Minimum criteria for probiotics: ISAPP perspectives

By Mary Ellen Sanders PhD, Executive Science Officer, ISAPP

During its 2018 annual meeting (June 5-7), ISAPP convened a group of 30 participants from 13 countries to address issues associated with global harmonization of regulations for probiotics and prebiotics. This topic was of interest due to the broad international presence at this meeting, ISAPP’s first in Asia. The goal of this group was to provide regulators guidance derived from this assemblage of experts regarding the minimum criteria a probiotic food or supplement should meet. Drs. Seppo Salminen, Yuan-Kun Lee, and Gabriel Vinderola, who chaired this group, recently completed a summary titled “ISAPP position statement on minimum criteria for harmonizing global regulatory approaches for probiotics in foods and supplements”.

In December of 2017 the International Probiotic Association (IPA) presented a proposal to Codex Alimentarius – a recognized body that develops global standards and guidelines related to foods – regarding establishment of guidelines for probiotic foods. Codex Alimentarius accepted this proposal and requested that Argentina prepare draft guidelines to be considered in the 2018 session of the Codex Alimentarius  Committee on Nutrition and Foods for Special Dietary Use. ISAPP representatives and group coordinators (Sanders, Salminen and Vinderola) took part along with IPA in a scientific meeting in Argentina to present the ISAPP views to local authorities and experts.  IPA hopes that these efforts will lead to harmonized regulations since “this lack of harmonization in industry practice and legislation remains and often leads to serious issues and concerns for the probiotics industry, regulators, and even consumers in regard of quality, safety and labelling.” (Page1 of the proposal)

As the efforts of harmonization of regulations for probiotic foods through Codex progresses, ISAPP offers – through this summary document – its perspectives on minimum criteria for probiotics. The ISAPP group’s conclusions echo the principles outlined in the IPA proposal. Our hope is that this ISAPP document will provide useful perspective to local regulators. As of this writing, Prof. Salminen has delivered this document to the Codex representative at the Finnish Ministry of Agriculture and Food. We hope that further dissemination of the perspectives in this document will contribute to a science-based approach to global harmonization of regulations for probiotics.

See the document for the list of minimum criteria.

ISAPP Releases New Infographic – Probiotic Checklist: Making a Smart Selection

Not all products labelled “probiotic” are true probiotics. ISAPP just released a new infographic focused on helping consumers make smart selections when examining probiotic products. The infographic addresses identifying products backed by science, effective dosing, and more.

See and download the full infographic here.

See all ISAPP infographics here.

 

ISAPP-initiated systematic review and meta-analysis shows the association of probiotic consumption with reduced antibiotic prescriptions

At the ISAPP meeting in Turku, Finland in 2016, scientists convened a working group led by Dan Merenstein of Georgetown University (USA) along with Irene Lenoir-Wijnkoop of University of Utrecht (the Netherlands) and Danone Research. In their discussions, the group identified a gap in the literature: a systematic review of randomized, controlled trials to determine how antibiotic prescriptions are associated with probiotic consumption for the prevention of common acute infections. The protocol was registered with PROSPERO (registration number CRD42016052694).

The analysis, authored by ten scientists, was recently published—and results showed that infants and children who received probiotics were at least 29% less likely to be prescribed antibiotics. Find the paper here in the European Journal of Public Health.

ISAPP scientists say probiotics deserve consideration as a public health intervention that may reduce the widespread over-prescription of antibiotics.

See the ISAPP press release here, and the Georgetown University press release here.

See here for media coverage of this paper:

http://www.microbiometimes.com/scientific-analysis-shows-probiotic-use-is-associated-with-fewer-antibiotic-/

https://www.pharmacytimes.com/resource-centers/vitamins-supplements/daily-probiotics-may-reduce-kids-need-for-antibiotics

https://www.news-medical.net/news/20180914/Probiotics-could-reduce-the-need-for-antibiotics.aspx

Clinical evidence and not microbiota outcomes drive value of probiotics

By ISAPP Board of Directors, plus Prof. Francisco Guarner and Dr. Bruno Pot

September 10, 2018

Two recent papers have generated much adverse publicity for the probiotic field. Headlines driven by sensationalism, not data, claim “Probiotics labelled ‘quite useless’” (BBC) and “Probiotics ‘not as beneficial for gut health as previously thought’” (The Guardian). The quotes are from author Eran Elinav, who generalizes the study findings to all ‘probiotics’ as a class – a generalization that ignores that specific probiotic are meant for specific purposes. This research was published this month in Cell (here and here).

