What Probiotics Can Do for You

… A quick guide to probiotics

IPA Europe, March 2017

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Contents …

WHAT ARE PROBIOTICS? ....................................................................................................................................................... 3

WHY PROBIOTICS ARE IMPORTANT? ................................................................................................................................... 3
WHAT DOES CURRENT SCIENCE SAY ABOUT THE BENEFITS OF PROBIOTICS? .......................................................... 4
WHAT ARE THE DIFFERENCES BETWEEN: .......................................................................................................................... 6
A) PROBIOTICS AND FERMENTED FOOD PRODUCTS ........................................................................................ 6
B) PROBIOTICS AND PREBIOTICS ......................................................................................................................... 6
CAN I ADD PROBIOTICS TO MY DIET? .................................................................................................................................. 6
WHERE TO FIND PROBIOTICS ............................................................................................................................................... 7
HOW TO CHOOSE THE RIGHT PROBIOTIC .......................................................................................................................... 7
HOW TO TAKE PROBIOTICS................................................................................................................................................... 8
IN SUMMARY … ....................................................................................................................................................................... 8
ANNEX....................................................................................................................................................................................... 9
EXAMPLES OF NATIONAL GUIDELINES ON PROBIOTICS ................................................................................................ 10
REFERENCES ........................................................................................................................................................................ 11

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What are probiotics?
The term probiotic is derived from the Latin explain what the gut microbiota is and
preposition “pro,” which means “for” and how it works. The gut microbiota, formerly
the Greek word βιωτικός (biōtikos) called ‘gut flora’, represents a dynamic
meaning “bios” or “life”. The idea that community of micro-organisms that live in
micro-organisms could be beneficial for our intestine. The best way, perhaps, to
human health was first developed by Elias describe the complex interactions that take
Metchnikoff in 1900. He proposed that place in our gut, is through the following
aging is caused by toxic bacteria in the gut analogy that Stephen O’Keefe, a
and that lactic acid producing good bacteria gastroenterologist from the University of
could prolong life1. At the time, Pittsburgh uses: "There are hundreds of
Metchnikoff’s theory was ground-breaking. species of bacteria in the colon, and they're
more like an orchestra … they play
This later inspired others to begin together to come up with a final sound"3.
investigating a causal relationship between
intestinal health and micro-organisms such Did you know that every person has
as bacteria and yeasts. This eventually led his/her own unique GUT MICROBIOTA?
to the worldwide development, manufactu- It’s just like an identity card!
ring, sales and consumption of fermented
milk drinks and products. Whilst the
definition of probiotics has evolved
throughout the years, the most recent and
generally accepted definition among the
scientific community, states that probiotics
are “live micro-organisms which when
administered in adequate amounts confer
a health benefit on the host” (From FAO The gut is the main theatre of action for
working group 2001 recommendations)2. orally ingested probiotics. For centuries,
the gut was viewed simply as a biological
“food processor”. It is now recognized as
In other words, when consumed in a highly complex ecosystem with a
sufficient quantities, these tiny single-celled surface area of 300 m2 and is the
organisms (mainly bacteria and yeasts) are location of 70% of our immune cells and
100 million neurons.
good for your body and can help you stay
healthy. The gut is the primary interface between
the host and the external world, acting
first as a barrier but also behaving
Why probiotics are important? dynamically to sense and transform
Even though there is growing evidence that ingested substances. Of course, this
already complex organ is also home to
probiotics can have beneficial effects
our microbiota – the community of 1014
beyond gut health, we will start with the (100 billion) individual microorganisms
latter as it is the most studied up to now. that have been described as a ‘virtual
To help you understand the effects of organ’ within the gut.
probiotics on our gut, we should first

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A well-balanced microbiota is essential for Probiotics should be considered as
the normal functioning of the body, transient micro-organisms that have
because this is when it can optimally help beneficial effects as they pass through the
us digest certain foods, produce vitamins, gut. They are described by their genus,
support our immune system and act as a their species and their unique strain
barrier against other micro-organisms that designation.
may be harmful to the structure or function
of the body4.

Although our gut microbiota is relatively

stable, it is prone, throughout our entire life,
for variations caused by age, diet,
pregnancy, and environment. Illness,
stress, travelling or use of medication such
as antibiotics can also cause imbalances in
our gut microbiota5,6.
This detailed description is essential as
probiotic functions and effects can be
strain-specific: for example, the effects of
Lactobacillus rhamnosus IPA-1 can differ
from those of Lactobacillus rhamnosus
IPA-2. For micro-organisms, differences
between specific strains can be compared
to individual differences between people:
we are all human, but each individual may
have different skills.

