Developing Probiotics as Foods and Drugs - Scientific and Regulatory Challenges

开发益生菌作为食品和药物 - 科学和监管挑战

• 批准号: 7164547
• 负责人: Patricia L Hibberd
• 金额: $ 3.71万
• 依托单位: TUFTS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7164547
• 关键词: biotherapeutic agent; drug design /synthesis /production; food; meeting /conference /symposium; travel

DESCRIPTION (provided by applicant): Fermented foods produced by "friendly" microbial organisms, or "probiotics," have been used historically to promote and sustain human and animal health. Probiotics are defined as live microorganisms (such as the bacteria species Lactobacillus and Bifidobacterium, and yeasts) with beneficial effects on the host. In contrast to "antibiotics," ("against life"), the term "probiotics" comes from the Greek meaning "for life." Much of the world uses fermented foods as dietary staples. Foods containing probiotic organisms include: milk, buttermilks, yogurt, infant formulas, fruit drinks, cheese, sour-dough, and various forms of fermented whey- based drinks. Today, in addition to their traditional uses to sustain and promote health, probiotics are being studied to determine their effects on diseases such as diarrheal disease, cancer, HIV-infection, cystic fibrosis, asthma, and inflammatory bowel disease. The Drug Information Association (DIA), a Pennsylvania- based nonprofit educational organization (www.diahome.org), is sponsoring a Workshop "Developing Probiotics as Foods and Drugs --Scientific and Regulatory Challenges" to take place in Washington, DC on October 16 and 17, 2006. The program will be chaired by Patricia Hibberd, MD, PhD, Tufts-New England Medical Center, James Heimbach, PhD, JHeimbach, LLC, Washington, DC and Freddie Ann Hoffman, MD, Heterogeneity LLC, Washington, DC. The purpose of the Workshop is to review/build on the current level of scientific evidence to determine what additional research may be needed to support the use of probiotics to promote and sustain health and in the management of disease conditions. Participants will discuss the limitations and gaps in the current body of evidence, as well as scientific and regulatory hurdles, and will provide recommendations regarding future areas in need of research support. Program sponsors and speakers include: the NIH National Center for Complementary and Alternative Medicine and Office of Dietary Supplements, National Academy of Sciences, International Scientific Association of Probiotics and Prebiotics, American Society for Microbiology, Canadian Research and Development Centre for Probiotics, and the FDA Center for Biologics Evaluation and Research (CBER) and FDA Center for Food Safety and Applied Nutrition (CFSAN). The DIA will manage the Workshop. The proceedings will be published in a peer-reviewed journal. Continuing Education credits will be offered to health professionals. An NIH Conference Grant is being requested for supplemental funding to support the travel of key US based workshop faculty and support of publication expenses.

描述（由申请人提供）：由“友好”微生物或“益生菌”生产的发酵食品在历史上已用于促进和维持人类和动物健康。益生菌被定义为活微生物（例如细菌种类乳杆菌和双歧杆菌，以及酵母菌），对宿主具有有益的作用。与“抗生素”（“反对生命”）相反，“益生菌”一词来自希腊语“生命”。世界上大部分地区都将发酵食品作为饮食主食。含有益生菌的食物包括：牛奶，酪乳，酸奶，婴儿配方，果实饮料，奶酪，酸面团和各种形式的发酵乳清饮料。如今，除了维持和促进健康的传统用途外，还研究了益生菌，以确定其对疾病，癌症，癌症，HIV感染，囊性纤维化，哮喘和炎症性肠病等疾病的影响。药物信息协会（DIA）是宾夕法尼亚州的非营利性教育组织（www.diahome.org），正在赞助一个“开发益生菌作为食品和药物 - 科学和监管挑战的研讨会 - - 2006年10月16日至17日，将在华盛顿州举行。中心，James Heimbach，博士，Jheimbach，LLC，华盛顿特区和Freddie Ann Hoffman，医学博士，异质性LLC，华盛顿特区。研讨会的目的是审查/建立基于当前的科学证据水平，以确定支持益生菌使用益生菌以促进和维持健康以及在疾病状况的管理中所需的其他研究。参与者将讨论当前证据体系以及科学和监管障碍的局限性和差距，并将提供有关需要研究支持的未来领域的建议。计划赞助商和演讲者包括：NIH国家补充和替代医学中心以及饮食补充剂办公室，国家科学院，国际益生菌和益生元科学协会，美国微生物学学会，加拿大益生菌研究与开发中心，加拿大研究与开发中心，FDA生物学评估和研究中心（CBER）和FDA Nutrition和FDA Nutrition和FDA Nutrition和FDA Nutrition（CFA）。 DIA将管理研讨会。程序将在经过同行评审的期刊上发布。继续教育学分将提供给卫生专业人员。 NIH会议赠款被要求提供补充资金，以支持美国主要的研讨会教师的旅行和对出版费用的支持。