The scope of these papers is limited to microbiome data; no clinical endpoints are assessed. Without clinical evidence, it is not possible to conclude about the tested probiotic’s usefulness, and it is certainly not possible to conclude about probiotic usefulness in general. Stating that probiotics are ‘quite useless’ or ‘not as beneficial’ is, quite simply, wild and factually inaccurate. The authors discount the existing body of evidence for probiotic health benefits, including Level 1 placebo-controlled, randomized trials. Cochrane reviews (the gold standard used by physicians and public health policy makers) of the totality of evidence show that specific probiotics can prevent antibiotic associated diarrhea (AAD) and C. difficile diarrhea. This evidence has been translated into evidence-based recommendations for probiotics issued by medical groups. Regardless of an effect on the microbiota, these are established, evidence-based benefits of probiotics.

No clinical endpoints tracked in either study

What these papers provide is extensive data about the impact of one product containing 11 common probiotic species on different microbiome measures. To the authors’ credit, they analyzed mucosal and luminal samples from humans, in addition to samples from stool.  Nonetheless, the probiotic definition [live microorganisms that, when administered in adequate amounts, confers a health benefit on the host (Hill et al 2014)] does not require that probiotics function via interaction with the microbiota, nor is there much evidence that they alter the microbiota composition in an appreciable manner. Absence of impact on microbiome measures is not evidence that probiotics lack clinical or physiological effects. Probiotics function via many mechanisms that might not be revealed by the measures made in these papers.

Methodological concerns

A careful reading of this paper reveals many methodological concerns.

The extensive data in the paper is an assortment of different types of analyses. For example, for a beta-diversity metric, they sometimes use weighted Unifrac, sometimes unweighted Unifrac, and sometimes Bray-Curtis, without an explanation for their choice. These approaches to presenting the data can give very different results. With the transcriptomics data, sometimes the authors choose samples from the duodenum and sometimes the jejunum. For example, in figure 6, panels C-E compare the difference in gene expression between the naïve group and the treatment in the duodenum, whereas in panels F-H they compare the antibiotic state with the treatment in the jejunum. Such an approach leads the reader to speculate that the authors picked the metrics and data that best fitted the story they wanted to tell. In a well-conducted clinical trial, the statistical plan is registered before the study starts, to assure readers that the scientific process of advancing a hypothesis and designing a study to test the hypothesis is respected.

The probiotic was not administered to human subjects until 7 days after the treatment with antibiotics commenced, after the damage by the antibiotics has been done. Dozens of human studies with specific probiotics have documented that probiotics prevent AAD or C. difficile infection. In most clinical trials, the probiotic is administered together with the antibiotics. A recent meta-analysis concluded that “administration of probiotics closer to the first dose of antibiotic reduces the risk of (Clostridium difficile infection) by >50% in hospitalized adults.” (Emphasis added) The approach in the Suez et al paper is not consistent with the aforementioned clinical studies, with how probiotics are used in clinical practice or with the knowledge of how probiotics most likely prevent AAD. When provided on the same days as antibiotics, probiotics have the opportunity to prevent overgrowth of opportunistic, antibiotic-resistant microbes by competitive exclusion in the ecosystem. Therefore, the microbiome findings of Suez et al likely cannot be applied to clinical trials with such different time course of antibiotic/probiotic administration.

Several conclusions about the effect of probiotics on the microbiota were based on relative abundance measures, which do not relate to actual bacterial numbers or metabolic activity of all relevant species in the gut.

The antibiotic treatment used was potent for a study population that would otherwise not need antibiotics. Volunteers were administered oral ciprofloxacin 500 mg bi-daily and oral metronidazole 500 mg tri-daily for a period of 7 days. They are both very strong and indiscriminate antibiotics, having a severe impact on the gut microbiota.  One could question if this drug therapy might have a different impact on the microbiome of a healthy person compared to a patient likely to receive this treatment, i.e., one whose microbiota ecosystem is disrupted by disease or fever.

The probiotic product

A serious issue is that the authors chose a product for this study that has no demonstrated clinical benefits. At a minimum, the product used for this study should have evidence for impact on antibiotic associated conditions, including symptoms or emergence of opportunistic pathogens. The 3 (possibly 2, as the latter 2 appear to be the publication of the same data) human studies conducted on this product (here, here and here), showed no clinical benefit. Thus, the investigators tested the potential benefits of a product for which no benefits had been previously shown. Further, the papers do not adequately describe the product; only a total count (25 billion) is given; counts of each strain – through the end of the administration period – should have been provided. Furthermore, the authors state about the product that “B. longum was probably represented by two strains.” This constitutes imprecise characterization unacceptable in a well-defined probiotic product.

Appearance of author bias

The conclusions reached in the papers promote a personalized approach to probiotic use. In an article on the BBC, the lead author stated, “In the future probiotics will need to be tailored to the needs of individual patients. And in that sense just buying probiotics at the supermarket without any tailoring, without any adjustment to the host, at least in part of the population, is quite useless.” The authors did not disclose they are involved with a company promoting this personalized approach.

Probiotic colonization

The authors suggest that their finding that probiotics do not colonize long term is noteworthy. In fact, researchers in this field have known this for 30 years: most probiotics do not colonize or become established as part of the resident microbiota. A 2016 paper by Madonado-Gomez et al was notable precisely because a Bifidobacterium longum strain was found that did persist. In most cases, probiotic effects are likely mediated by transient effects.