Now that you know a little bit more about

how the gut functions and how probiotics
work, let’s find out what scientists suggest
Probiotics can have effects that are about the benefits that probiotics can
considered beneficial for our gut microbiota confer.
as they can help restore and maintain the
beneficial micro-organisms in our digestive What does current science say
system. They may also help the gut
about the benefits of probiotics?
microbiota resist to the growth of harmful
There is no doubt that research on
micro-organisms. A variety of bacteria have
probiotics is a mainstream scientific area:
been studied to explore their beneficial
almost 11,000 papers have been published
effects, including various Lactobacillus and
on the topic in peer-review scientific
Bifidobacterium strains, as well as the
journals in the last 50 years. However, it is
yeast Saccharomyces cerevisiae var.
really in the last decade that research on
boulardii and some Bacillus species.
probiotics has exploded. This is part due to

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the advent of new scientific technologies, There is also considerable research
but also because of an increasing interest underway in additional gut disorders,
among consumers and clinicians seeking lactose intolerance, irritable bowel
safe and validated alternatives to syndrome, inflammatory bowel disease.
pharmaceuticals to assist the general Beyond the gut, depression, brain function,
population in maintaining health and anxiety, blood cholesterol, urinary/vaginal
wellness. tract infection, and different types of allergy
might be also influenced by the gut
Taken altogether, these publications microbiota8-14.
convincingly describe different beneficial
effects during human interventions. The
current scientific consensus is that
probiotics are most effective in conditions
related to the digestive tract and the
immune system. “When you look at
findings from a variety of studies on
different end points that look at some
aspects of digestive health, the combined
evidence suggests that digestive health is
a core benefit of many probiotic micro-
organisms” says Mary Ellen Sanders, an
internationally recognised scientist in the
area of probiotic microbiology7.

The quality of evidence is such that several

medical and scientific organisations have
issued evidence-based guidelines. These
organisations highly recommend the use of
probiotics in different gastrointestinal
symptoms or diseases for children and
adults. In addition, international and Scientists nowadays recognise that the
national clinical guides and scientific various interactions between food and the
research suggest that different types of gut microbiota have a profound impact on
probiotics can have different positive our health. According to the scientific team
effects on our health8-13. of the EU-funded project MyNewGut, a
large amount of scientific evidence
For instance, the World Gastroenterology suggests that “the gut microbiota (and its
Organisation (WGO) concluded in 2011 collective genome) play a key role in the
that probiotics are indicated for prevention communication and function of the gut and
of antibiotic associated diarrhoea and for different organs and systems, and thereby,
alleviating some symptoms of irritable in human development, physiology and
bowel syndrome. health”15.

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In our Western diet, the consumption of live
microorganisms as part of the daily diet has
gradually decreased over the last decades.
Earlier sources of living microorganisms
were mainly the many different types of
fermented foods, in absence of
refrigeration and deep freezing.

The reduction of fermented food

consumption has been linked to an The production of yoghurt always needs a
increased incidence of immune related combination of two different lactic acid
diseases such as allergy, autoimmunity bacteria, Lactobacillus bulgaricus and
and even autism spectrum disorder. Streptococcus thermophilus.
Probiotics have been proposed as an
alternative source of living bacteria.

Therefore, their recommendation is that if

What are the differences
fermented products contain micro-
between: organisms that have been defined, and
have been shown to confer some health
a) probiotics and fermented food benefits, then these fermented foods could
products be considered to contain probiotics16.

Probiotics are specific micro-organisms

with health benefits. Fermented products b) probiotics and prebiotics
may be healthy and contain, as a result of Prebiotics are typically non-digestible fibre
fermentation, live micro-organisms that compounds and have distinct functions.
may be related to know probiotic micro- Up-to-date research indicates that they can
organisms. assist specific members of the gut
microbiota and also probiotic micro-
However, not all of these microbes from organisms added from the diet, by helping
fermentation are considered, by the them grow within the gut environment. The
scientific community, as probiotics. combination of probiotics and prebiotics,
commonly known as synbiotics, has been
Furthermore, because the term “probiotics” reported to have beneficial effects on our
is often misused, especially in non-food intestinal metabolism and immune
14, 17
products claiming to contain probiotics, function .
scientists suggest that “even if a micro-
organism has the potential to offer health Can I add probiotics to my diet?
benefits, it shouldn't be called a probiotic Over the years, probiotics have been
until its effects are demonstrated in good consumed in different forms, mostly as
quality studies”. foods and dietary supplements, and are
considered safe for the general population.

