Mary Ellen Sanders

Dairy & Food Culture Technologies

Microbiomes provide key contributions to health and potentially important therapeutic targets. Conceived nearly 30 years ago, the prebiotic concept posits that targeted modulation of host microbial communities through the provision of selectively utilized growth substrates provides an effective approach to improving health. Although the basic tenet...

Probiotics are typically marketed as foods and dietary supplements, categories for products intended to maintain health in generally healthy populations and which, unlike drugs, cannot claim to treat or cure disease. This review addresses the existing evidence that probiotics are beneficial to healthy people. Our approach was to perform a descripti...

The term postbiotic was defined by the International Scientific Association of Probiotics and Prebiotics (ISAPP) as “a preparation of inanimate microorganisms and/or their components that confers a health benefit on the host.” Although the ISAPP definition is widely cited, some concerns were aired after publication, and alternative definitions of p...

Importance Systematic reviews and meta-analyses often report conflicting results when assessing evidence for probiotic efficacy, partially because of the lack of understanding of the unique features of probiotic trials. As a consequence, clinical decisions on the use of probiotics have been confusing. Objective To provide recommendations to improv...

Fermented foods are often erroneously equated with probiotics. Although they might act as delivery vehicles for probiotics, or other ‘biotic’ substances, including prebiotics, synbiotics, and postbiotics, stringent criteria must be met for a fermented food to be considered a ‘biotic’. Those criteria include documented health benefit, sufficient pro...

Plain Language Summary What is the context? Probiotics, available to healthy consumers as both dietary supplements and foods, are also used by some patient populations. The goal of this paper is to determine if any new factors have emerged that would impact current views about probiotic safety for both these populations. What is new? The authors co...

Background: Live dietary microbes have been hypothesized contribute to human health but direct evidence is lacking. Objectives: To determine if dietary consumption of live microbes is linked to improved health outcomes. Methods: Data from the National Health and Nutrition Examination Survey (NHANES) 2001-2018 were used to assess microbial inta...

The term postbiotic was recently defined by an panel of scientists convened by the International Scientific Association of Probiotics and Prebiotics as “a preparation of inanimate microorganisms and/or their components that confers a health benefit on the host.” This definition focused on the progenitor microbial cell or cell fragments, not just me...

A history of safe use is a backbone of safety assessments for many current probiotic species, however, there is no global harmonization regarding requirements for establishing probiotic safety for use in foods and supplements. As probiotic manufacturers are increasingly seeking to use new strains, novel species, and next-generation probiotics, just...

Background: Consuming live microbes in foods may benefit human health. Live microbe estimates have not previously been associated with individual foods in dietary databases. Objectives: We aimed to estimate intake of live microbes in US children (aged 2-18 y) and adults (≥19 y) (n = 74,466; 51.2% female). Methods: Using cross-sectional data fr...

The scientific community has proposed terms such as non-viable probiotics, paraprobiotics, ghostbiotics, heat-inactivated probiotics or, most commonly, postbiotics, to refer to inanimate microorganisms and/or their components that confer health benefits. This article addresses the various characteristics of different definitions of ‘postbiotics’ th...

p>In the original Supplementary Table associated with this Correspondence, the terms “postbiotic” and “ISAPP” were misspelled in the column heading and footnote, respectively. These errors have now been corrected and the Supplementary information updated online; for transparency, the updated Supplementary Table is available in the online version of...

The administration of broad-spectrum antibiotics is often associated with antibiotic-associated diarrhea (AAD), and impacts gastrointestinal tract homeostasis, as evidenced by the following: (a) an overall reduction in both the numbers and diversity of the gut microbiota, and (b) decreased short-chain fatty acid (SCFA) production. Evidence in human...

p>In the original version of this Consensus Statement article published online, a bar in Figure 1 was incorrectly labelled as “parabiotics” when it should have been labelled as “paraprobiotics”. This error has now been corrected in the HTML and PDF version of the article. Figure 1 | Total number of mentions in the literature of different terms refe...

In 2019, the International Scientific Association for Probiotics and Prebiotics (ISAPP) convened a panel of experts specializing in nutrition, microbial physiology, gastroenterology, paediatrics, food science and microbiology to review the definition and scope of postbiotics. The term ‘postbiotics’ is increasingly found in the scientific literature...

