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Grant Abstract

Grant Number: 1R13AT003805-01
Project Title: Developing Probiotics as Foods and Drugs - Scientific and Regulatory Challenges

Abstract: 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 (, 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.

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