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If you are healthy and looking to maintain If you live outside the EU, you should easily
and support your health status, you may find relevant information on the product
want to consider to add probiotics to your label as regulators in different parts of the
daily regime. Moreover, for specific cases, world authorise favourable claims relating
for example when you are given antibiotics, to probiotics and their labelling (e.g.
your doctor or pharmacist may also Canadian guidelines - see annex).
recommend you take a supplement
containing probiotics that can help manage However, for consumers based in the EU,
or reduce the risk for a particular condition things are less straightforward as there is a
(i.e. perturbations induced by antibiotic different approach. There is no EU-wide
courses). People with medical conditions or legal framework defining probiotics nor a
severely weakened immune systems are food category containing probiotics
advised to consult with their doctor before defined. Nor is there a harmonised EU
taking a product containing probiotics. legal framework establishing the conditions
for a strain to be considered as probiotic or
Where to find probiotics a positive list of individual strains which
You can find probiotics in many different have a probiotic status.
forms such as: yoghurt or drinks containing
probiotics available in supermarkets or in
retail food shop or in food supplement form According to the guidelines that IPA
Europe recently published on the use of
in health food shops or pharmacies.
probiotics in food products and
Supplements with probiotics vary from supplements, the word probiotic should
types (i.e. strains of micro-organisms), be used for products provided that
number of live micro-organisms (i.e. certain conditions are met (e.g. being
traditionally used in humans, considered
Colony Forming Units), and form (i.e.
safe for human consumption, viable at
tablets, capsules, sachets). the time of ingestion, containing strains
which are characterised using specified
IPA Europe considers that for any good methods and containing at least 109 live
cells per daily portion).
quality market application, probiotic strains
must be alive in the product throughout The sufficient amount is at least 109 live
shelf life, with at least one billion live cells cells per daily portion to guarantee an
per daily portion18. effect. A different daily dose or quantity
per strain may be sufficient, if it is
backed up by specific studies that have
How to choose the right shown the effects at this doseII.
probiotic
As mentioned above, not all probiotics are
the same as they can have different effects Thus, as a consumer, you cannot easily
and can function in distinct ways. So, how identify which products do contain probiotic
do you identify which products containing strains and which do not. What makes
probiotics are good for you? things even more confusing is an
increasing number of non-food products
doubtfully claiming to contain probiotics

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(i.e. toilet cleaning products, pillows, Finally, do not forget to always verify the
mattresses, cosmetics, etc.). expiration date. This date will only be valid
if the product was stored at the advised
Therefore, as a word of caution, make sure temperature as well. The storage of the
you choose reputable manufacturers as the product at higher temperature will generally
market offers many poor-quality products, reduce its shelf life.
particularly through the internet. Trusted
companies ensure their products with In summary …
reliable quality control or third party testing Hippocrates said more than 2000 years
and conduct relevant research to confirm ago, that “all disease begins in the gut”. As
their products’ effects. Good quality scientists today start to unfold the
products will also guarantee a minimum mysteries behind the complex mechanisms
level of live probiotic micro-organisms at in which our body and health can be
the end of shelf-life. affected by the gut microbiota, it is
becoming clearer (more so now than ever
How to take probiotics before) that a balanced diet that contains
As mentioned above, probiotics are live probiotic food or probiotic supplements, is
micro-organisms. Thus, specific products crucial for our well-being. After all, as the
containing probiotic may be sensitive to saying goes “we are what we eat”!
temperature changes. Therefore, proper
storage is vital.

Products containing probiotic work best

when taken at the right dose and at the right
time. The dose or portion size and
frequency of consumption really depend on
the product and the strain. Follow the
instructions on the packaging to ensure you
receive maximum benefits.

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ANNEX
Regulators in different parts of the world have differing views on claims relating to probiotics
and its labelling I, III, IV.

The Canadian regulatory scheme on probiotics is deemed as one of the most progressive
and well developed schemes globally, allowing probiotics to have health and functional claims
whilst being regulated under the food and/or Natural Health Products (NHP) regulatory
framework. In this regulationI, approved micro-organisms, products, dosage and level of
clinical evidence for different indications are listed. Already in 2009, a guidance was published
by Health Canada, referring to certain strains as probiotics with approved non-strain-specific
claims. This document also explains conditions under which a microorganism can be referred
to as “Probiotic”19. Later in 2015, in the Annex I of the Canadian Probiotic Monograph,
established probiotic bacteria and fungi as well as conditions that must be fulfilled in order to
make the pre-cleared claims are listed. Health Canada also allows any evidence-based claims
for probiotics whether for use as foods or as Natural Health products, which include, structure-
function, disease risk reduction and health claims on a pre-market assessment basis (except
for structure function claims on foods that do not fall under the pre-marketing evaluation
requirement).

