Page 13 – International Scientific Association for Probiotics and Prebiotics (ISAPP)

CBER to hold public workshop on regulation of biologics

August 19, 2018/in featured, News /by Mary Ellen Sanders

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.

Recommended daily allowance (RDA) for microbes?

August 19, 2018/in Consumer Blog, featured, ISAPP Science Blog /by Mary Ellen Sanders

By Prof. Colin Hill, Alimentary Pharmabiotic Centre, Food for Health Ireland, University College Cork

In this months’ issue of The Biochemist (August 2018) I explored the concept of whether or not there could be a health benefit to ingesting large numbers of safe microbes in our diet (see the open access article here). This was an effort, though I should stress not a scientifically rigorous effort, to consider the long history of encounters between humans and ingested microbes.

This opinion piece was prompted by a series of open questions which have often puzzled me. Why is so much of our immune system focussed on the gut? Why not simply let the microbes and food constituents pass through and get digested without such strict surveillance? Surely it would be more metabolically favourable to only react to those microbes that breach our epithelial barriers? Why does our enteric nervous system devote so much of its resources to the gut? Why is there a generally beneficial effect of many probiotics across so many health conditions? Why is mother’s milk designed to promote the growth of microbes?

Could the solution to all of these questions be down to a very simple answer? Because the gut ‘expects and requires’ constant encounters with microbes for full functionality. Given that humans evolved into a microbial world, and that we have consumed a diet rich in microbes for most of our evolutionary history, it makes sense that our enteric systems would be designed to appropriately deal with microbes of all types, selecting out those which can cause damage and destroying them, accommodating those which will become part of our microbiomes and letting the rest pass through. Surely we are monitoring and controlling our ‘microbial’ organ in the same way that our eukaryotic organs are monitored and controlled.

Could it be that the rise in autoimmune diseases could be, at least in part, due to an immune system primed to expect more microbes than it currently sees? Should we recommend that a daily dose of safe microbes should be included in dietary guidelines – in the form of more safe raw foods, more fermented foods and more probiotics? It must be emphasized that some serious pathogens must be controlled or eliminated from food – not ALL live microbes are safe. But the goal can be to process only when needed for safety reasons, so foods can be a source of the safe microbes they harbour.

Lots of questions, and not many answers. But I for one am taking account of this concept in my daily diet and am deliberately eating more microbes – I’ll let you know how it goes!

ISAPP publishes new paper on “Human Use of Probiotics”

August 17, 2018/in featured, News /by Mary Ellen Sanders

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 21^st 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

August 8, 2018/in featured, News /by Mary Ellen Sanders

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.

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

July 31, 2018/in featured, News /by Mary Ellen Sanders

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.

Probiotics for oral health: start young

July 25, 2018/in featured, ISAPP Science Blog /by Mary Ellen Sanders

By Dr. Mary Ellen Sanders

Prof. Wim Teughels from the Department of Oral Health Sciences, Leuven University, spoke at the 2018 ISAPP meeting on the topic of probiotics and prebiotics for oral health. He embraced the opportunity to speak to this audience in part hoping he could convince researchers to consider incorporating oral health endpoints in their future clinical trials.

He did a spot-on lecture, which precisely summarized available evidence for probiotics and prevention of dental caries, management of periodontal disease and reduction of Streptococcus mutans in the oral cavity. This area of research is gaining traction (see here).

One study he discussed is particularly interesting by Stensson et al. 2014 tracked caries in children at 9 years of age. This single-blinded, placebo-controlled study administered L. reuteri ATCC 55730 to mothers during the last month before their baby’s birth and to the children through age one. The number of children receiving the L. reuteri probiotic without caries was significant higher (82%) than in the placebo group (58%). Although there are studies available that show a larger impact, the interesting aspect of this study is that it tests a very early intervention in life that seems to have an effect up to 9 years later. It is an important paper because it opens up the notion of early interventions in life, during microbial ecology development. The main message here is you don’t need to wait until there are teeth to start working on dental health later in life. In fact, interventions for dental health can start during pregnancy and by this:

The pregnant mother will have less pregnancy gingivitis (Schlagenhauf et al. 2016)
The delivered child will be less susceptible to tooth decay and gingival inflammation (Stensson et al. 2014)

We do not know what would have happened if the probiotics were given during the whole 9 years of life. Dentists who are interested in prevention should be interested in such data.

Several meta-analyses have summarized data for dental caries and management of periodontal disease. These reviews are useful in that they summarize the totality of evidence. But combining data on different strains might not be justified, as different strains may utilize different mechanisms to achieve effects, and therefore should not be considered as the same intervention. See here, here, here and here.

In sum, there appears to be a growing body of evidence that probiotic administration may impact several indicators of oral health: dental caries, gingivitis and periodontitis. More research is needed to understand the impact of probiotic supplementation on the oral microbiota and if clinical benefits are mediated by microbiota changes. It’s also important to understand which strains will deliver the strongest benefits, although L. reuteri has several, positive studies, and the importance of dose and temporal factors with dosing.

Dead bacteria – despite potential for benefit – are not probiotics

July 11, 2018/in featured, ISAPP Science Blog /by Mary Ellen Sanders

Re-posted from an original blog article by Dr. Mary Ellen Sanders, ISAPP Executive Science Officer

At the 2018 International Scientific Association of Probiotics and Prebiotics (ISAPP) meeting in Singapore, two renowned speakers reported unpublished research documenting the health benefits of dead bacteria.

