University of Illinois at Chicago Hemodialysis Opioid Prescription Effort (HOPE) Clinical Center

伊利诺伊大学芝加哥分校血液透析阿片类处方药物 (HOPE) 临床中心

基本信息

批准号：
10208052
负责人：
Ardith Z Doorenbos
金额：
$ 14.77万
依托单位：
UNIVERSITY OF ILLINOIS AT CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-24 至 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10208052
关键词：
Administrative Supplement Adult Affect Area Award Bacteria Benchmarking Brain Chicago Clinical Research Clinical Trials Collection DNA Data Collection Development Devices Dialysis procedure Doctor of Philosophy End stage renal failure Enrollment Feasibility Studies Feces Foundations Funding Genes Goals Grant Hemodialysis Home environment Illinois Intervention Investigation Knowledge Leadership Logistics Maintenance Manuscripts Nurses Oral Pain Pain Research Pain management Participant Patients Principal Investigator Procedures Protocols documentation Research Research Personnel Research Training Sampling Science Scientist Site Symptoms Temperature Time TimeLine Training United States National Institutes of Health Universities Visit Volatile Fatty Acids Writing career career development chronic pain clinical center clinical pain fecal microbiome gut microbiome gut microbiota interest member microbiome opioid use pain reduction prescription opioid programs recruit sample collection skills

项目摘要

Dr. Lockwood is a nurse scientist with a deep commitment to a research career in clinical pain research. The supplement will allow Dr. Lockwood to further his clinical research training with a focus on examining the relationship between the composition and function of the gut microbiome, including the symbiotic bacteria residing in the gut and their functional gene content, and chronic pain among adults with end-stage kidney disease (ESKD). Interest in how the microbiome influences psychoneurological symptoms, including pain, has been increasing in recent years but remains incompletely understood. Hence, further investigation into this area is needed. Examining how the brain-gut-microbiome affects chronic pain in ESKD patients is a natural extension of Dr. Lockwood’s current research program and represents an excellent opportunity for him to expand his skill set as a pain investigator. Dr. Lockwood’s short-term career development goals are: (1) Gain knowledge and research skills specifically focused on implementing and evaluating pain management interventions in adults with ESKD and chronic pain receiving maintenance hemodialysis. (2) Further develop scientific presentation, manuscript, and grant writing skills. (3) Cultivate the team leadership skills necessary for successful team science projects. (4) Explore the acceptability and feasibility of collecting feces to explore the gene content of the gut microbiota and short-chain fatty acids (SCFAs) among people with ESKD on maintenance hemodialysis before and after pain management interventions. The acceptability and feasibility study has two specific aims: Aim 1: Determine the acceptability of collecting feces. (Benchmark: 70% recruitment rate.) Aim 2: Determine the feasibility of fecal data collection procedures. (Benchmark: 80% of participants return fecal microbiome samples at all 4 time points.) The study will enroll 30 adult participants enrolled in the HOPE consortium trial at the UIC site. Microbiome samples will be collected at 12-week intervals that match the data collection procedures timeline outlined in the HOPE consortium trial protocol (i.e., baseline, week 12, week 24, week 36). Participants will be provided with a fecal collection kit (OmniGene Gut and OmniGene Oral sampling devices from DNA Genotek, which allow samples to be stored at room temperature for short and medium terms, necessary for home collection) and asked to collect a fecal sample and bring the sample to their next hemodialysis visit when they will be completing HOPE consortium trial data collection procedures. This acceptability and feasibility study will help determine the best strategies for recruiting research participants from multiple dialysis facilities, sample collection logistics, and protocols for collection and storage of metabolites (e.g., SCFAs). By conducting this study as principal investigator, Dr. Lockwood will also obtain new skills in leading a team science project, including managing team members and logistics for a multisite study, and the necessary foundation in clinical pain research to support his development as an independent clinical pain researcher.

Lockwood 博士是一名护士科学家，致力于临床疼痛研究的研究事业。补充品将使洛克伍德博士能够进一步开展他的临床研究培训，重点是检查肠道微生物组（包括共生细菌）的组成和功能之间的关系存在于肠道中的基因及其功能基因含量，与终末期肾病成人的慢性疼痛疾病（ESKD）。人们对微生物组如何影响包括疼痛在内的心理神经症状产生了兴趣。近年来一直在增加，但仍不完全了解，因此，对此进行了进一步的调查。研究脑-肠-微生物组如何影响 ESKD 患者的慢性疼痛是很自然的事情。洛克伍德博士当前研究计划的延伸，对他来说是一个绝佳的机会扩展洛克伍德博士作为疼痛调查员的技能，其短期职业发展目标是：(1) 获得收益。特别注重实施和评估疼痛管理的知识和研究技能（二）进一步发展 (3)培养必要的团队领导能力（4）探索收集粪便进行探索的可接受性和可行性。 ESKD 患者肠道微生物群和短链脂肪酸 (SCFA) 的基因含量疼痛管理干预前后维持性血液透析的可接受性和可行性。研究有两个具体目标：目标 1：确定收集粪便的可接受性（基准：70%）。招募率。）目标 2：确定粪便数据收集程序的可行性（基准：80%）。参与者在所有 4 个时间点返回粪便微生物组样本。）该研究将招募 30 名成年参与者参加 UIC 网站的 HOPE 联盟试验的微生物样本将在第 12 周时收集。与 HOPE 联盟试验方案中概述的数据收集程序时间表相匹配的间隔（即基线、第 12 周、第 24 周、第 36 周将为参与者提供粪便收集套件 (OmniGene Gut)。以及 DNA Genotek 的 OmniGene 口腔采样设备，可将样本保存在房间内短期和中期的温度，家庭收集所必需的）并要求收集粪便样本并在他们完成 HOPE 联盟试验数据时将样本带到下次血液透析就诊该收集程序的可接受性和可行性研究将有助于确定最佳策略。从多个透析设施、样本收集物流和协议中招募研究参与者代谢物（例如 SCFA）的收集和储存通过作为首席研究员进行这项研究，Dr. 洛克伍德还将获得领导团队科学项目的新技能，包括管理团队成员和多地点研究的后勤保障，以及支持其发展的临床疼痛研究的必要基础作为一名独立的临床疼痛研究员。