Responders and non-responders

A well-established concept in medicine is that some people respond clinically and physiologically to interventions and others don’t. This is the case with much of probiotic as well as pharmaceutical literature. (See review on responders and non-responders to probiotics by Reid et al.) An individual’s response is likely impacted by diet, resident microbes, host genes and host physiology/health. The validity of a personalized approach to probiotic administration remains to be determined, as evidence for a clinical benefit to the approach is needed. Microbiome data alone are not sufficient.

Need for future research

In the Cell publications, the authors acknowledge their study was limited due to lack of clinical endpoints and the testing of only a single product. It is unfortunate that the press marched ahead with inflammatory stories about the negative effects of probiotics based on such paltry evidence. The scientific community understands that this is one study, on a small number of human subjects, by one research group. Sweeping conclusions cannot be made. There are many hypotheses that can be generated from this study that can lead to follow up studies, which we hope will ensue.

Conclusions

Hundreds of human trials have demonstrated clinical benefits of probiotics and several evidence-based recommendations have been issued by medical organizations. Of course, not all studies are positive. Not all probiotics work for all conditions. But the safety record of probiotics administered to healthy as well as many patient populations is well-established. Numerous media outlets have reported on these two studies as if they are proof that probiotics are useless at best and harmful at worst. This irresponsible reporting may lead people who are benefitting from probiotics to stop using them, potentially causing real harm.

The erroneous interpretation of the current study and previous research by the primary author is disingenuous, as he states,  “Contrary to the current dogma that probiotics are harmless and benefit everyone, these results reveal a new potential adverse side effect of probiotic use with antibiotics that might even bring long-term consequences.” This comment and the papers’ conclusions are not corroborated by the totality of safety and efficacy clinical evidence on probiotics, which includes thousands of probiotic-treated subjects. In comparison, the data in Suez et al come from microbiome assessments from only eight probiotic-treated subjects.

Furthermore, this paper evaluated just one product of limited provenance and containing a combination of multiple, incompletely characterized strains. This is in sharp contrast to numerous studies of precisely characterized strains demonstrating well-defined and beneficial engagements with the host. Zmora and colleagues and Suez and colleagues are to be congratulated on their attempts to characterize in detail the impact of one probiotic product on a perturbed, human microbiome. We look forward to further such studies employing well-characterized strains with demonstrated clinical benefits and including relevant clinical endpoints.

Additional reading:

ISAPP comments: International Group of Probiotic Scientists Weighs in on Flawed Conclusions From New Scientific Papers

American Gastroenterological Association response: AGA’s Interpretation of the Latest Probiotics Research

Response by Prof. Gregor Reid:  Trying to Close the Stable Door After the Horse Has Bolted

‘Brain fogginess’ and D-lactic acidosis: probiotics are not the cause

Mary Ellen Sanders PhD, Executive Science Officer, International Scientific Association for Probiotics and Prebiotics

Bruno Pot PhD, Research Group of Industrial Microbiology and Food Biotechnology, Faculty of Sciences and Bioengineering Sciences, Vrije Universiteit Brussel, Pleinlaan 2, B-1050 Brussels, Belgium

See here for ISAPP letter to the Clinical and Translational Gastroenterology editor regarding this paper.

See related post Probiotics and D-Lactic Acid Acidosis in Children

Rao and colleagues incriminated probiotics in the induction of D-lactic acidosis in their paper titled “Brain fogginess, gas and bloating: a link between small intestinal bacterial overgrowth (SIBO), probiotics and metabolic acidosis” (Rao et al. 2018). Eamonn Quigley MD, Bruno Pot, microbiologist and I on behalf of ISAPP authored a letter to the editor of Clinical and Translational Gastroenterology (currently In Press), summarizing many medical and other concerns with the study design, execution and conclusions.

It is regrettable that one poorly controlled paper can lead to such negative backlash on the probiotic field. Respectable media outlets including Newsweek, Science Daily, Psychology Today, the Daily Mail, MSN.com, and others blindly reported the results of this study without critical analysis of the paper. These stories advance the opinion that probiotics are potentially harmful and should be sold only as drugs. This flies in the face of many scientific studies that document safety compounded with safe, worldwide consumption for decades of probiotic foods and supplements.

Bifidobacterium as a genus does not yield D-lactate as a metabolic end product. Some Lactobacillus species do (Table 19.1 in Pot 2014). Among common probiotic Lactobacillus species, the following are classified as species that can produce D-lactic acid: L. acidophilus, L. gasseri, L. delbrueckii subsp. bulgaricus (one of the 2 yogurt starter culture bacteria), L. fermentum, L. lactis, L. brevis, L. helveticus, L. plantarum and L. reuteri.  Individual strains within each species may vary with regard to levels of D-lactic acid produced.