Prof. Hill showed that an inactivated Lactobacillus strain reduced anxious behavior, reduced cortisol levels, and impacted the microbiome in a mouse model. Prof. Patrice Cani showed that heat-killed Akkermansia muciniphila were sufficient to ameliorate obesity and diabetes in mice. Both professors made the point that these microbial preparations were not probiotics.

Prof. Colin Hill is the lead author on the oft-cited and -downloaded (over 40,000 times) ISAPP consensus paper reaffirming the definition of probiotics, which emphasizes that probiotics must be alive when administered. This, of course, does not preclude health effects of dead bacteria. One just must remember that dead bacteria are NOT probiotics. Many different types of microbe-derived substances such as metabolites, cell wall fragments, enzymes, and neurochemicals, can have beneficial physiological effects. A 2016 review by de Almada et al. lists a couple dozen published studies of physiologically active dead bacteria.

Preserving the long-accepted definition of probiotics as ‘live microbes’ is important to the many stakeholders involved in the field. Consumers should be able to purchase a product labeled as ‘probiotic’ and know that it contains an effective level of live microbes. Regulators should know that a product without an adequate level of live microbes is fraudulent if called a probiotic. Scientists should be able to use the term and have reviewers and readers understand that they are referring to functions of live microbes. An agreed-upon definition enables us to be precise when discussing an issue. Saying that because dead bacteria have a health effect and they should be called ‘probiotics’ is like saying that because vitamin D has a health benefit, the term ‘vitamin A’ should include vitamin D.

What are implications of the fact that dead microbes may have health effects?

Stewards of the probiotic field can expect increased frustration with popular press writers. I’ll use a recent example to make this point. The June 2018 Cooking Light Magazine /Special Gut Health Issue included an article that lists sourdough bread as a top probiotic-containing fermented food. When the error about misusing the term ‘probiotic’ to describe a food that contained no live probiotic bacteria was pointed out to the editor by Jo Ann Hattner, MPH RD author of Gut Insight, Cooking Light chose to ignore advice from an expert and justify their mistake by using an irrelevant observation that both live and dead cells in probiotic products may generate beneficial biological responses. Apparently, the expertise she derived from a paper that described the “probiotic paradox” trumped the considered opinions of global expert scientists/researchers and the FAO/WHO, who agree that probiotics must be alive when administered. It’s quite a simple concept. It is true that some dead microbes may have some health benefit (although evidence of such an effect is much lower than that available from controlled human trials on actual probiotics), but they are NOT probiotics.

Confusion. Some audiences will be confused by the idea that probiotics that are killed can have health benefits. Inaccurate writers, such as the Cooking Light author above, will perpetuate this error. This is unfortunate, since the probiotic concept is a long-standing one, backed by much mechanistic and clinical evidence. Conflating probiotics with dead bacteria will lead to confusion over important aspects of an effective probiotic product.

Overages. It is not uncommon for commercial products to be formulated with live microbes at time of manufacture that far exceed the number claimed on the label. This is to assure that the product meets label claim at the end of shelf life, as probiotics often die to some extent during storage. Sometimes this ‘overage’ can reach 10-fold more than the level guaranteed on the product, although more typically it’s 2- to 5-fold. If over the course of shelf life the viable count drops to label claim, then dead microbes may comprise as much as 90% of the microbes present. We don’t know if these dead bacteria – although no longer probiotics – have physiological benefits, as no studies have been conducted on this form of inactivated cells, but it’s an interesting possibility. When we study a probiotic product, perhaps that product needs to be characterized by both the level of live and dead microbes that are present. Means of inactivation, such as heat, pressure, irradiation, or sonication, may impact the physiological activity of the resulting dead cells.

Opportunity. Keeping probiotics alive in commercial products is a challenge. Research such as Prof. Cani’s targets an expanded range of microbes – many isolated from the human GI tract – that cannot be easily grown and stabilized in commercial products. Further, these microbes lack the history of safe use that food-associated microbes have, and so administration of high numbers of these next-generation probiotics will require proof of safety. If these microbes can be killed and still deliver health benefits, the commercialization process could be simplified.

ISAPP may need to consider convening another consensus panel to address these newly emerging terms, such as postbiotic and paraprobiotic. Then we can all be on the same page when using these terms, which have important scientific, nutritional and clinical impact. Of course, even if ISAPP does this, authors may still choose to ignore it.

Efficacy and Effectiveness Studies

July 7, 2018/in featured, ISAPP Science Blog /by Mary Ellen Sanders

By Michael D. Cabana, MD, MPH

In the world of clinical trials, reproducibility (or consistency) of results across different clinical trials improves clinicians’ confidence in an intervention (Hill, 1965). However, when reviewing the evidence for a probiotic or prebiotic supplement, the results are sometimes conflicting. One study claims an intervention may work. Another study claims that an intervention may not work. So how does the clinician deal with this situation?

To know how much confidence to place in any claim of benefit, clinicians need to consider the totality of the evidence and the quality of the studies. One tool is the systematic review process, which in an unbiased manner searches for all studies for a particular intervention, and when possible, combines results into a meta-analysis. The ‘summary’ of these data point to either an effect or no effect. The best way to combine data is using an individual patient-data meta-analysis (IPDMA). In addition, a clinician should determine whether the clinical trial is an effectiveness study or an efficacy study (Singal 2014).

