Characterization and Clinical Course of Symptoms and Gastric Emptying in Pediatric Participants with Symptoms of Gastroparesis

家长奖摘要 NIDDK（National Institute of Diabetes and Digestive and Kidney Diseases） 胃轻瘫登记3：症状和胃轻瘫的特征和临床病程 胃轻瘫患者的排空 背景：NIH GpCRC产生了大量胃轻瘫（GP） 相关的研究，这增加了我们的知识和理解这一概念， 条件，其并发症，诊断挑战和临床结果。最新 这项研究被称为胃轻瘫登记3（GpR 3），现在被认为是父母 项目/奖项（联邦标识符：DK 74035）。 GpR 3的目的是：1）扩大流行病学研究的患者登记， 病因学和与胃轻瘫相关的发病程度。2)继续跟踪和 3）为招募具有良好特征的 用于治疗性临床试验的GP患者，病理生理学、分子学、组织病理学，或 其他辅助研究。 方法：我们纳入了糖尿病、特发性和尼森胃底折叠术后胃轻瘫 胃排空延迟和正常的患者。TTUHSC EP能够招募104名 400名受试者。基线数据收集包括人口统计学、社会经济 特征和捕获方案要求的信息的所有测量。2020年 实施COVID-19研究，以评估COVID-19是否与 感染后GP的发展。 结果：母项目，胃轻瘫登记3（GpR 3），仍然是一个积极的研究， 从合格和已入组的具有以下症状的患者中收集数据- 胃轻瘫流行病学、临床、生理和患者结局数据正在 收集患者的特征和他们的临床过程，以更好地了解这种疾病。 长期目标是帮助患者进入病理生理学定义的亚群表型。这 分类将为翻译研究提供基础，便于搜索 病因并最终增强定义和进行大型临床试验的能力 从而开发出更合理有效的治疗方法， 胃轻瘫GpR 3招募了18岁及以上的患者。新的子项目， 儿科胃轻瘫登记研究2（PGpR 2）旨在评估患者的相同目标 年龄在8岁至24岁之间，在儿科GI多中心诊所就诊。 关于这项儿科研究的详细信息见所附的资助申请， 指定PI/PD McCallum博士和Sarosiek博士为主管和导师，负责 儿科GI PI弗朗西斯博士的咨询作用和结局以及研究的开展。

Summary/ Abstract of Parent Award Title: The NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases) Gastroparesis Registry 3: Characterization and Clinical Course of Symptoms and Gastric Emptying in Patients with Symptoms of Gastroparesis Background: The NIH GpCRC has generated an extensive number of gastroparesis (GP) related studies, which have increased our knowledge and concepts of understanding of this condition, its complications, diagnostic challenges and clinical outcomes. The most current study was called The Gastroparesis Registry 3 (GpR 3), which now is recognized as a Parent Project/Award (Federal Identifier: DK74035). Objectives of GpR3 are: 1) To expand a registry of patients for the study of the epidemiology, etiology, and degree of morbidity associated with gastroparesis. 2) To continue to follow and expand the data collections 3) To provide a reliable source for recruitment of well-characterized patients with GP for therapeutic clinical trials, pathophysiological, molecular, histopathologic, or other ancillary studies. Methods: We enrolled diabetic, idiopathic and post-Nissen fundoplication gastroparesis patients with delayed and normal gastric emptying. TTUHSC EP was able to enrolled 104 out of 400 participating subjects. Baseline data collection included demographic, socioeconomic characteristics and all measures capturing information requested by the protocol. In 2020 COVID-19 study was implemented to assess whether COVID-19 is associated with development of post-infection GP. Results: The parent project, Gastroparesis Registry 3 (GpR3), is still an active study that collects data from qualified and already enrolled patients with symptoms of and like- gastroparesis. Epidemiological, clinical, physiological, and patient outcome data is being collected to characterize the patients and their clinical course to better understand this disorder. The long-term goal is to help phenotype patients into pathophysiologically defined subsets. This classification will provide a foundation for translational research, facilitating the search for etiopathogenesis and enhance the ability to define and conduct large clinical trials, ultimately leading to the development of more rational and effective therapeutic approaches for gastroparesis. GpR3 recruited patients who are 18 years of age and older. The new sub-project, The Pediatric Gastroparesis Registry2 (PGpR2), aims to assess the same objectives in patients between the ages of 8 and 24 years old, who are seen in the pediatric GI multicenter clinics. Specifics on this pediatric study are presented in an attached grant application, which designated PI/PDs Dr. McCallum and Dr Sarosiek as supervisors and mentors responsible for the advisory role and outcomes of Dr Francis, Pediatric GI PI, and conduct of the study.