The observational nature of the Rao et al. paper precludes any conclusive link between probiotic consumption and symptoms observed.  The authors acknowledge that they have only established an association between probiotic use and the symptoms, but the misleading paper title suggests an intention to indict probiotics, even in the absence of evidence.  It is much more likely that the patient population with underlying SIBO in this study sought relief from their gut symptoms by use of probiotics rather than the probiotics being the cause of their symptoms.

D-lactic acidosis is a rare but serious condition, typically occurring in people with short bowel syndrome. These patients should know that D-lactate-producing probiotics are not recommended for them. In people with a normal gut, D-lactate produced by members of the gut microbiota – including some probiotics – is metabolized by other members of the gut microbiota and does not accumulate. Thus, under normal circumstances, D-lactic acidosis does not result from consumption of D-lactic acid-producing probiotics. The patients in the Rao et al. study showed very low levels of D-lactic acid, calling into question if these SIBO patients were even acidotic.  Moreover, the D-lactic acid that was present was not proven to be a result of probiotic growth. This is important, as intestinal bacteria including Escherichia coli also produce D-lactic acid. In cases of SIBO, numerous metabolites are produced in the small intestine (including alcohol), leading to a variety of SIBO symptoms, possibly including the poorly defined phenomenon of “brain fogginess”.  Many issues that should have been were not addressed in the Rao et al. paper.

The real tragedy with the publication of this paper is that – similar to many such media scares in the past – it is may cause harm.  The sensationalist headlines may dissuade safe probiotic use in people who can truly benefit from them. Scientists and clinical researchers – both academic and from industry – must remain diligent in assessment and reporting of any probiotic harms. However, the Rao et al. paper is not an example of this.

Reference:

Pot B. 2014. The genus Lactobacillus. Chapter 19. In Lactic Acid Bacteria: Biodiversity and Taxonomy, First Edition. Edited by Wilhelm H. Holzapfel and Brian J.B. Wood. 2014 John Wiley & Sons, Ltd.

Other reading:

Mack D. 2004. D(-)-lactic acid producing probiotics, d(-)-lactic acidosis and infants. Canadian J Gastroenterol. 18:671-5. (ISAPP-commissioned paper)

Łukasik J, Salminen S, Szajewska H. Rapid review shows that probiotics and fermented infant formulas do not cause d-lactic acidosis in  healthy childrenActa Paediatr. 2018 Aug;107(8):1322-1326. doi: 10.1111/apa.14338. Epub 2018 Apr 24.

cber

CBER to hold public workshop on regulation of biologics

FDA’s Center for Biologics Evaluation and Research (CBER) is convening a public workshop Sept 17 in Rockville MD on the Science & Regulation of Live Microbiome-Based Products Used to Prevent, Treat, or Cure Diseases in Humans. It is now open for registration (free). See here for the program and here for additional info.

The evidence for efficacy, the safety and the regulatory framework for probiotics other live microbiome based products will be discussed. Prof. Dan Merenstein MD, ISAPP’s current Vice President, will speak on evidence, research and clinical use of probiotics for antibiotic associated diarrhea. Although the title suggests the meeting will focus on drugs, Dr. Bob Durkin from the Center for Food Safety and Applied Nutrition (CFSAN) of the FDA will speak on probiotic foods and dietary supplements.

This workshop is an opportunity for stakeholders to share with FDA and NIH concerns regarding the regulatory approach to probiotics adopted by the FDA. The path for development of probiotic drugs is reasonably clear. But the road to develop probiotic foods, supplements or microbiome-based dietary strategies to compensate for deficient microbiota is less so. These products are intended to improve gut function, nutritional status, immune status, metabolic properties and more. These are legal functions for foods and supplements, but the FDA doesn’t seem to see it that way.

The FDA has for the most part has approached probiotics as drugs (Sanders et al. 2016). Since probiotics are live microbes, and since CBER deals with drugs that are derived from living sources, CBER often oversees human research on probiotics. But there is no mechanism within CBER to oversee foods and supplements, and hence, human research on probiotics tends to be shunted into the investigational new drug (IND) process. But, the legal definitions of drugs and foods overlap – both can impact the structure/function of the human body and both can reduce the risk of disease. So conducting such research on probiotic foods – and not as part of the IND rubric – should be possible. Perhaps progress on this front can be achieved in the CBER workshop in September.