Background There is substantial demand for gut health products incorporating probiotics and prebiotics. They are being delivered as ingredients in an increasing range of different product formulations. While new delivery matrices are assessed for their potential impact on cell viability and prebiotic degradation, it is unknown whether they should b...

An expert panel was convened in September 2019 by The International Scientific Association for Probiotics and Prebiotics (ISAPP) to develop a definition for fermented foods and to describe their role in the human diet. Although these foods have been consumed for thousands of years, they are receiving increased attention among biologists, nutritioni...

The collective findings from human microbiome research, randomized controlled trials on specific microbes (i.e., probiotics), and associative studies of fermented dairy consumption provide evidence for the beneficial effects of the regular consumption of safe live microbes. To test the hypothesis that the inclusion of safe, live microbes in the die...

In May 2019, the International Scientific Association for Probiotics and Prebiotics (ISAPP) convened a panel of nutritionists, physiologists and microbiologists to review the definition and scope of synbiotics. The panel updated the definition of a synbiotic to “a mixture comprising live microorganisms and substrate(s) selectively utilized by host...

Still relevant after 19 years, the FAO/WHO definition of probiotics can be translated into four simple and pragmatic criteria allowing one to conclude if specific strains of microorganisms qualify as a probiotic for use in foods and dietary supplements. Probiotic strains must be (i) sufficiently characterized; (ii) safe for the intended use; (iii)...

While probiotics have not been marketed as drugs, clinicians can still recommend them in an evidence-based manner.

[This corrects the article DOI: 10.3389/fphar.2019.00980.].

Acute respiratory tract infections (RTIs) of viral origin place a substantial burden on health care resources and society. Randomized controlled trials have shown positive effects of probiotics on clinical outcomes in these commonly occurring RTIs. Two meta-analyses published by the York Health Economics Consortium (YHEC) and Cochrane reported the...

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Probiotics and prebiotics are microbiota-management tools for improving host health. They target gastrointestinal effects via the gut, although direct application to other sites such as the oral cavity, vaginal tract and skin is being explored. Here, we describe gut-derived effects in humans. In the past decade, research on the gut microbiome has r...

Probiotics, live microorganisms that, when administered in adequate amounts, confer a health benefit on the host, and prebiotics, substrates that are selectively utilized by host microorganisms conferring a health benefit, make up a group of highly researched substances targeted at influencing microbiota‐mediated functions for the benefit of the ho...

To the Editor The Viewpoint by Cohen¹ that was recently published in JAMA Internal Medicine dismisses a diligent approach to probiotic safety assessment undertaken by regulatory authorities, as well as the long history of safe use of probiotics in foods.

Background: Overall reduction of antibiotic use is a widely adopted public health goal. Given evidence that consuming probiotics reduce the incidence, duration and/or severity of certain types of common acute infections, we hypothesized that probiotics are associated with reduced antibiotic use. This systematic review of randomized controlled tria...

Strain-specificity of probiotic effects has been a cornerstone principle of probiotic science for decades. Certainly, some important mechanisms are present in only a few probiotic strains. But scientific advances now reveal commonalities among members of certain taxonomic groups of probiotic microbes. Some clinical benefits likely derive from these...

In December 2016, a panel of experts in microbiology, nutrition and clinical research was convened by the International Scientific Association for Probiotics and Prebiotics to review the definition and scope of prebiotics. Consistent with the original embodiment of prebiotics, but aware of the latest scientific and clinical developments, the panel...

Objective: To inform health care providers about quality standards for manufacture of probiotic products being recommended for at-risk patient populations. Summary: Probiotics are used in a variety of clinical settings, sometimes in at-risk populations for therapeutic endpoints. Although probiotics might not be approved as drugs, they are someti...

Objectives: Probiotics are live microorganisms that may provide health benefits to the individual when consumed in sufficient quantities. For studies conducted on health or disease endpoints on probiotics in the United States, the Food and Administration has required those studies to be conducted as investigational new drugs. This phase I, double-...

