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Potential Uses of Probiotics in Clinical Practice Gregor Reid,1,2,3* Jana Jass,1,2 M

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Potential Uses of Probiotics in Clinical Practice Gregor Reid,1,2,3* Jana Jass,1,2 M CLINICAL MICROBIOLOGY REVIEWS, Oct. 2003, p. 658–672 Vol. 16, No. 4 0893-8512/03/$08.00ϩ0 DOI: 10.1128/CMR.16.4.658–672.2003 Copyright © 2003, American Society for Microbiology. All Rights Reserved. Potential Uses of Probiotics in Clinical Practice Gregor Reid,1,2,3* Jana Jass,1,2 M. Tom Sebulsky,2 and John K. McCormick1,2 Canadian Research and Development Centre for Probiotics, The Lawson Health Research Institute, London, Ontario N6A 4V2,1 and Departments of Microbiology and Immunology2 and Surgery,3 University of Western Ontario, London, Ontario N6A 5C1, Canada INTRODUCTION .......................................................................................................................................................658 PRESENT STATUS OF PROBIOTICS IN CLINICAL PRACTICE...................................................................658 EVIDENCE OF PROBIOTIC EFFECTIVENESS..................................................................................................659 Probiotics for Newborns and Children................................................................................................................659 HOW PROBIOTICS REDUCE THE DURATION OF DIARRHEA...................................................................660 ADDITIONAL APPLICATIONS OF ORAL PROBIOTICS .................................................................................662 Bacterial Gastroenteritis........................................................................................................................................662 Helicobacter pylori Infections and Complications ...............................................................................................663 Inflammatory Diseases and Bowel Syndromes ...................................................................................................663 Cancer ......................................................................................................................................................................664 Mucosal Immunity..................................................................................................................................................664 Allergy.......................................................................................................................................................................664 WOMEN؅S REPRODUCTIVE AND BLADDER HEALTH..................................................................................664 PROBIOTICS FOR SURGICAL INFECTIONS ....................................................................................................666 GUIDELINES FOR THE EVALUATION OF PROBIOTICS ..............................................................................666 Strain Identification ...............................................................................................................................................666 In Vitro and In Vivo Experiments........................................................................................................................667 Safety ........................................................................................................................................................................668 Phase 2 Clinical Studies ........................................................................................................................................668 Phase 3 Clinical Studies ........................................................................................................................................668 Health Claims and Labeling .................................................................................................................................669 THE WAY FORWARD...............................................................................................................................................669 ACKNOWLEDGMENTS ...........................................................................................................................................669 REFERENCES ............................................................................................................................................................669 INTRODUCTION isms. In addition, although clinical evidence of the tangible benefits of probiotics is mounting, this does not yet reflect the The term probiotic was derived from the Greek, meaning commercial front. Unfortunately, many so-called probiotic “for life.” The Food and Agriculture Organization of the products have not been properly identified, documented, man- United Nations (FAO) and the World Health Organization ufactured under good manufacturing practices, or proven clin- (WHO) have stated that there is adequate scientific evidence ically, yet various companies make claims that lead consumers to indicate that there is potential for probiotic foods to provide and caregivers to believe that they are using reliable products. health benefits and that specific strains are safe for human use Thus, the establishment of standards and guidelines represents (38). An expert panel commissioned by FAO and WHO de- a necessary first step in making sure that probiotic products are fined probiotics as “Live microorganisms which when admin- indeed legitimate and effective. Such standards and guidelines istered in adequate amounts confer a health benefit on the have recently been generated and will be presented later. host.” This is the definition that should be used, and probiotics should not be referred to as biotherapeutic agents (84). Probiotics represents an expanding research area. A Med- PRESENT STATUS OF PROBIOTICS IN CLINICAL line search of the term probiotics illustrates the significant PRACTICE increase in research undertaken in this area during the past 5 It is important to first examine the present status of probi- years: over 1,000 publications cited, compared to 85 for the otics in clinical practice and the evidence of their effects. In previous 25 years. While this demonstrates the potential sig- general, probiotics are not a mainstay of clinical practice in nificance of this emerging field, much still remains to be done North America. For example, an analysis by a high school to standardize the meaning of the term probiotic and which student of physician practices in a small Canadian city showed strains actually fulfill the criteria of true probiotic microorgan- that only 31% had any knowledge of probiotics and 24% felt that probiotics had no place in their practices (34). The 31% figure may be much higher in many parts of the Western world, * Corresponding author. Mailing address: Canadian Research and and of those who have knowledge, the accuracy of their infor- Development Centre for Probiotics, Lawson Health Research Insti- tute, 268 Grosvenor Street, London, Ontario N6A 4V2, Canada. mation may also be flawed. For example, by definition, yogurt Phone: (519) 646-6100, x65256. Fax: (519) 646-6031. E-mail: gregor per se is not a probiotic, and many so-called acidophilus prod- @uwo.ca. ucts have never been tested and do not fulfill the FAO and 658 VOL. 16, 2003 PROBIOTICS FOR CLINICAL PRACTICE 659 WHO criteria for probiotics (37). The fact that 76% of physi- third to one half of all very low birth weight infants (47). Of cians believed that probiotics could have a place in their pa- those, approximately half will require surgery. The mortality tient management implies the potential of this approach as ranges from 20 to 30%, and of those who survive, approxi- well as inadequacies felt by physicians in their current treat- mately 25% experience long-term sequelae, such as short gut ment arsenal. syndrome and intestinal obstruction. In some cases, the se- Many health care professionals such as holistic practitioners, quelae result from multisystem organ failure that has damaged naturopaths, chiropractors, and herbalists routinely use prod- the lungs or other organs. ucts perceived to contain lactobacilli, bifidobacteria, and other Bacterial colonization or infection of the intestine by patho- possible probiotics. However, depending upon the training gens such as Clostridium, Escherichia, Klebsiella, Salmonella, center, physicians may not be exposed to programs that discuss Shigella, Campylobacter, Pseudomonas, Streptococcus, Entero- and evaluate the advantages and disadvantages of so-called coccus, Staphylococcus aureus, and coagulase-negative staphy- nontraditional, complementary or alternative medicine, within lococci increases the risk of necrotizing enterocolitis. If non- which probiotics is sometimes placed. Governmental agencies pathogens, such as lactobacilli and bifidobacteria, colonize the such as the Food and Drug Administration are designed to intestine, or if breast milk rather than formula is used, the separate and regulate drugs from other substances, which in- incidence of necrotizing enterocolitis has been reported to fall advertently makes it very difficult for small health companies to (73). At the time of this finding in 1990, the authors estimated have the resources to seek claims and drug approval status for that in British neonatal units, exclusive formula feeding could probiotics. Meanwhile, physicians rightly require that the med- account for approximately 500 extra cases of necrotizing en- icines they prescribe or recommend have been tested, shown to terocolitis and 100 deaths each year. No recent comparison is have clinical effects, and be produced in reliable, reproducible available, but changes in infant formulas have been made over product formulations.
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