In a press announcement, FDA Commissioner Scott Gottlieb MD shared FDA perspective on probiotics and promoted this CBER conference. A couple of issues are noteworthy in this announcement by Gottlieb. First, the term ‘probiotic’ is used. Over the years, the FDA largely avoided use of this term, instead favoring the term live biotherapeutic product (LBP). But these terms are not synonymous. Probiotic is defined as a live microorganisms that, when administered in adequate amounts, confers a health benefit on the host (Hill et al. 2014). It spans multiple regulatory categories. A LBP is by definition a drug. The fact that Gottlieb used the term ‘probiotic’ may signal that he recognizes that not all probiotics are drugs. Second, Gottlieb’s announcement shows awareness that probiotics are legitimate components in foods and dietary supplements and states that the FDA is “committed to working with industry on efforts to provide information that can help consumers make more informed choices about these products.” This is a welcome statement to many researchers involved in probiotic foods and supplements in the United States. It suggests that the FDA is willing to look beyond probiotics as LBPs and develop regulatory approaches for research and claims appropriate to foods and supplements.

Innovation in this field, which has the potential to benefit many people globally, requires regulatory approaches that do not obstruct. Participation in this workshop may lead to improvements that both protect public safety and facilitate academic and industry researchers in the United States on the path to discovery.

 

Additional information:

Sanders ME, Shane AL, Merenstein DJ. Advancing Probiotic Research in Humans the United States: Challenges and strategies. Gut Microbes 7(2):97-100.

Warning letter from CBER: Dietary Supplements Containing Live Bacteria or Yeast in Immunocompromised Persons: Warning – Risk of Invasive Fungal Disease. Posted 12/09/2014.

ISAPP publishes new paper on “Human Use of Probiotics”

ISAPP, working with the British publication Nutrition Bulletin, published an open access paper on “Human Use of Probiotics”.

The paper provides an overview of probiotics in the 21st Century, summarizes health conditions where actionable evidence on probiotic use exists, considers fermented food in the context of probiotics, and provides some regulatory and marketplace perspective.

“Most reviews covering health benefits of probiotics focus on specific conditions in depth. In this paper we try to include all benefits with compelling evidence,” Sanders says.

Access the paper here.

2018 Annual Meeting Report Now Available

The meeting report for the Annual Meeting June 5-7th 2018 ISAPP in Singapore is now available, featuring overviews of the speakers and discussion group conclusions.

Two days of plenary talks focused on the latest science featuring prebiotic and probiotic use in: pediatrics, oral health, allergy immunotherapy, the gut microbiome throughout life, synbiotics, liver disease, honey bee health, chronic gut disorders, and more. The meeting also featured an interesting talk about the changes coming in the nomenclature of the genus Lactobacillus.

The plenary, open sessions were followed by a Discussion Forum on June 7th for invited experts and Industry Advisory Committee Members. The discussion groups focused on:

  • Harmonizing Global Probiotic and Prebiotic Food/Supplement Regulation
  • Fermented Foods for Health: East Meets West
  • Potential Value of Probiotics and Prebiotics to Treat or Prevent Serious Medical Issues in Developing Countries
  • Prebiotics as Ingredients: How Foods, Fibres and Delivery Methods Influence Functionality

Finally, there were over 70 posters presented at the meeting featuring the latest prebiotic and probiotic research from around the world.

Slides and abstracts for the meeting can be found on the ISAPP website under the “Annual Meetings” tab, available to meeting participants only.

definition

ISAPP conducts webinar on definitions in microbiome space for ILSI-North America Gut Microbiome Committee

Dr. Mary Ellen Sanders presented a webinar July 23, 2018 – covering basic definitions of microbiota-mediated terminology – to the ILSI-North America Gut Microbiome Committee, which you can listen to here. The objective was to update the committee about terms with clear and actionable consensus definitions in the microbiome space. ISAPP is committed to proper use of terms such as ‘probiotics’ and ‘prebiotics’, as evidenced by the consensus panels it has convened (see here and here) on these topics. Definitions of some newly emerging terms such as postbiotic, abiotic, and probioceuticals are less clear.

Some issues covered in this webinar include comparison with historic definitions, minimum criteria for commercial probiotic and prebiotic products, contrasting probiotic food with fermented food, and a brief discussion of imminent taxonomy changes for the genus, Lactobacillus.

The webinar is now available here.

seppo

Welcome Seppo Salminen – ISAPP’s New President

An interview with Prof. Seppo Salminen

ISAPP President 2018-2021

 

1) What are your goals as the next president of ISAPP? 

My goal is to work together with the board and the members to advance excellence in the science of probiotics and prebiotics and to share research and conclusions with as wide an audience as possible. It is also my goal to leverage ISAPP’s scientific  expertise to work with organizations to promote  evidence-based applications of probiotics and prebiotics to advance health and well-being of people.

2) What do you hope to see the organization accomplish during your tenure?

ISAPP is engaged now in North America, Europe and Asia so maybe we can be really be global and reach out to South America and  connect with researchers in Africa as we have done with Professor Reid earlier. I would like to work toward common goals with more industrial, scientific and regulatory experts from different parts of the world.

3) What changes do you foresee in the field of probiotics and prebiotics in the next few years?

 I foresee rapid development in probiotics and prebiotics. There will be novel microorganisms developed and novel sources of prebiotics and this direction leads to challenges in safety evaluation and efficacy demonstration  as well as communication of the results to larger audiences.