Efficacy or Effectiveness?

Efficacy studies ask, “does the intervention work in a defined (usually an “ideal”) setting?” In general, the inclusion criteria for study participants will be very selective. Patient adherence tends to be closely monitored. The clinicians conducting the trial may be specially trained in the intervention and its application. The intervention occurs in an ideal setting and the risk of other confounding interventions (e.g., unusual diets, concurrent treatments) will be limited.

On the other hand, effectiveness studies ask, “Does the intervention work in a real-world setting?” The inclusion criteria for study participants tends to be less selective. Patient adherence to the protocol is not necessarily strictly enforced. The clinicians conducting the trial tend to be representative of the typical physicians who would treat this condition. The intervention occurs in a more ‘real-world’ setting where the presence of other confounding factors may be present.

For example, two relatively recent studies both examined the effect of a probiotic intervention, L. reuteri DSM 17938 for the treatment infant colic. A study conducted by a team in Italy (Savino et al. 2010) noted that the intervention reduced colic symptoms; however, the study conducted by a team in Australia (Sung et al. 2014) showed no effect on colic.

Why the different results? In the Italian study, all the infants were breastfed. In addition, the breastfeeding mothers limited their dairy intake. The infants tended to be younger (mean age 4.4 weeks) and tended not to have other treatments for colic or gastrointestinal symptoms. In contrast, the infants in the Australian study were breastfed or formula fed. The infants were older (median age 7.4 weeks) and were more likely to have been exposed to other treatment for gastrointestinal symptoms (such as histamine-2 blocker or proton pump inhibitors). The infants were recruited from many different settings such as the emergency department.

Although both the Italian and the Australian study evaluated the same probiotic intervention for the same condition, the studies offer different information in terms of efficacy and effectiveness. Describing a study as either an “efficacy” study or an “effectiveness” study is not always dichotomous. Rather, these studies exist on a spectrum, from being more like an efficacy study versus more like an effectiveness study. In the example above, the Italian study had stricter criteria and fewer confounding factors. As a result, it would tend to be classified as an efficacy study. The Australian study enrolled infants with colic who were older and had a greater likelihood to be exposed to other interventions. This study would tend to be classified as more of an effectiveness study. The fact that the Australian study was a null study does not mean that the intervention was not effective in the ‘real world’. Rather, for the patients enrolled, the treatment was not effective when used in that particular setting and context. Perhaps you may encounter infants with colic who have feeding history and medical history more like the infants from the Italian study. Understanding the context of the studies helps identify those characteristics that may or may not apply to the infants with colic who you may treat in your clinic.

Which is better: Efficacy or Effectiveness?

When developing a new or experimental intervention, an efficacy study might be important to increase the likelihood of detecting a positive change. However, “real world” factors may make a difference in how a product is used. Perhaps an intervention might be inconvenient (due to multiple doses throughout the day) or unpalatable for the patient. Perhaps the dosing regimen is complicated and the primary care providers don’t apply the correct dosing for patients. In these cases, an effectiveness study might be a better guide to how useful the intervention will be in clinical practice.

As a final note, it can be tempting to simply read the abstract of a clinical trial to assess the results of a study. However, in many instances the crucial details of the study (e.g., how the study participants were selected, who was included or excluded, what type of clinical setting was used) are buried in the methods section of the study. Patient diet, exposure to other treatments and comorbid conditions are all common confounding factors encountered in trials evaluating supplements. When reading through the literature and understanding if a study is applicable to your practice, be sure to understand the full context and purpose of the study. “Was this study useful for determining clinical efficacy or clinical effectiveness?” is an important question for readers of probiotic and prebiotic clinical trials. Keeping this question in mind may help you better resolve what may appear to be inconsistency among clinical trials.

Guides for use of probiotics in the clinic – some recent ISAPP initiatives

June 29, 2018/in featured, ISAPP Science Blog /by Mary Ellen Sanders

By Mary Ellen Sanders, PhD

At the ISAPP meeting earlier this month, Prof. Dan Merenstein, MD, presented a summary of recent ISAPP initiatives focused on helping translate the evidence of probiotics and prebiotics into clinical action.

A 2013 paper reported that 87% of hospital formularies surveyed in the United States carried at least one probiotic. Yet when Merenstein looked at the names of the products tested, many were not supported by evidence for such uses. This highlights the need for clinicians to have access to clear, evidence-based probiotic use guidelines.

ISAPP has worked through a variety of avenues to get information into the hands of clinicians. It has supported continuing education credit activities, webinars, collaboration with clinical organizations to develop guidelines, publications in clinical journals, presentations at clinical meetings, and simplified summaries using infographics and videos. Some examples include the following.

World Gastroenterology Organisation Global Guidelines – Probiotics and Prebiotics

This document is the most visited and downloaded of all WGO guidelines. In 2017, under the leadership of Prof. Francisco Guarner, MD PhD, this document was updated. Three current ISAPP board members were part of the process and ISAPP provided funding. See here.

Petitions

ISAPP petitioned the United States Preventive Services Task Force to examine the role of probiotics in preventing antibiotic-associated diarrhea. They considered the petition, but didn’t feel it fit their mission.

ISAPP petitioned American Academy of Family Physicians to consider reviewing the evidence for probiotics for AAD to include in their evidence-based guidelines. This is under consideration.