This is a summary from a workshop convened as part of the 13(th) annual meeting of the International Scientific Association for Probiotics and Prebiotics. A group of 24 stakeholders, including clinical experts, researchers, federal government officials, funding agencies, lawyers and industry experts met to review the challenges of the current regul...

Probiotic research has progressed greatly in recent years, to the extent that full genomic sequencing is becoming commonplace for strains used in intervention trials. Unfortunately, examples of inaccurate nomenclature or incomplete taxonomic description of probiotic strains still occurs in the scientific database. One recent example is a publicati...

This paper addresses the use of systematic review and meta-analysis to evaluate the strength of evidence for health benefits of probiotic foods, especially relating to health claim substantiation in the European Union. A systematic review is a protocol-driven, transparent and replicable approach, widely accepted in a number of scientific fields, an...

This paper describes the consensus opinion of the participants in the 4th Triennial Yale/Harvard Workshop on Probiotic Recommendations. The recommendations update those of the first 3 meetings that were published in 2006, 2008, and 2011. Recommendations for the use of probiotics in necrotizing enterocolitis, childhood diarrhea, inflammatory bowel d...

The field of probiotics continues to evolve and progress. This paper reviews several situations within the probiotic field that are of current interest, including review of the scope of the proper use of the term “probiotic,” use of systematic reviews and meta-analyses for probiotics, regulatory challenges to doing human research on probiotics in t...

This paper describes the consensus opinion of the participants in the 4th Triennial Yale/Harvard Workshop on Probiotic Recommendations. The recommendations update those of the first 3 meetings that were published in 2006, 2008, and 2011. Recommendations for the use of probiotics in necrotizing enterocolitis, childhood diarrhea, inflammatory bowel d...

Abstract Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to determine the safety of Bifidobacterium a...

Fermented foods have been consumed for centuries across many geographical locales and have traditionally been considered healthy foods, partly because of the live microbes contained in them. The concept of "probiotics" further requires that the microbes be defined and their health effects be demonstrated through human intervention studies or other...

An expert panel was convened in October 2013 by the International Scientific Association for Probiotics and Prebiotics (ISAPP) to discuss the field of probiotics. It is now 13 years since the definition of probiotics and 12 years after guidelines were published for regulators, scientists and industry by the Food and Agriculture Organization of the...

Recent systematic reviews have reported a positive, although modest, effect of probiotics in terms of preventing common cold symptoms. In this systematic review, the effect of probiotics, specifically Lactobacillus and Bifidobacterium strains, on the duration of acute respiratory infections in otherwise healthy children and adults was evaluated. To...

Commercial probiotic strains for food or supplement use can be altered in different ways for a variety of purposes. Production conditions for the strain or final product may be changed to address probiotic yield, functionality, or stability. Final food products may be modified to improve flavor and other sensory properties, provide new product form...

Probiotics and prebiotics are useful interventions for improving human health through direct or indirect effects on the colonizing microbiota. However, translation of these research findings into nutritional recommendations and public health policy endorsements has not been achieved in a manner consistent with the strength of the evidence. More pro...

Beneficial microbes enter the food supply primarily through fermented foods (largely milks) and addition of probiotics. Fermented milks are a significant component of the diet of some geographical regions, including Europe. The fermentation process serves to preserve safety, nutritional quality and palatability of milk. In addition, the microbes as...

Recent advances in our understanding of the community structure and function of the human microbiome have implications for the potential role of probiotics and prebiotics in promoting human health. A group of experts recently met to review the latest advances in microbiota/microbiome research and discuss the implications for development of probioti...

Probiotics are derived from traditional fermented foods, from beneficial commensals or from the environment. They act through diverse mechanisms affecting the composition or function of the commensal microbiota and by altering host epithelial and immunological responses. Certain probiotic interventions have shown promise in selected clinical condit...

Indigenous microbiota are an essential component in the modern concept of human health, but the composition and functional characteristics of a healthy microbiome remain to be precisely defined. Patterns of microbial colonization associated with disease states have been documented, but the health-associated microbial patterns and their functional c...

In Table 2 (page 1041), the source for 2 bacterial strains was incorrect. Strains with laboratory designations DPTC 047 (B. infantis BBI) and DPTC 003 (B. longum BBL) were incorrectly noted to come from Chr. Hansen (Milwaukee, WI); these strains were actually from Danisco (Madison, WI). The authors regret the error.