4) How did you originally become involved in ISAPP?

I was originally invited to one ISAPP meeting, then to the next one, then to the third one and at the end was invited to be a member of the board, which I considered a special honour!

5) Which ISAPP meeting was your favorite so far?

They all have been excellent, but some I remember (each for different reasons) are the ones in Barcelona, New York, Chicago and Berkeley – and now Singapore. Of course, the one in Turku, Finland as well – when you help organize a meeting like that you certainly remember even on a minute-by-minute basis.

Thank you Prof. Salminen and welcome!

2018_Singpaore

ISAPP’s First Meeting in Asia is a Huge Success

June 5-7th 2018 ISAPP held it’s first Asian meeting in Singapore. This open registration meeting was a huge success with over 240 attendees from 34 countries.

Two days of plenary talks focused on the latest science featuring prebiotic and probiotic use in: pediatrics, oral health, allergy immunotherapy, the gut microbiome throughout life, synbiotics, liver disease, honey bee health, chronic gut disorders, and more. The meeting also featured an interesting talk about the changes coming in the nomenclature of the genus Lactobaccilus.

The plenary, open sessions were followed by a Discussion Forum on June 7th for invited experts and Industry Members. The discussion groups focused on:

  • Harmonizing Global Probiotic and Prebiotic Food/Supplement Regulation
  • Fermented Foods for Health: East Meets West
  • Potential Value of Probiotics and Prebiotics to Treat or Prevent Serious Medical Issues in Developing Countries
  • Prebiotics as Ingredients: How Foods, Fibres and Delivery Methods Influence Functionality

Finally, there were over 70 posters presented at the meeting featuring the latest prebiotic and probiotic research from around the world.

Next year, ISAPP will be hosting an invite-only meeting in Antwerp, Belgium – May 14-16, 2019. To attend this meeting, join ISAPP as an Industry Member.

      

karen_scott

ISAPP’s Outgoing President: Karen Scott

Dr. Karen Scott of the Rowett Institute of the University of Aberdeen has served as the ISAPP President for the last three years. During her time as President, ISAPP has seen some incredible growth and accomplishments, and the organization is so grateful for her leadership.

Last year, under Karen’s leadership, ISAPP produced a prebiotic consensus panel paper, which remains one of the highest cited papers in nature reviews gastroenterology and hepatology.

In addition, over the last three years the Science Translation Committee has produced nine infographics, four videos, monthly blog posts, and a monthly newsletter focused on disseminating clinical and consumer information on probiotics and prebiotics.

Karen led three successful ISAPP Annual Meetings – Turku in 2016, Chicago in 2017, and ISAPP’s first meeting in Asia which took place in Singapore in 2018. All of these meetings followed her acting as local host for the 2014 ISAPP meeting in Aberdeen.

ISAPP’s mission to educate resulted in numerous outreach activities over the last three years including continuing education opportunities, webinars, the USP expert panel on probiotics, and regulator engagements. In terms of advancing the science, under Karen’s leadership ISAPP has published 21 peer-reviewed articles on probiotics and prebiotics.

Finally, industry involvement in ISAPP has remained strong and steady during Karen’s term, with 40-45 industry members from around the world. These industry members support ISAPP’s activities and participate in the annual meeting each year to hear about the latest probiotic and prebiotic science available.

Thank you so much Karen for your dedication and hard work to advance scientific excellence in probiotics and prebiotics.

medscape_webinar

Medscape Webinar on Probiotics – Now Available!

“Navigating the world of probiotics: Helping  patients make good choices”

This 30-min CME activity, which took place on April 17th, by Medscape is now available online https://www.medscape.org/viewarticle/897109 The webinar features Prof. Dan Merenstein MD and Mary Ellen Sanders PhD – both ISAPP Board Members.

free_webinar_gut

Free Webinar: Why is everybody talking about gut microbiota?

Coming up on Thursday, June 28th ISAPP Board Member Professor Glenn Gibson will be featured in a free webinar discussing gut microbiota. Hosted by the British Nutrition Foundation, the webinar will examine what we know about gut microbiota and what remains to be explored. Research on gut microbiota has indicated the gut has a role in metabolism, immunity, and more!

The British Nutrition Foundation says “This free webinar aims to increase understanding of the gut-brain axis and the evidence for the role of gut microbiota in metabolic health and immunity. We are absolutely delighted to have world renowned experts speaking in our programme including:

  • Professor Ian Rowland (University of Reading)
  • Professor Ted Dinan (University College Cork)
  • Professor Glenn Gibson (University of Reading) “

 
Find out more information and register for the webinar here.

argentina_group

ISAPP board members share expertise in probiotic workshop in Buenos Aires

ISAPP board members, Prof. Seppo Salminen and Dr. Mary Ellen Sanders, along with over a dozen other renowned experts from the Southern Cone, Europe and Canada, participated in a workshop in Buenos Aires organized by Ricardo Weill of Instituto Danone Cono Sur April 26-27, 2018. The purpose of the workshop was two-fold. One goal was to share current science about probiotics with each other and with Codex Alimentarius and regulators from Argentina, to encourage a science-based approach to global probiotic standards that may end up with a draft of guidelines to be considered by the Codex Alimentarius late this year. Secondly, the intent is to convert each of the presentation topics into a chapter for a Spanish and English-language book to be published in the fall.