After attending 2017 ISAPP, Dr. Claire Merrifield BSc MBBS PhD led an effort to have NICE Clinical Knowledge Summaries mention probiotics for AAD in an effort to get local groups to adopt guidelines. This has met with limited success. See here.

CME or CE activities

On April 17, 2018, Merenstein and Mary Ellen Sanders PhD served as faculty for a CME-eligible webinar sponsored by Medscape on “Navigating the World of Probiotics. Helping Patients Make Good Choices”. The activity is available on Medscape’s website here.

In February 2018, Merenstein published a CE activity with the Pharmacy Times titled “The Expanding Health Benefits of Prebiotics and Probiotics”. See here

Upcoming in October 2018, Merenstein will present “Probiotics and the GI Tract. What Should a Busy Clinician Know” at the American Academy of Family Physicians Annual Conference. This conference is attended by over 4,000 physicians and is focused on clinical practice. The event, eligible for CME, will be recorded and made available after the live presentation.

ISAPP co-founder, Prof. Glenn Gibson has or will present 6 lectures over 2017 and 2018 on the topic of “The Learning Curve for Probiotics and Prebiotics.” These lectures are available for CME credit and are targeted to family doctors, gastroenterologists, pediatricians, and dieticians in the UK.

Numerous CME presentations over 2017-2018 have been given by ISAPP board members:

M.D. Cabana:

“Probiotics: Friend or Folly?” American Academy of Pediatrics National Conference and Exhibition. Chicago, IL. September 17, 2017. The audience was about 450-500 clinicians.
“Probiotics in Primary Care Pediatrics: Diarrhea, Colic & Eczema.” American Academy of Pediatrics California Chapter 1 Meeting. 300 clinicians
“Probiotics for Colic?” Zuckerberg San Francisco General Hospital. Department of Pediatrics Grand Rounds. San Francisco, CA.
“Probiotic Interventions for Colic” UCSF Benioff Children’s Hospital, Oakland.

Reid:

“Effects and importance of microbiota on urogenital health in women.” 16th Annual Congress of Gynecology and Obstetrics, Antalya, Turkey. 300 obstetricians and gynecologists.
“Probiotics to whom for what?” Health World Ltd International Congress Natural Medicine 2017, Hunter Valley, New South Wales, Australia,.601 healthcare practitioners and naturopaths.
“The microbiome and how it relates to maternal/newborn care.” The Graham Chance Lectureship, Perinatal Research Day, London, ON. 100 neonatologists and pediatric experts.
“Microbes and the brain.” Integrative Healthcare Symposium, New York City. 500 naturopaths and various specialists.
“Probiotics and detoxification.” Environmental Health Symposium, Scottsdale, Arizona, 8th April. 500 naturopaths and various specialists.

Webinars

On June 28, ISAPP co-founder, Prof. Glenn Gibson, will present a webinar along with Profs. Ted Dinan and Ian Rowland titled “Why is everybody talking about gut microbiota?” Sponsored by the British Nutrition Foundation, this webinar will target healthcare professionals in the UK and Europe. See here.

Publications in clinical journals

Several ISAPP board members

Evidence-Based Probiotic Use in Family Medicine. Submitted, Journal of Family Practice. Merenstein/Sanders/Tancredi
Probiotics for Human Use. In press, Nutrition Bulletin. Sanders/Merenstein/Hutkins/Merrifield
Probiotics and prebiotics in intestinal health and disease: from biology to the clinic. Invited review in preparation, Nature Reviews Gastroenterology and Hepatology. Gibson/Reid/Sanders/Merenstein
Clinical perspectives of prebiotics and synbiotics. In preparation, Gastroenterology. Gibson/Quigley

Featured on ISAPPscience.org

Infographics

Videos

What is a probiotic?
Health benefits of probiotics
Are all probiotics the same?
How to choose a probiotic

General guidelines for choosing probiotics and prebiotics

Some initiatives that Merenstein championed were a direct result of ideas generated during the discussion group he led during the 2017 ISAPP meeting in Chicago.

Image courtesy of nursingschoolsnearme.com/

East meets West at ISAPP’s first meeting in Asia

June 27, 2018/in featured, ISAPP Science Blog /by Mary Ellen Sanders

By Mary Ellen Sanders, PhD

The International Scientific Association for Probiotics and Prebiotics (ISAPP) recently convened its first meeting held in Asia, with the modern hub of Singapore as a host city. The meeting featured a two-day open registration meeting, attended by nearly 250 scientists, health professionals, and industry representatives, and a third day of smaller discussion groups by invitation. The meeting provided a rare opportunity for non-members to attend. It provided a dynamic forum for sharing different clinical experiences and regulatory nuances amongst the continents, as well as allowing attendees to better appreciate the research being performed in the Asian region.

Here are a few speaker highlights:

Mimi Tang MD

Tang presented the results of a double-blind, randomized controlled trial examining the effect of probiotic supplementation combined with oral immunotherapy (OIT) to decrease the risk of peanut allergy in children. Peanut allergy is one of the fastest growing food allergies in children. In the Probiotic and Peanut Oral ImmunoTherapy [PPOIT] study, children randomized to the intervention group had increased rates of sustained responsiveness to peanut several weeks after discontinuation of the treatment. Tang discussed the implications of the study, as well as current, larger clinical trials that are building upon these findings.

