CIH Practitioner Mentorship in Translational Clinical Research

项目摘要 母公司研究，黄腐酚微生物组和签名(XMAS)，是一项由RO1资助的多主体研究 由研究人员领导、FDA批准的临床试验于今年早些时候完成了第一阶段临床操作。这个 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， 在健康成年人的啤酒花中发现的化合物。除了评估安全性外，合作者还在 俄勒冈州立大学的这项试验还将产生关于XN代谢物及其对 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对微生物区系的影响。总的来说，这些数据将是 用作克罗恩病二期临床试验的对比数据，该试验于9月开始招募 2020年16日。兰利博士第二年行政补助金的额外支助将使 博士后、职业早期补充和综合健康(CIH)的持续培训机会 临床医生：1.通过参与临床试验，积累临床试验的经验 在有经验的团队的领导和指导下进行积极的临床试验的各个方面 研究人员；2.接触和指导翻译科学方法和技术 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；以及4.发展生物统计学、流行病学和 通过教学课程的临床试验方法论。参加试验将通过对候选人进行培训来开始 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 试验方案中概述的事件报告。候选人还将接触到特定的检测方法，包括 在试验中，例如微生物区系测序和代谢组谱分析，通过轮换的实践经验 在每个协作实验室中。最后，生物统计、演讲和未来出版方面的技能发展将是 通过最后确定目前正在进行的发展、生物统计和流行病学课程的范围审查， 继续手稿开发，并在我们的指导下进行二次数据分析 常驻生物统计师。随着他第一年的培训圆满完成，第二年的支持 兰利博士将提供宝贵的经验，因为他在未来的临床培训奖方面变得更具竞争力。 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.