Two experts, Drs. Gabriel Vinderola and Rocio Martin, who participated in this meeting, will also serve as invited experts to the 2018 ISAPP meeting in Singapore June 5-6.

The concepts advanced by ISAPP in its papers on the scope and use of the term ‘probiotic’ and on the concept of core benefits and its regulatory implications were featured at this meeting. “The meeting was organized by Instituto Danone but it was devoid of all commercial content,” said Salminen.

2017_annual_report

ISAPP Releases 2017 Annual Report

The 2017 Annual Report on ISAPP’s activities to advance scientific excellence in probiotics and prebiotics is now available. The Report covers the 2017 Annual Meeting in Chicago IL, as well as the publications, webinars, meetings and other activities accomplished during the past year. Finally, ISAPP is grateful to the 43 Industry Advisory Committee Members who support ISAPP’s endeavors. See more here.

pharmacist continuing ed

Continuing Education Opportunity on Probiotics and Prebiotics Now Available for Pharmacists

ISAPP Board member and Professor of Medicine, Dan Merenstein MD, served as faculty for a new continuing education activity on probiotics and prebiotics. “The Expanding Health Benefits of Prebiotics and Probiotics” was developed by Pharmacy Times and is available free of charge here (registration is required to log in to access the materials).  This concise, practice-oriented review summarizes evidence for probiotic interventions for clinical conditions and is an excellent summary for all healthcare practitioners.

medscape_webinar

Medscape Webinar on Probiotics April 17

Prof. Dan Merenstein MD and Mary Ellen Sanders, PhD will present a 30 min webinar titled, “Navigating the World of Probiotics: Helping Patients Make Good Choices” April 17 at 12:30 ET*. Developed by Medscape, the target audience is medical professionals. Dr. Sanders will provide basic information about choosing probiotics and Prof. Merenstein will discuss the strength of evidence for different clinical applications for probiotics. The webinar is free, but you must register with Medscape to sign up. Register here.

*An earlier announcement by Medscape listed the wrong time zone.

thumbnail of Clinical Guide Canada 2018

Updated Clinical Guide to Probiotics Now Available

Want some guidance on knowing which probiotic products have been tested for which clinical benefits, and understand the level of evidence supporting those benefits? Check out the 2018 versions of Clinical Guide to Probiotic Products Available in USA and Clinical Guide to Probiotic Products Available in Canada. Currently, these are the only 2 geographical regions covered by this initiative, although they are considering expanding to other regions. This guide is updated annually. Some changes for 2018 include addition of new indications ‘Mood and affect’, ‘Liver health’, ‘Weight management’ (Canada) and ‘Seasonal allergies’ and ‘Eczema/Dermatitis-Adult’ (United States). Evidence is reviewed independently by six academic experts and graded as Level I (highest), II or III. A grade of Level I requires evidence from at least one properly designed randomized human trial. This guide is produced by the Alliance for Education on Probiotics, and is an industry funded effort (see industry sponsors for US and Canadian versions).

ISAPP to host live webinar: Microbial metabolism associated with health

Update April 16, 2018:  Recording and slides from the webinar available here.

The International Scientific Association for Probiotics and Prebiotics (ISAPP), in partnership with the International Life Sciences Institute (ILSI) Europe’s Prebiotics and Functional Foods Task Forces, has jointly organized a free webinar, titled Microbial Metabolism Associated with Health. The webinar runs April 12th, 2018 at 15:00 CET, and will highlight recent activities of both ISAPP and ILSI on the beneficial aspects of gut microbial fermentation. The specific focus will be on gut microbiota functions, the effects of the intestinal microbiota on selected nutrients and non-nutrients, and the health benefits of fermented foods. Scientists from both academia and industry may find the webinar of interest. Sign up here.

Webinar participants will learn the status of the science making the links between live microorganisms in the diet and host health. The host gut microbiota is a key factor in determining gut function, nutritional status, biochemical transformations of food and the overall impact on health. This diverse microbial community inhabiting the human gut assists in food metabolism and contributes to the bio-availability of nutrients and non-nutrients; it also has an extensive metabolic repertoire that complements mammalian enzymes in the liver and gut mucosa. Microbial metabolism is an important factor to consider when discussing the management of host health and conditions such as obesity and metabolic syndrome.

