Evaluation of Novel Technologies to Improve Clinical Management of Celiac Disease: The GLUTECH Trial

改善乳糜泻临床管理的新技术评估：GLUTECH 试验

• 批准号: 10718458
• 负责人: Benjamin Lebwohl
• 金额: $ 128.82万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10718458
• 关键词: Address; Adherence; Adoption; Adult; Affect; Anemia; Antibodies; Anxiety; Autoantibodies; Awareness; Behavioral; COVID-19 pandemic; Celiac Disease; Chemistry; Clinical; Clinical Management; Clinical Trials; Communication; Complement; Consumption; Country; Detection; Diagnosis; Dietitian; Digestive System Disorders; Disease Management; Eating Behavior; Effectiveness; Evaluation; Fatigue; Food; Gastroenterology; Gliadin; Gluten; Gluten-free diet; Grant; Health; Health Professional; Height; Histology; Home; Illinois; Immune System Diseases; Immunoglobulin A; Immunoglobulin G; Incidence; Individual; Infertility; Infrastructure; Intervention; Link; Lymphocyte Count; Malignant Neoplasms; Massachusetts; Measures; Mediator; Mental Depression; Monitor; Morbidity - disease rate; Motivation; Mucous Membrane; National Institute of Diabetes and Digestive and Kidney Diseases; New York; Newly Diagnosed; Osteoporosis; Outcome; Outcome Study; Participant; Pathway interactions; Patient-Focused Outcomes; Patients; Peptide antibodies; Peptides; Performance; Persons; Physicians; Pisum sativum; Population; Quality of life; Randomized; Randomized, Controlled Trials; Recommendation; Recovery; Regimen; Sample Size; Sampling; Serology; Seroprevalences; Serum; Social support; Symptoms; Technology; Telemedicine; Tennessee; Testing; Tissue Transglutaminase Antibodies; Translating; United States; Urine; Videoconferencing; Villus; acceptability and feasibility; antigen test; clinical development; comparative cost effectiveness; cost; cost comparison; cost effective; cost effectiveness; deamidation; dietary; dietary adherence; effectiveness evaluation; effectiveness testing; follow-up; gastrointestinal symptom; immunogenic; improved; intraepithelial; meetings; mortality; new technology; novel; pandemic disease; portability; primary endpoint; primary outcome; psychologic; rapid testing; recruit; secondary outcome; sensor; social; standard of care; tool; validation studies

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. This U01 proposal is 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 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. If the primary endpoint of this proposed U01 is met, the intervention will improve mucosal recovery, 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.

项目摘要 拟议的项目解决了需要一个严格的试验，以测试新的面筋检测的有效性 作为远程医疗的辅助手段来管理成人腹腔疾病。乳糜泻影响约1% 美国（U.S.）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， 诊断率持续上升。发病可能很严重，包括贫血、不育、骨质疏松， 和恶性肿瘤，这可能会增加全因死亡率。唯一被证实的疗法是严格的无麸质饮食， 其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，许多乳糜泻患者 疾病根本看不到一个或只有一个单一的会话后立即诊断。COVID-19疫情 促进了远程医疗在胃肠病学中的快速采用，并可以促进 病人和营养师，消除了需要安排面对面的会议，在腹腔疾病中心， 可能在很远的地方。利用新技术进行自我监测，检测食品中的麸质（例如，便携式面筋 传感器）和尿液（例如，谷蛋白免疫原性肽试剂盒）可以促进对谷蛋白的更大的个体意识 暴露，是商业上提供给公众，并已被证明是有效和可靠的。医生 营养师们被问到是否应该使用这些技术，我们的初步研究表明， 证明了可接受性和可行性，但它们对临床结局的影响，如粘膜恢复和 症状尚未确定。本U 01提案针对多中心（纽约、马萨诸塞州、伊利诺伊州， 田纳西州）随机对照试验（M-RCT），以评估谷蛋白的有效性和文件成本 检测技术作为远程医疗的辅助手段， 诊断为乳糜泻的患者。受试者将随机接受1）标准治疗（即 一次面对面的营养师会议加上远程医疗营养师随访;或2）护理标准+麸质 检测技术。这将是第一个大规模的临床试验，以测试自我监测的效果， 麸质检测技术在乳糜泻管理中的应用。主要结局为粘膜恢复 12-随机化后个月。次要结局包括胃肠道症状、饮食 依从性、生活质量（包括焦虑和抑郁）、饮食行为、上皮内淋巴细胞计数 组织学和乳糜泻血清学，均在基线和随机化后12个月再次评估。 如果达到了该拟定U 01的主要终点，则干预将改善粘膜恢复，促进 目前腹腔疾病管理实践向长期监测的转变， 这是减少乳糜泻严重的生理和心理后果的一步。