Dr. Bruno Pot

The Lactobacillus genus is taxonomically abnormally heterogeneous. Currently, the 231 Lactobacillus species range from a genome size of 1.23 – 4.91 megabases, have a GC content of 32-57% and an average nucleotide identity that is typical for a family or worse. Such ranges are far beyond what is acceptable for a bacterial genus. Experts are recommending that the current genus should be split into 12 new genera. Some well-known lactobacilli would be re-named, which may have important repercussions commercially and legally.

Profs. Colin Hill and Patrice Cani

Hill described how lactase in yogurt cultures improves lactose digestion; he emphasized how mechanisms that drive probiotic activity are complex. Some scientists are searching for a single molecule that drives probiotic health benefits—but it is unlikely to be found.

Hill noted even inactivated (non-living) microbes may have health effects—for example, a study showed that a dead Lactobacillus strain reduced anxious behavior, reduced cortisol levels, and impacted the microbiome in a mouse model. Work by Prof. Patrice Cani showed that heat-killed Akkermansia muciniphila were sufficient to ameliorate obesity and diabetes in mice. Does this suggest that we will need to start quantifying probiotics based on biomass as well as CFU?

Profs. Hani El-Nezami, Gregor Reid and Akihito Endo

These three speakers illustrated the important impact of environmental toxins (extremely potent aflatoxins, pesticides, and heavy metals) on humans and wildlife. They showed how certain probiotic strains can decrease aflatoxin absorption and even degrade them; sequester heavy metals and pesticides to reduce their uptake; and enhance resistance to honey bee colony collapse disorder that threatens the world’s food supply.

Prof. Wim Teughels

To date, 11 studies have been published on probiotics with a low ‘number needed to treat’ for prevention of dental caries in infants, toddlers, and adults. One study showed the benefits of administered L. reuteri, following children for nine years after they were treated as infants before any teeth had emerged. Also, data exist for probiotics influencing other oral health endpoints, including periodontal infections, oral candida infections, and halitosis.

The discussion groups on day three of the conference addressed a range of topics:

Possibilities to harmonize global probiotic and prebiotic regulations—Chaired by Seppo Salminen (Finland), Yuan Kun Lee (Singapore), and Gabriel Vinderola (Argentina)
Fermented foods for health: East meets West—Chaired by Bob Hutkins (USA), Paul Cotter (Ireland), and Liu Shao Quan (Singapore)
Potential value of probiotics and prebiotics to treat or prevent serious medical issues in developing countries—Chaired by Daniel Merenstein (USA), Reuben Wong (Singapore), and Colin Hill (Ireland)
Prebiotics as ingredients: How foods, fibres and delivery methods influence functionality—Chaired by Glenn Gibson (England) and Karen Scott (Scotland)

These workshops often produce peer-reviewed publications based on the discussion outcomes, so stay tuned for these developments. (See here for a list of ISAPP publications.)

The full meeting report is being developed and will be posted on the ISAPP website shortly.

The 2019 meeting will return to ISAPP’s normal format, hosted by Dr. Sarah Lebeer in Antwerp, Belgium.

Welcome Seppo Salminen – ISAPP’s New President

June 19, 2018/in featured, News /by Mary Ellen Sanders

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!

ISAPP’s First Meeting in Asia is a Huge Success

June 8, 2018/in featured, News /by Mary Ellen Sanders

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.

ISAPP’s Outgoing President: Karen Scott

June 7, 2018/in featured, News /by Mary Ellen Sanders

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 on Probiotics – Now Available!

June 4, 2018/in featured, News /by Mary Ellen Sanders

“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.

ISAPP is coming to Asia – the hidden reason

May 19, 2018/in featured, ISAPP Science Blog /by Mary Ellen Sanders

By Prof. Glenn Gibson

In just a few days ISAPP will host its first meeting outside of Europe or North America, when we have an open conference in Singapore^1,2. There are about 200 registrants and we cannot wait. The meetings are always scientifically informative but fun also. These are main drivers behind our annual jamboree, but this year there is another task…… I am hoping that first timers to ISAPP, and particularly our Asian friends, break with tradition and pronounce the name of the organisation correctly.

I have written one blog in the 56 years of my existence. This first was last year on the various social events we have at the meetings. But this was prior to Chicago in 2017, where we had a bowling alley experience. My PhD student Xueden Wang (Holly) has never let us forget her winning efforts at this:

The above picture and Holly’s endless bragging came to an abrupt end however, when we had our lab Christmas party in December³ – also at a bowling alley this time in Wokingham UK:

Let’s call that revenge of the supervisor shall we? The open top bus parade is now cancelled Holly I am afraid. By the way, if you don’t know what Chicago or Wokingham look like, then both are pictured below. I will leave you to guess which is which:

Anyway, I disgress (justifiably). This is therefore my second blog, and there is a reason for dusting off the quill pen and rehearsing the hieroglyphics once more.

In the last few years ISAPP has published 2 consensus papers, one on probiotics and one on prebiotics⁴. What we cannot agree on, however, is how to say the name of our esteemed society. Some say ISAPP with the I as “eye”, while others say ISAPP (with the I as in sIt). Admittedly, there is a slight bias in numbers as it is possible to count on the fingers of one finger the number of people who use the latter. It is me. So, that makes about 852 attendees at previous ISAPP meetings incorrect.

Think of the full name of the ISAPP organisation and say it to yourself now…………………

Did anyone say Eye-Nternational? Or did you say International?