The enhanced nutritional and functional properties of fermented foods are being increasingly recognized; not only do microbes transform the substrates and form bioactive or bioavailable end-products, but also, fermented foods contain live microorganisms genetically similar to the strains found in probiotics. The webinar will cover the possible interactions of fermented foods and beverages with the gut microbiota, and potential links to health.

The 90-minute live webinar will be hosted on StreamGo, and will include a question and answer period at the end. There is no cost; however, participants are required to register online beforehand.

Speakers:

  • Effects of the Intestinal Microbiota on Selected Dietary Components
    a) Introduction and Background to the Activity (Dr. Colette Shortt, Johnson & Johnson, UK)
    b) Impact of Intestinal Metabolism and Findings (Prof. Ian Rowland, University of Reading, UK)
  • Health Benefits of Fermented Foods: Microbiota and Beyond (Prof. Robert Hutkins, University of Nebraska, USA)

 

Publications from ISAPP and ILSI-Europe related to the webinar topics:

probiotics webinar

Two Free Webinars on Probiotics!

Both webinars – eligible for continuing education credit – on probiotics involving ISAPP board members are scheduled. The first is scheduled for Thursday, March 15th 11am-noon CST. It  features Mary Ellen Sanders, PhD on the topic of “Be a Pre and Probiotic Pro” and is sponsored by General Mills Bell Institute of Health and Nutrition. Register here.

The second, “Navigating the World of Probiotics: Helping Patients Make Good Choices,” is under development by Medscape. Both Prof. Dan Merenstein MD and Mary Ellen Sanders, PhD will speak during this 30 min webinar. It will take place April 17. Register here.

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Cleveland Clinic’s Center for Microbiome and Human Health recruiting two new or experienced investigators

Take a look at the new opportunities available at the Cleveland Clinic’s Center for Microbiome and Human Health:

Microbial Culturing and Engineering Core Director  

Microbial Sequencing and Analytics Core Director

ISAPP BOARD MEMBERS TO PARTICIPATE IN PEDIATRIC PROBIOTIC CONFERENCE IN ITALY

ISAPP Board Members, Professors Michael Cabana MD MPH and Seppo Salminen PhD, will be participating in the 4th Annual Prebiotics and Probiotics in Pediatrics conference in Bari, Italy April 12-14, 2018. Prof. Cabana will be chairing a panel on colic and will discuss findings from a meta-analysis of L. reuteri as an intervention for colicThis meta-analysis, published December 2017, was the outcome of discussion groups convened at the 2014 and 2016 ISAPP meetings, both led by Prof. Cabana of University of California, San Francisco.

Prof. Salminen will share his decades of knowledge of probiotics, colonizing microbiota and pediatric applications in his presentation titled “Bacteriome and Friends.”

Don’t miss the 4th Annual Prebiotics and Probiotics in Pediatrics conference, which is a unique opportunity to meet major experts in the field while learning the most updated basic and clinical research on prebiotics and probiotics for the developing human. The three-day meeting will cover the major novelties in pediatric gastroenterology, obesity, allergy, nephrology, neonatology and the new scenario on gut-brain communication.

ISAPP RELEASES NEW INFOGRAPHIC: “PROBIOTICS: DISPELLING MYTHS”

How often do you hear information about probiotics that is just plain wrong? Too often write-ups on probiotics in blogs, websites, articles written by the lay press, and even sometimes in scientific journals is not true to the science. The latest ISAPP infographic corrects several common misconceptions about probiotic dose, sweetened probiotic yogurts, fermented foods, and more. In doing so, this infographic furthers ISAPP’s core values of stewardship, advancing the science and education.

This resource was developed by ISAPP’s Science Translation Committee and approved by  the ISAPP board of directors.

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ISAPP works to have evidence-based usage of probiotics to prevent antibiotic-associated diarrheoa implemented in UK

January 12, 2018. Antibiotics are amongst the most commonly prescribed drugs in UK hospitals. However, as well as treating infection they can cause disruption to the gastrointestinal microbiota. This can lead to the relatively common side-effect of antibiotic-associated diarrhoea (AAD) which often delays discharge. More concerning is that a disruption to the normal gut microbiota can lead to reduced resistance to opportunistic pathogens such as Clostridium difficile, leading to C. difficile infection, a potentially severe or fatal infection. Based on the available evidence, probiotics are a safe and effective adjunct to antibiotics to reduce the risk of developing AAD and for the primary prevention of CDAD. The International Scientific Association of Prebiotics and Probiotics has reviewed available data and supports several published assessments, which recommend probiotics as adjunctive therapy for prevention of AAD and CDAD.

This effort was led by Dr. Claire Merrifield BSc MBBS PhD, Speciality Registrar in General Practice, St. Mary’s Hospital, Imperial College Healthcare Trust, Imperial College London and Prof. Daniel Merenstein, MD, Department of Family Medicine, Georgetown University Medical Center and ISAPP Board Member and Treasurer.

Read full recommendation here, which will be sent to NICE and Public Health England.