Ciencia

Supplemental Material can be found at:
http://jn.nutrition.org/content/suppl/2010/02/19/jn.109.11377
9.DC1.html

The Journal of Nutrition
Supplement: Guidance for Assessing Probiotics Beneficial Effects—How to Fill the GAP

Guidance for Substantiating the Evidence for
Beneficial Effects of Probiotics: Current Status
and Recommendations for Future Research1–3
Ger T. Rijkers,4 StigBengmark,5 Paul Enck,6 Dirk Haller,7 Udo Herz,8 Marko Kalliomaki,9 Satoshi Kudo,10
Irene Lenoir-Wijnkoop,11 Annick Mercenier,12 Eveliina Myllyluoma,13 Sylvie Rabot,14 Joseph Rafter,15
Hania Szajewska,16 Bernhard Watzl,17 Jerry Wells,18 Danielle Wolvers,19 and Jean-Michel Antoine20
4

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Department of Surgery, University Medical CenterUtrecht, and Department of Medical Microbiology and Immunology, St. Antonius
Hospital, Nieuwegein, The Netherlands; 5University College London, London, United Kingdom; 6Department of Internal Medicine VI,
University Hospital, Tubingen, Germany; 7Chair for Biofunctionality, ZIEL-Research Center for Nutrition and Food Science,
¨
Technische Universitat Munchen, Freising-Weihenstephan, Germany; 8Researchand Development, Mead Johnson Nutrionals a
¨
¨
Bristol-Myers Squibb Company, Evansville, IN; 9Department of Paediatrics, University of Turku, Turku, Finland; 10Yakult Europe,
Almere, The Netherlands; 11International Dairy Federation FIL-IDF, Paris, France; 12Allergy Group, Nutrition and Health Department,
Nestle Research Center, Lausanne, Switzerland; 13Valio Ltd., Research Centre, Helsinki,Finland and Institute of Biomedicine,
´
Pharmacology, University of Helsinki, Helsinki, Finland; 14INRA, UR 910 Ecology and Physiology of the Digestive Tract, F-78350
Jouy-en-Josas, France; 15Department of Medical Nutrition, Karolinska Institute, Huddinge, Sweden; 16The Medical University of
Warsaw, Warsaw, Poland; 17Department of Physiology and Biochemistry of Nutrition, MaxRubner-Institute, Karlsruhe, Germany;
18
Department of Host-Microbe Interactomics, University of Wageningen, Wageningen, The Netherlands; 19Unilever Food & Health
Research Institute, Vlaardingen, The Netherlands; and 20Danone Research Center, Palaiseau, France

Abstract
Probiotic bacteria are live microorganisms that, when administered in adequate amounts, confer a health benefit on the
host. There is agrowing interest in probiotics within the scientific community, with consumers, and in the food industry.
The interactions between the gut and intestinal microbiota and between resident and transient microbiota define a new
arena in physiology, an understanding of which would shed light on the “cross-talk” between humans and microbes. The
different beneficial effects of specific probiotic strains maybe translated into different health claims. However, there is a
need for comprehensive and harmonized guidelines on the assessment of the characteristics and efficacy of probiotics
and of foods containing them. An international expert group of ILSI has evaluated the published evidence of the
functionality of different probiotics in 4 areas of (human) application: 1) metabolism, 2) chronicintestinal inflammatory and
functional disorders, 3) infections, and 4) allergy. Based on the existing evidence, concrete examples of demonstration of
benefits and gaps are listed, and guidelines and recommendations are defined that should help design the next generation
of probiotic studies. J. Nutr. 140: 671S–676S, 2010.

Introduction
Probiotics are defined as live microorganisms that, whenadministered in adequate amounts, confer a health benefit on
the host (1). The first written documentation of the healthpromoting effect of probiotics can be found in the Persian bible,

in which Genesis 18:8 states that Abraham owned his longevity
to the daily consumption of fermented milk products. The
scientific literature on probiotics starts with Metchnikoff (2),
which incidentally also dealt...