At this stage, I should just say that the case for the prosecution is concluded and no further witnesses your honour!

However, let’s look at things a little more closely. If the anarchists, heretics and Eye-Sappers get their way then we may need to change the logo of the organisation to:

We see the letter “I” in front of many things these days such as i pad, i mac , i max, i alex cross, i pod, i robot. A quick search of the internet (or as some say eyeNternet) suggests that the “I” can stand for individual, imagination or internet, but usually refers to intelligent. We might have to live with ISAPP standing for intelligent sapps. Here is a picture of 2 saps:

Still, 852 people can’t be wrong. I’ll put that another way – 852 people are wrong. So the spotlight turns to Singapore to show us the light, the truth and the way forward.

But……. It gets worse. The terms probiotic and prebiotic are not used on products in Europe now as they are an implied health benefit. Let’s put aside that the very body who devised this “rule” have turned down all but about one health claim. If we go along with this puffed up lunacy⁵ then we might have to call ISAPP:

International Scientific Association for @%?!&.. and @%?!&..

Maybe we can get away with just using the first letters of these disgustingly offensive, abhorrent and abusive terms. So, ISAPP becomes:

International Scientific Association for P@%?!&.. and P@%?!&..

It still does not seem right, so ISAPP becomes:

International Scientific Association for PAP

Now we are getting somewhere, as PAP means “Noun. 1. Nonsense, rubbish. 2. Faeces. Verb. To defaecate. e.g. ‘He was so scared he papped his pants.’.” This embodies exactly what ISAPP is all about and where pro/prebiotics work!!! So, I propose another new logo:

¹I’ll be flying there with British Airways. One highlight is always the safety demo where they say “in the unlikely event that the plane should land on water.” I always feel that “unlikely” is not quite definitive enough. If you were to ask at check in about the chances of the 777 landing on water and the reply was “er… well…on balance it is unlikely”, you would probably not board the old crate.

²Travel tip: Always aim for row 13 and upon reaching it say “oh no, me and my luck, I’m in death row again”, it often leads to vacating of the seat next to you.

³Also attended by a group of leading food science researchers, who face such crucial issues as:

What is there in a chicken that makes an eggshell?
Why do we not eat turkey eggs?
Why is marmalade not just called orange jam?
How is some cheese orange when it made from milk?
Why are small chocolate bars called “fun size” when they are about half of what they should be?

⁴By the way, in the olden days (1995) I wanted to call prebiotics parabiotics. Only because MASH was on TV at the time and featured paramedics. So these could be known as biotics that help medics.

⁵Please note that these opinions are those of the author and do not represent the views of EYESAPP, aside from Gregor.

Free Webinar: Why is everybody talking about gut microbiota?

May 17, 2018/in featured, News /by Mary Ellen Sanders

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.

ISAPP board members share expertise in probiotic workshop in Buenos Aires

May 11, 2018/in featured, News /by Mary Ellen Sanders

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.

ISAPP Releases 2017 Annual Report

May 3, 2018/in featured, News /by Mary Ellen Sanders

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.

Continuing Education Opportunity on Probiotics and Prebiotics Now Available for Pharmacists

April 12, 2018/in featured, News /by Mary Ellen Sanders

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 on Probiotics April 17

April 10, 2018/in featured, News /by Mary Ellen Sanders

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.

Updated Clinical Guide to Probiotics Now Available

April 9, 2018/in featured, News /by Mary Ellen Sanders

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).

The need to improve in vitro testing of future probiotics

April 4, 2018/in featured, ISAPP Science Blog /by Mary Ellen Sanders

By Prof. Gabriel Vinderola, Instituto de Lactología Industrial (INLAIN, UNL-CONICET), National University of Litoral, Argentina and Prof. Seppo Salminen, Functional Foods Forum, Faculty of Medicine, University of Turku, Finland

In a recent review we compared the in vitro tests for probiotics to the in vivo studies to observe if correlations exist.

Lactobacilli and bifidobacteria have been traditionally accepted as probiotics with the basis of their long history of safe use and reported benefits. However, new species, some of them never previously consumed, are being proposed as probiotic candidates. Some basic tests have been suggested for probiotic candidates, but there is a lack of standardized in vitro protocols for the selection of new strains of probiotics. Additionally, safety assessment of new species may have to cover aspects never hitherto considered.

Vinderola and coworkers reviewed the common in vitro selection tests such as exposure to low pH and bile salts, adherence to intestinal mucus or cell lines and prokaryotic-eukaryotic co-cultures that have been traditionally used to predict the functional properties of probiotics. At the end, the correlation of in vitro results with in vivo performance remained ambiguous. This poses challenges to research as newly proposed probiotics include often novel species never hitherto administered to humans.

The question of safety has been handled by the European QPS system and the US GRAS notifications but questions on efficacy, particularly concerning health claims, would benefit from predictive in vitro tests. These appear to predict more technological properties than safety and efficacy or health benefits.

New standardized systems need to be developed along with detailed sequencing information to be able to predict novel probiotic properties before they are tested in expensive human intervention studies. If the predictive capacity of in vitro tests fails, many potential probiotics will be left on the way from the laboratory to the application in humans and animals.

The lack of standardized protocols for in vitro and in vivo studies hampers comparison of the potential of new species and strains. There is thus a need to conduct selection of potential probiotics in a more robust manner and to focus on well-defined in vitro and in vivo (animal) studies able to predict health benefits that must still be confirmed in human interventions studies with the smallest possible error margin.

