CIH Practitioner Mentorship in Translational Clinical Research

项目摘要 母研究Xanthohumol Microbiome and Signature（XMaS）是一项由RO 1资助的多项主要研究。 FDA批准的临床试验，今年早些时候完成了第一阶段的临床操作。的 第一阶段试验旨在确定由黄腐酚（XN）制成的天然产品的安全性和耐受性， 在健康的成年人身上发现的啤酒花中的一种化合物。除了评估安全性外，合作者还 来自俄勒冈州州立大学的试验也将产生关于XN代谢物及其对生物标志物的影响的数据， 炎症和肠道完整性，太平洋西北国家实验室的合作者将确定 通过测序和代谢组学分析XN对微生物群的影响。这些数据将被 用作克罗恩病2期临床试验的比较数据，该试验于2009年9月开始招募， 2020年16日。兰利博士第二年行政补助的额外支持将允许 继续培训机会，博士后，早期职业补充和综合健康（CIH） 临床医生：1.通过参与操作性临床试验， 积极的临床试验的各个方面，同时在经验丰富的团队的领导和指导下， 研究人员; 2。获得在翻译中使用的科学方法和技术的曝光和指导， 多PI团队的协作实验室; 3.鼓励技术写作技能的发展， 介绍、出版和统计分析; 4.培养生物统计学、流行病学和 临床试验方法通过教学课程。将通过培训候选人启动试验参与 在临床筛查和其他访问中，包括：收集调查数据和生物标本，以及不良反应 事件报告，如试验方案所述。候选人还将接触特定的检测，包括 在试验中，例如微生物群测序和代谢组学分析，通过轮换的实践经验， 在每个合作实验室。最后，将在生物统计，演示和未来的出版物的技能发展 通过完成目前正在制定的范围界定审查、生物统计学和流行病学课程作业， 继续手稿开发，并在我们的指导下进行二级数据分析 常驻生物统计学家随着他第一年培训的顺利完成，第二年的支持， 博士兰利将提供宝贵的经验，因为他变得更有竞争力的未来培训奖项，在临床 和翻译研究。

Project Summary The parent study, Xanthohumol Microbiome and Signature (XMaS), is a RO1-funded, multiple principal investigator-led, FDA-approved clinical trial that completed its Phase 1 clinical operation earlier this year. The Phase 1 trial aimed to determine the safety and tolerability of a natural product made from xanthohumol (XN), a compound found in Humulus lupulus (hops), in healthy adults. In addition to assessing safety, collaborators on the trial from Oregon State University will also generate data on XN metabolites and its effects on biomarkers of inflammation and gut integrity, and collaborators at the Pacific Northwest National Laboratory will determine the effects of XN on the microbiota through sequencing and metabolomics profiling. Collectively, these data will be used as comparison data for the Phase 2 clinical trial in Crohn’s Disease, which began recruitment on September 16th, 2020. The additional support of a second-year administrative supplement for Dr. Langley will allow for continued training opportunity for a post-doctoral, early-career Complementary and Integrative Health (CIH) clinician by: 1. Building upon experience in the conduct of clinical trials through participation in the operational aspects of an active clinical trial while under the leadership and mentorship of an experienced team of researchers; 2. Gaining exposure and instruction on the translational scientific methods and techniques used in the collaborative laboratories of the multi-PI team; 3. Encouraging skill development in technical writing, presentation, publication, and statistical analysis; and 4. Developing skills in biostatistics, epidemiology, and clinical trial methodology through didactic coursework. Trial participation will be initiated by training the candidate in clinical screenings and other visits, including: collection of survey data and biologic specimens, and adverse event reporting, as outlined in the trial protocol. The candidate will also gain exposure to specific assays included in the trial, such as microbiota sequencing and metabolomic profiling, through hands-on experience with rotations in each collaborative lab. Finally, skills development in biostatistics, presentation, and future publication will be conducted by finalizing the scoping review currently in development, biostatistics and epidemiology coursework, continuing manuscript development, and performing secondary data analysis under the mentorship of our resident biostatistician. With the successful completion of his initial year of training, a second year of support for Dr. Langley will provide valuable experience as he becomes more competitive for future training awards in clinical and translational research.