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，以及这一新的NIH倡议可能产生的对生物工程益生菌疗法的相应兴趣，为研究在引入新的治疗方式时审查伦理和社会考虑因素提供了一个独特的机会。到目前为止，对使用益生菌的伦理和社会考虑因素的分析主要集中在医生参与益生菌的选择和管理的“非处方”应用。随着新的益生菌疗法成为临床医生阿尔谢尔的一部分，重要的是考虑患者可能如何看待和回应他们的医生推荐的新的益生菌疗法。为了成功地融入患者护理，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看法的研究可能会揭示对益生菌治疗的常见误解和/或广泛的担忧，这可能会限制患者对新的治疗选择的热情。这项研究项目将描述患者对生物工程益生菌的感知以及人类微生物组的元基因组分析的其他潜在临床应用。该项目的经验结果将提交给胃肠病学、生物医学伦理、卫生政策和患者倡导方面的国家专家工作组，工作组将确定机会，促进将生物工程益生菌负责任地引入到虚弱的胃肠道疾病患者的护理中。这些战略将把重点放在潜在的卫生政策倡议和教育干预上，胃肠学家、患者教育工作者和志愿健康组织现在可以进行，以预期生物工程益生菌疗法可能适合用于常规临床的时候。公共卫生相关性：这项研究将检查患者对生物工程益生菌的感知以及人类微生物组的元基因组分析的其他潜在临床应用。在人类微生物组项目的推动下，关于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成功将生物工程益生菌整合到患者护理中的潜在障碍，并改善关于新治疗方案的医患沟通。

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.