For additional perspective on this issue, see blog by Dr. Mary Ellen Sanders: Probiotic Screening: Are in vitro Tests Informative?

Reference: Vinderola G, Gueimonde M, Gomez-Gallego C, Delfredico L, Salminen S. Correlation between in vitro and in vivo assays in selection of probiotics from traditional species of bacteria. Trends in Food Sci Tech 2017: 68:83-90.

Those who can’t do science, do science communication?

March 28, 2018/in featured, ISAPP Science Blog /by Mary Ellen Sanders

By Dr. Colin Hill

See what I did there? I used a title which I hope will attract the attention (or wrath) of science communicators but then put a question mark which allows me to disagree with the hypothesis posed – a good science communication bit of ‘click-baiting’.

But now that I have hopefully got your attention, let me expand on my views of how science is communicated. By way of disclosure, I am involved in a research centre, APC Microbiome Ireland, which has a mandate from Science Foundation Ireland for each scientist to actively participate in public engagement. This is something I initially resented, on the premise that anything mandatory should be resisted, but I have begun to appreciate that it is an important obligation for active scientists to support science communication – hence this blog and sporadic attempts to tweet and engage with the outside world. We are very lucky to have dedicated and talented science communicators in the APC, with an extraordinarily wide brief of engaging with schoolkids, students, clinicians, industry and the general public. To argue against my provocative title, let me make it clear our APC communicators are highly qualified and talented scientists who could easily have ‘made it’ in scientific research in academia or industry, but chose to develop their skills in science communication.

My main issue is the widespread attempts to portray science as ‘fun’ to young people. Most science communicators dealing with adults do a great job, albeit unfortunately the message is sometimes coloured by the need to make the story interesting by linking it to a headline proclaiming a ‘new cure for cancer’ or a ‘breakthrough on superbugs’. But it is mainly the manner of communicating to younger people that worries me. Scientists are largely perceived as nerds by the general public, and certainly by print and online media, even more so again by film and TV, but perhaps the most by scientists themselves. Is this why we feel a need to persuade people that scientists are actually fun-loving and cool? Perhaps the only sure way of not appearing cool is for adults to try to explain to a young person just how cool they are. Obviously, using the word ‘cool’ so often makes it abundantly clear that I am certainly NOT cool. ‘Serious’ professions like medicine, law, or business do not try to persuade people that their careers are fun. If you don’t believe me then try a simple exercise. Do a Google Image search for ‘science’, and then for ‘law’ or ‘business’ or ‘medicine’. As a hint, one set of images is dominated by cartoons, the other three are not.

I also cringe when I see science programmes on TV aimed at younger people, often with ‘zany’ presenters showing how science can be so much fun. Let me quote from a 2015 Sunday Times TV review of an Irish science programme. ‘Silliness in the name of science was a recurring feature of [programme name omitted], a series that veered wildly between the youthfully exuberant and the childishly skittish…. Science TV (presenters) have been supplanted by giddy MCs who seem capable of speaking only in a cheerleading register’. As a contrast, David Attenborough is the ultimate science presenter, never talking down to his audience, never dumbing down difficult ecological concepts, but retaining a genuine enthusiasm and deep knowledge of his subject. He is never fun, but his message is clear and engaging.

Surely it is more important to communicate just how important science is to modern life and invite the next generation to join in, rather than to emphasise science as a fun career. How could you get up every morning to a fun job? You would go mad within a few weeks. I have never found science to be fun. I have found it to be challenging, frustrating, exciting, exacting, rewarding and infuriating in equal measures. If you regard being the first person in human history to learn something new about our universe as ‘fun’, then so be it. I would rather characterise it as a humbling and thrilling experience. We should be clear in our messaging. Scientists conceived and created the world we live in. We (the computer scientists and physicists) made possible the smartphone or laptop upon which you are almost certainly reading this. You may well only be alive because of medical interventions such as antibiotics provided by us (the chemists and biologists) and you can only be fed in such large numbers as a result of our efforts (animal and plant scientists, food scientists). Why then do we feel a need to claim ‘science is fun’ in order to attract the brightest and best young people into science?

This blog is aimed both at science communicators and scientists alike. We work in the most important career of all, in the only profession that can ensure a future for our race and our planet. We have the most important roles in all of human activity – discovering and understanding our universe. So let’s try again with a new message to attract the brightest and the best – “Science is hard, but that is exactly what makes it worth doing”.

ISAPP to host live webinar: Microbial metabolism associated with health

March 15, 2018/in featured, News /by Mary Ellen Sanders

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 12^th, 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:

Systemic review of the effects of the intestinal microbiota on selected nutrients and non-nutrients. Colette Shortt et al. 2018.
Gut microbiota functions: metabolism of nutrients and other food components. Ian Roland et al. 2017.
Health benefits of fermented foods: microbiota and beyond. Maria L Marco et al (including Robert Hutkins). 2017.

