Patient perceptions of bioengineered probiotics and clinical metagenomics

描述（由申请人提供）：人类微生物组项目（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，为研究引入新的治疗方式时的伦理和社会考虑提供了独特的机会。迄今为止，对使用益生菌的伦理和社会考虑的分析集中在"非处方"应用上，其中医生参与益生菌的选择和施用是有限的。随着新的益生菌疗法成为临床医生的武器库的一部分，重要的是要考虑患者如何看待和应对医生推荐的新益生菌疗法。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必须得到很好的表征。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疗法的常见误解和/或可能限制患者对新治疗选择的热情的担忧。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。该项目的经验性结果将提交给胃肠病学，生物医学伦理，卫生政策和患者宣传方面的国家专家工作组，他们将确定促进负责任地将生物工程益生菌引入衰弱性胃肠道疾病患者护理的机会。这些战略将侧重于潜在的健康政策倡议和教育干预，胃肠病学家，患者教育者和非政府组织现在可以在生物工程益生菌疗法可能适合常规临床使用的时候进行预测。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。关于患者对人类微生物组项目促进的新兴治疗干预措施的态度和信念的系统数据至关重要，因为这些数据可以识别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选择的沟通。

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.