CIH Practitioner Mentorship in Translational Clinical Research

项目摘要 母研究，黄腐酚微生物组和签名（XMaS）在健康成人，是一个RO 1资助的，多个 FDA批准的主要药物领导的1期临床试验，旨在确定安全性和耐受性 黄腐酚（XN）是一种在啤酒花中发现的化合物， 成年人了除了评估安全性，来自俄勒冈州州立大学的试验合作者还将产生 关于XN代谢物及其对炎症和肠道完整性的生物标志物的影响的数据。此外，合作者 太平洋西北国家实验室的研究人员将通过以下方式确定XN对微生物群的影响： 测序和代谢组学分析。总之，这些数据将用作 随后在克罗恩病成人中进行2期临床试验。母项目正在积极招募， 招募参与者，并将在2020年全年这样做。一个行政部门的额外支持 补充将允许一个独特的培训机会，为博士后，早期职业补充和 综合健康（CIH）临床医生：1。通过参与提供临床试验实施经验 在积极的临床试验的操作方面，同时在经验丰富的 研究人员; 2。支持独特的接触和指导转化的科学方法， 在多PI团队的实验室中使用的技术;以及3.鼓励生物统计方面的技能发展， 介绍和出版。将通过对候选人进行临床筛选培训来启动试验参与 和其他访视，包括：收集调查数据和生物标本，以及不良事件报告， 在试验方案中概述。候选人还将接触试验中包括的特定检测试剂盒，例如 作为微生物群测序和代谢组学分析，通过在每个领域的轮换实践经验， 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 通过系统性审查、生物统计学课程作业、进行 预先存在的数据，并参与系统性综述撰写团队。虽然参与的最初一年是 预计将在实现这些目标方面取得可衡量的进展，第二年的支持将使 将培训扩展到母研究的其他阶段。

Project Summary The parent study, Xanthohumol Microbiome and Signature (XMaS) in Healthy Adults, is a RO1-funded, multiple principal investigator-led, FDA-approved Phase 1 clinical trial which aims 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. Additionally, 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 a subsequent Phase 2 clinical trial in adults with Crohn’s Disease. The parent project is actively recruiting and enrolling participants, and will be doing so throughout 2020. The additional support of an administrative supplement will allow for a unique training opportunity for a post-doctoral, early-career Complementary and Integrative Health (CIH) clinician by: 1. Providing 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. Supporting unique exposure and instruction on the translational scientific methods and techniques used in the laboratories of the multi-PI team; and 3. Encouraging skill development in biostatistics, presentation and publication. 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 through training in systematic reviews, biostatistics coursework, performing an ancillary analysis of pre-existing data and participating in a systematic review writing team. While an initial year of participation is expected to produce measurable progress toward these aims, a second year of support would enable an extension of training into additional stages of the parent study.