Academics working with industry

March 12, 2018/in featured, ISAPP Science Blog /by Mary Ellen Sanders

by Dr. Colin Hill, APC Microbiome Ireland & School of Microbiology, University College Cork, Ireland

Many scientists have reservations about working with industry. While characterising it as going over to the dark side might be an overstatement, there is a certain wariness that principles may have to be compromised (in terms of the ambition of the work and the freedom to follow your nose that is the supposed hallmark of ‘pure’ research), dull routine work may have to be performed, and publication in the best journals will be unlikely. There may also be concerns that students or post-docs working on ‘industry’ projects may suffer from these constraints, which will restrict their career development. There can also be a perception that the ‘best’ scientists work on fundamental problems, unfettered by the demands of industrial partners or short-term commercial goals. Some of you reading this opening paragraph may be amused at the simplicity of this stereotyping – “no one really thinks like that” – but I can assure you that some do, including a younger version of myself.

I have only really worked closely with industry in the last decade. Before that, I wrote grants which assured potential funding agencies that what I wanted to investigate was incredibly relevant and important, would represent good value for the taxpayers’ investment, but was just a ‘little bit too early’ for industry to take on. I genuinely believed this for the most part, although part of getting older is learning that fooling myself has always been a much easier task than fooling anyone else. Nonetheless, I managed to forge a career in science. I had a reasonable success rate of about one in four or five applications, which still seemed a poor return for the effort involved. I would take my hard-earned funding and do my best to deliver on the promises I had made. On occasion, the grants were successful, and we ended up filing a patent or developing a prototype or a process and essentially delivering on the promises made in the grant application. But all too often I discovered that what we had achieved, or the problem we had solved, was not really the burning issue I had thought it to be, or at least could not be translated for the benefit of society without suitable industry partners. In essence, we had self-tasked ourselves to solve a problem that no one really needed to be solved (or, at least not yet, or not in the precise manner we had solved it).

Of course, on occasion I was successful in getting truly ‘fundamental’ or ‘basic’ grants which were simply aimed at generating knowledge, and these were absolutely vital in developing new skills and opening up new research areas and possibilities. However, over the past decade or more, I have begun to work closely with industry partners. At first, this was driven by changes in funding policy in Ireland which linked scientific excellence to industry relevance – grants had to pass rigorous peer-reviewed scientific assessment, but also had to be validated by an industry partner willing to put skin in the game in the form of co-funding. This necessitated finding industry partners and identifying a research problem together, before developing a solution. I hope that now I have a perspective on both aspects of scientific research – often simplistically referred to as basic versus applied research – and I have good news. Working with industry can be just as scientifically rewarding as not working with industry.

As I have experienced it, working with industry has several obvious advantages.

Relevance. You know the research problem posed is one that genuinely needs solving, and the industrial partner for any solution you may develop is already engaged.
Funding. Once you begin to work with an industry partner, the prospect of getting funding is much higher than in most competitive grant applications and the amount available may be defined by the extent of the problem, not the limit of a particular funding call.
Intellectual capital. Most of the industry people you will be dealing with are also scientists, and they are just as clever, or far cleverer, than you (or me). They will have defined goals but also have the same scientific curiosity which can be harnessed within the project.
Flexibility. If you have embarked on the project and you find you have gone down a blind alley, it is usually possible to have a discussion with your partners and change the project design. You don’t have to go back to the funders for permission to adjust the dreaded Gantt chart and ‘deliverables’, or have to justify to grant reviewers why you have gone off track. If a project extension is required you can often simply argue for it, no need to write a new grant and experience the inevitable downtime ‘between funding’.
Urgency. Working with a student or a post-doc on a problem can be exciting, but sometimes a good or a bad result seems important only to the two of you. It really adds urgency when an industry meeting is looming on the horizon, when you know the funders are directly invested in the outcomes of the experiments, and when the pressure really builds on the team. In these moments some intense brainstorming and problem-solving can be required, which can create a real sense of excitement within the project and which can be a tremendous learning experience for junior members of the team.
Career development. Most of the students and postdocs in the lab will not end up in academia, nor should they. It is valuable training for young scientists to have a first-hand exposure to industry-based science so that they can make an informed choice on their next step in their career.

Are there negatives? Well, honestly, not all industry sponsored research involves cutting edge science. But if you are completely uninterested in the outcomes then don’t take it on. What about bias? Does industry funding create a bias towards positive outcomes? I genuinely have not found this to be the case. Reputable industry partners have no interest in biased results, since the company’s reputation is at stake and of course, no one is more invested in the scientific validity of their product than the industry partner. And given that science is ultimately self-correcting no reputable scientist wants to be associated with misleading outcomes. Individuals on either side can make mistakes or display bias, but that is no less true in the basic sciences.

The ideal academic-industry relationship recognises that there have to be rewards for both partners. For both it is really important that the experiments be conducted to the highest possible standards with appropriate controls. For the academic the right to publish the results in a timely fashion is particularly important when junior scientists are involved and a clear understanding of how results will be disseminated must be reached before the collaboration gets underway. For the industry partner, it is important that the work stay focused on the agreed goals of the project and not veer off into the ‘nice to know’ rather than ‘need to know’ areas of the research problem. As in most things, problems can be avoided by having a clear agreement on the goals, methods and publication strategy and having transparent reporting structures. Further, both sides must put effort into maintaining a good working relationship.

Finally, it is not a binary choice – working with industry obviously does not close off any other type of research you may want to perform. You can still write grants and get funding from other sources. In fact, I would propose that the ideal research mix requires an element of exploratory science to keep the laboratory fresh and industry-funded science to ensure relevance. And when in doubt always defer to the great Louis Pasteur, who said “There are no such things as applied sciences, only applications of science”.