手册以及记录研究设计详细时间表和预算 以及措施、培训和协议执行、数据处理和结果的传播。这个 这项U34工作的意义是确保M-RCT在方法上是合理的，并准备好实施。如果 成功后，拟议的未来U01干预将改善粘膜恢复和生活质量，促进 目前的乳糜泻管理实践向长期监测转变，这是一个重要的 逐步减少乳糜泻对身体和心理造成的严重后果。

PROJECT SUMMARY The proposed project addresses the need for a rigorous trial to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in adults. Celiac disease affects about 1% of the United States (U.S.) population and seroprevalence has increased up to 5-fold in the U.S. since the 1950’s with diagnosis rates continuing to rise. Morbidity can be severe and includes anemia, infertility, osteoporosis, and malignancies, which can increase all-cause mortality. The only proven therapy is a strict gluten-free diet, the management of which can be extremely challenging and has been linked to diminished quality of life, including anxiety, depression, and fatigue. Despite the recommendation to see a dietitian regularly, many with celiac disease do not see one at all or have only a single session immediately post-diagnosis. The COVID-19 pandemic has catalyzed the rapid adoption of telemedicine in gastroenterology and can facilitate communication between patient and dietitian by eliminating the need to arrange face-to-face meetings at celiac disease centers, which may be at great distance. Self-monitoring with new technologies for gluten detection in food (e.g., portable gluten sensors) and urine (e.g., gluten immunogenic peptide kits) can facilitate greater individual awareness of gluten exposures, are commercially available to the public, and have been shown to be valid and reliable. Physicians and dietitians are being asked if these technologies should be used, and our preliminary studies have demonstrated acceptability and feasibility, but their impact on clinical outcomes such as mucosal recovery and symptoms has not been established. The proposed U34 project will prepare for a multi-center (New York, Massachusetts, Illinois, Tennessee) randomized controlled trial (M-RCT) to assess the effectiveness and document costs of gluten detection technologies as an adjunct to telemedicine on behavioral and clinical outcomes among newly diagnosed patients with celiac disease. Participants will be randomized to receive either 1) standard of care (i.e. a one-time in-person dietitian session plus continuous telemedicine dietitian follow-up; or 2) standard of care + gluten detection technologies. This would be the first large-scale clinical trial to test the effect of self-monitoring using gluten detection technology in the management of celiac disease. The primary outcome will be mucosal recovery 12-months post-randomization. Secondary outcomes include change in gastrointestinal symptoms, diet adherence, quality of life (including anxiety and depression), eating behaviors, intraepithelial lymphocyte counts on histology, and celiac disease serology, all assessed at baseline and again at 12-months post-randomization. The proposed project will develop a U01 proposal for the M-RCT which will include a Clinical Protocol, Manual of Procedures, and detailed timeline and budget that documents study design and measures, training and protocol implementation, data handling, and dissemination of findings. The significance of this U34 work is to assure a M-RCT that is methodologically sound and ready to implement. If successful, the proposed future U01 intervention will improve mucosal recovery and quality of life, promote a shift in current practice of celiac disease management toward long-term monitoring, and represent a significant step toward reducing the severe physical and psychological consequences of celiac disease.