Changes in Oral and Gut Microbiota and Incidence and Severity of Patient-Reported Symptoms in Pre- and Post-Kidney Transplant Patients

肾移植前后患者口腔和肠道微生物群的变化以及患者报告症状的发生率和严重程度

• 批准号: 10024086
• 负责人: Mark Lockwood
• 金额: $ 16.19万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-25 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10024086
• 关键词: 16S ribosomal RNA sequencing; Address; Affect; Age; Antibiotics; Antiviral Agents; Anxiety; Awareness; Bacteria; Birth; Cesarean section; Cessation of life; Chemicals; Chronic Kidney Failure; Communication; Communities; Complete Blood Count; Confounding Factors (Epidemiology); Creatinine; Data; Development; Dietary History; Dietary Intervention; Disease; Education; Ethnic Origin; Etiology; Exposure to; Family; Fatigue; Feces; Gastrointestinal tract structure; Gender; Gene Components; Genes; Glomerular Filtration Rate; Goals; Graft Rejection; Health; Human; Immunologics; Immunosuppression; Immunosuppressive Agents; Incidence; Income; Individual; Infection; Inflammatory; Intervention; Kidney Diseases; Kidney Transplantation; Life Style Modification; Link; Living Donors; Longitudinal Studies; Measurement; Measures; Mental Depression; Metabolic; Methods; Mission; Monitor; National Institute of Nursing Research; Nature; Neurotransmitters; Nurses; Nutritional status; Operative Surgical Procedures; Oral; Oral cavity; Organism; Outcome; Outcome Measure; Participant; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Phenotype; Process; Production; Prospective cohort study; Proteobacteria; Quality of life; Questionnaires; Race; Regimen; Renal function; Reporting; Research; Resolution; Sampling; Sampling Studies; Schedule; Severities; Shotguns; Sleep; Sleep Disorders; Sleep disturbances; Sputum; Structure; Symptoms; System; Tacrolimus; Taxonomy; Time; Transplant Recipients; Transplantation; Transplantation Surgery; Vagina; anxiety symptoms; beta diversity; cytokine; delayed graft function; design; diet and exercise; disabling symptom; experience; fecal microbiota; gut microbiome; gut microbiota; gut-brain axis; health related quality of life; improved; innovation; medication compliance; medication nonadherence; metagenomic sequencing; microbial community; microbiome; microbiome alteration; microbiome sequencing; microbiota; multidisciplinary; novel; novel strategies; oral microbial community; oral microbiome; personalized medicine; post-transplant; probiotic supplementation; prospective; reduce symptoms; restoration; symptom cluster; symptom science

Abstract This novel prospective cohort study will explore the relationship between kidney transplantation (antibiotics, antivirals, and immunosuppressants), changes in the composition and functional gene content of the microbiome, and the incidence and severity of patient reported symptoms before and after patients receive a kidney transplant from a live donor. We have selected living donor recipients to reduce the chance of missing samples, as these are scheduled surgeries. Thirty-nine subjects will provide stool and sputum samples for shot gun metagenomic sequencing of the microbiome before transplant, during the first week after transplant prior to discharge, and at 3 months after the transplant. Demographic (age, gender, race/ethnicity, income, education) and disease specific data (HT/WT/BMI, creatinine, estimated glomerular filtration rate, basic metabolic panel, complete blood count), and medication adherence data (electronic medication adherence monitoring and tacrolimus trough levels) will be collected. Potential confounding variables will include: historical use of antibiotics, concomitant medications, mode of delivery (vaginal vs. caesarian birth), and nutritional status (Diet History Questionnaire III). Incidence and severity of symptoms of fatigue, sleep dysfunction, and anxiety/depression–like symptoms will be measured using the Patient Reported Outcome Measurement Systems (PROMIS) 57 v2.1. Health related quality of life will be assessed using the Kidney Disease Quality of Life Short Form (KDQOL-SF v1.3). This research will support the mission of the National Institute of Nursing Research (NINR) to promote and improve the health and quality of life of individuals, families, and communities. The proposed study will contribute to the NINR mission by: 1) Exploring the mechanisms underlying incidence and severity of symptoms after kidney transplantation with the goal of developing personalized treatments, including pre-probiotics supplementation, lifestyle modification, and dietary interventions that address these mechanisms through symptom science research; 2) Helping individuals with chronic kidney disease/kidney transplant recipients better understand and manage these conditions by engaging individuals as active participants in managing their own health through awareness of modifiable factors that alter the microbiome; and 3) Promoting the development of innovative, multidisciplinary, nurse-led teams to advance research on microbiome and health after kidney transplantation.

摘要 这项新的前瞻性队列研究将探讨肾移植（抗生素， 抗病毒药物和免疫抑制剂），组成和功能基因含量的变化， 微生物组，以及患者接受治疗前后患者报告的症状的发生率和严重程度 活体肾脏移植我们已经选择了活体捐赠接受者，以减少遗漏的机会 样本，因为这些是预定的手术。39名受试者将提供粪便和痰液样本用于注射 在移植前、移植后第一周、移植前和移植后第二周， 到出院，以及移植后3个月。人口统计（年龄、性别、种族/民族、收入、 受教育程度）和疾病特异性数据（HT/WT/BMI、肌酐、估计肾小球滤过率、基础 代谢组、全血细胞计数）和药物依从性数据（电子药物依从性 监测和他克莫司谷浓度）。潜在混杂变量包括：历史 抗生素的使用、合并用药、分娩方式（阴道分娩vs.剖腹产）和营养 状态（饮食史问卷III）。疲劳、睡眠功能障碍和 将使用患者报告结果测量来测量焦虑/抑郁样症状 系统（PROMIS）57 v2.1.健康相关生活质量将使用肾脏疾病质量评估。 生活质量简表（KDQOL-SF v1.3）。这项研究将支持国家护理研究所的使命 研究（NINR），以促进和改善个人，家庭和家庭的健康和生活质量， 社区.拟议的研究将有助于NINR的使命：1）探索机制 肾移植后症状的潜在发病率和严重程度， 个性化治疗，包括益生菌前补充剂，生活方式改变，饮食 通过症状科学研究解决这些机制的干预措施; 2）帮助个人 慢性肾病/肾移植受者通过以下方式更好地了解和管理这些疾病 让个人积极参与管理自己的健康， 改变微生物组的因素;和3）促进创新，多学科，护士主导的发展 团队推进肾移植后微生物组和健康的研究。