Although precise mechanisms responsible for all demonstrations of probiotic health benefits are not known, many lines of evidence suggest that probiotics function through direct or indirect impact on colonizing microbiota of the gut. Probiotics can directly influence colonizing microbes through multiple mechanisms, including the production of inhib...

This study describes the consensus opinion of the participants of the third Yale Workshop on probiotic use. There were 10 experts participating. The recommendations update those of the first 2 meetings that were published in 2005 and 2008. The workshop presentations and papers in this supplement relate to the involvement of normal microbiota involv...

Probiotics are live microorganisms that confer a health benefit on the host when administered in appropriate amounts. Over 700 randomized, controlled, human studies have been conducted with probiotics thus far, with the results providing strong support for the use of probiotics in the clinical prevention or treatment of gastrointestinal tract disor...

The topic of "Health Claims Substantiation for Probiotic and Prebiotic Products" was discussed at the 8 (th) annual International Scientific Association for Probiotics and Prebiotics (ISAPP) meeting. The topic is especially timely considering that the regulatory review process for health benefit claims on probiotic and prebiotic products in Europe...

To determine if consumption of yogurt containing a high dose of probiotic (1×10(10) colony-forming unit per 100 ml), Bifidobacterium animalis subsp. lactis (B. lactis), decreases absences in children 2-4 years attending daycare/school centers. We conducted a double-blinded, randomized, placebo-controlled, allocation concealment clinical trial in th...

Presented by the New York Academy of Sciences, the U.S. Food and Drug Administration (FDA), and the U.S. Office of Dietary Supplements of the National Institutes of Health, the symposium "Probiotic Foods and Supplements: The Science and Regulations of Labeling," was held on June 12, 2010 at the New York Academy of Sciences, New York, NY, the goals...

IntroductionHealth benefit claims allowable in the United StatesSubstantiation of health benefit claims for probioticsBridging the gap between the US consumer, probiotic science and commercial productsConclusions

Background and aims: Functional foods, especially yogurt, are attractive delivery agents for probiotics due to their popularity with parents and children; however, few commercially available products have strong clinical-based evidence. Our primary objective was to determine if consumption of a probiotic-supplemented yogurt-based beverage containin...

"Probiotics: From Bench to Market" was a one-day conference convened by the New York Academy of Sciences on June 11, 2010, with the goal of stimulating discussion of the physiological effects of probiotics on the gastrointestinal, nervous, and immune systems. The program included speakers from academia, industry, and government to give conference p...

To evaluate whether a fermented dairy drink containing the probiotic strain Lactobacillus casei DN-114 001 could reduce the incidence of common infectious diseases (CIDs) and the change of behavior because of illness in children. We conducted a double-blinded, randomized, placebo-controlled allocation concealment clinical trial in the Washington, D...

The heterogeneity of human clinical trials to assess the effectiveness of probiotics presents challenges regarding interpretation and comparison. Evidence obtained from clinical trials among a population with a disease or specific risk factors may not be generalizable to healthy individuals. The evaluation of interventions in healthy persons requir...

The safety of probiotics is tied to their intended use, which includes consideration of potential vulnerability of the consumer or patient, dose and duration of consumption, and both the manner and frequency of administration. Unique to probiotics is that they are alive when administered, and unlike other food or drug ingredients, possess the poten...

Probiotic bacteria are increasingly incorporated into food products intended to confer health benefits in the human gut and beyond. Little is known about how the food matrix and product formulation impacts probiotic functionality, even though such information is essential to scientific understanding and regulatory substantiation of health benefits....

Probiotic functional foods are widely advertised to consumers primarily based on probiotic supplements. Determine if consumption of yogurt containing a high dose of probiotics improves health in children ages 1-3 years attending daycare/school centers. Double-blinded, randomized, placebo-controlled, allocation concealment clinical trial. Outpatient...

A novel combination of culturing and DNA-based terminal restriction fragment length polymorphism (TRFLP) analysis was used to investigate the effect of probiotics on antibiotic-induced gut microbiota alterations to determine if a probiotic preparation containing bifidobacteria and lactobacilli, taken during and after antibiotic therapy, can minimiz...