Patient perceptions of bioengineered probiotics and clinical metagenomics

描述（由申请人提供）：人类微生物组计划（HMP）的启动，以及NIH新倡议可能产生的对生物工程益生菌疗法的相应兴趣，为研究在引入新治疗方式时检查伦理和社会考虑提供了独特的机会。迄今为止，对益生菌使用的伦理和社会考虑的分析主要集中在“非处方”应用上，其中医生参与益生菌的选择和管理是有限的。随着新的益生菌疗法成为临床医生武器库的一部分，重要的是要考虑患者如何感知和对医生推荐的新的益生菌疗法的反应。为了成功地整合到患者护理中，患者对生物工程益生菌的态度和信念得到很好的表征是至关重要的。对患者对治疗性益生菌的认知的研究可能会揭示对益生菌疗法的常见误解和/或广泛的担忧，这些误解可能会限制患者对新治疗选择的热情。该研究项目将描述患者对生物工程益生菌的看法以及人类微生物组宏基因组分析的其他潜在临床应用。该项目的实证结果将提交给一个由胃肠病学、生物医学伦理学、卫生政策和患者权益方面的国家专家组成的工作组，他们将确定机会，促进负责任地将生物工程益生菌引入衰弱性胃肠疾病患者的护理中。这些策略将侧重于潜在的卫生政策倡议和教育干预措施，胃肠病学家、患者教育者和自愿卫生组织现在可以采取这些措施，以预测生物工程益生菌疗法可能适合常规临床使用的时间。公共卫生相关性：本研究将检查患者对生物工程益生菌的看法以及人类微生物组宏基因组分析的其他潜在临床应用。人类微生物组计划促进了患者对新兴治疗干预措施的态度和信念的系统数据至关重要，因为这些数据可以确定将生物工程益生菌成功整合到患者护理中的潜在障碍，并改善医患之间关于新治疗方案的沟通。

DESCRIPTION (provided by applicant): The launch of the Human Microbiome Project (HMP), and the corresponding interest in bioengineered probiotic therapies that this new NIH initiative is likely to generate, provide a unique opportunity for research examining ethical and social considerations in the introduction of new therapeutic modalities. To date, analysis of ethical and social considerations in the use of probiotics have focused on "over the counter" applications where physician involvement in the selection and administration of the probiotic is limited. As new probiotic therapies become a part of the clinician's arsenel, it is important to consider how patients may perceive and respond to new probiotic therapies that are recommended by their physicians. To be successfully integrated into patient care, it is critical that patient attitudes and beliefs regarding bioengineered probiotics be well characterized. Studies of patient perceptions of therapeutic probiotics may reveal common misconceptions about probiotic therapies and/or widespead concerns that may limit patient enthusiasm for new therapeutic options. This research project will characterize patient perceptions of bioengineered probiotics and other potential clinical applications of metagenomic analyses of the human microbiome. Empirical results from the project will be presented to a Working Group of national experts in gastroenterology, biomedical ethics, health policy, and patient advocacy, who will identify opportunities to promote the responsible introduction of bioengineered probiotics into the care of patients with debilitating gastrointestinal diseases. These strategies will focus on potential health-policy initiatives and educational interventions that gastroenterologists, patient educators, and voluntary-health organizations can undertake now in anticipation of the time when bioengineered probiotic therapies may be appropriate for routine clinical use. PUBLIC HEALTH RELEVANCE: This research study will examine patient perceptions of bioengineered probiotics and other potential clinical applications of metagenomic analyses of the human microbiome. Systematic data on patient attitudes and beliefs about emerging therapeutic interventions facilitated by the Human Microbiome Project are critically important, as these data can identify potential barriers to the successful integration of bioengineered probiotics into patient care and improve physician-patient communication about new therapeutic options.