In United States, the Food and Drug Administration (FDA) is the main competent agency
regulating these product categories. The FDA has no definition of probiotics and regulates
them based on their “intended use” under the existing regulation.20 With respect to microbial
ingredients, FDA has stated that "bacteria that have never been consumed as food are unlikely
to be dietary ingredients" and instead must be "intentional constituent[s] of food”. Further, FDA
provides the following example; “bacteria that are used to produce fermented foods that are
eaten without a cooking or pasteurization step (e.g. lactic acid bacteria used to produce
cheese or yogurt) could be "dietary substances for use by man to supplement the diet by
increasing the total dietary intake," which are defined as dietary ingredients in section
201(ff)(1)(E) of the FD&C Act (21 U.S.C. 321(ff)(1)(E)). FDA does not have a separate

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regulatory category or definition for dietary ingredients consisting of live or viable
microorganisms21 but such probiotics are within the scope of the food legislation.

In Japan, due to their history and cultural acceptance of such products, probiotics defined as
functional food must comply with the regulatory scheme set out in either of the Japanese
Foods for Special Health Use (FOSHU)22 or Foods with Nutrient Function Claims (FNFC)23.
The FOSHU regulatory scheme is the main legislative framework for probiotics with health
claims and provides for an authorisation procedure by the Ministry of Health, Labour and
Welfare (MHLW), under which functional or physiological health claims are approved24. An
FOSHU claim is subject to a scientific review by MHLW in order to ensure that the food is safe
and efficacious as claimed22.Originally, applications were assessed on an individual basis, but
in 2005, standards and specifications were established for foods with sufficient FOSHU status
and approval on the basis of accumulation of scientific evidence. When an application meets
the established standards and specifications, it will be approved as “Standardised
FUSHUFOSHU”, without being subject to an individual assessment25.The applicant qualifying
under the Standardised FUSHUFOSHU procedure is not required to submit any clinical
efficacy studies, but only safety studies on the product.

In Italy, the use of the word probiotic is allowed for product food and food supplements
providing that certain conditions are met (e.g. being traditionally used in humans, considered
safe for human consumption, viable in the gut, containing strains which are characterised
using specified methods and containing at least 109 live cells of at least one strain of bacteria
per daily serving of the product). However, the use of different amount of live microorganism
may be allowed when its rational has been demonstrated by significant scientific studies
(Ministero della Salute, 2013)III.

Examples of national guidelines on probiotics

I. Guidance Document – The Use of Probiotic Microorganisms in Food - Food Directorate

Health Products and Food Branch, Health Canada, [online]
http://www.hc-sc.gc.ca/fn-an/alt_formats/hpfb-dgpsa/pdf/legislation/probiotics_guidance-
orientation_probiotiques-eng.pdf (2009).
II. New Position Paper on the Use of Probiotics in Food Products & Food Supplements,
[online]
http://ipaeurope.org/images/image/pdf/IPA%20Europe%20Guidelines%20to%20qualify%
20a%20microorganism%20as%20probiotic.pdf (2015).
III. Guidelines on probiotics and prebiotics, Ministero della Salute, Italy, [online]
http://www.salute.gov.it/imgs/C_17_pubblicazioni_1016_ulterioriallegati_ulterioreallegato
_0_alleg.pdf (2013).
IV. Probiotics Guidelines, National Health Service of United Kingdom, [online]
http://www.nhs.uk/Conditions/probiotics/Pages/Introduction.aspx (2016)

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REFERENCES
1. History of probiotics, IPA Europe, [online] http://ipaeurope.org/probiotics.php?ID=2 (2015).
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3. When Bacteria Is a Good Thing: 10 Ways Probiotics and Prebiotics Can Change Your Life, [online]
http://www.alternet.org/personal-health/probiotics-will-change-your-life (2016).
4. Gut Microbiota, European Society for Neurogastroenterology & Motility, [online]
http://www.gutmicrobiotaforhealth.com/en/about-gut-microbiota-info (2016).
5. Gut microbiota, probiotics and their impact throughout the lifespan, [online]
http://ipaeurope.org/images/image/pdf/procedings%20HarvardVF2014.pdf (2014).
6. IPA, [online] A thorough explanation of probiotics & prebiotics
http://internationalprobiotics.online/resources/essentials (2015).
7. Digging into Probiotics: Experts Look at Foods' Bacteria & Health Claims, [online]
http://www.livescience.com/46298-the-lowdown-on-probiotics.html (2014).
8. International Scientific Association for Probiotics and Prebiotics [online]
http://isappscience.org/probiotics/ (2016).
9. Probiotics, European Society for Neurogastroenterology & Motility, [online]
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10. Clinical Guide to Probiotic Products, [online] http://usprobioticguide.com/ (2016).
11. Systematic review: probiotics in the management of lower gastrointestinal symptoms in clinical practice – an
evidence-based international guide, [online] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3925990/ (2013).
12. Evidence-based indications for probiotics in gastroenterology, World Gastroenterology Organisation Global
Guidelines, [online] http://www.worldgastroenterology.org/guidelines/graded-evidence/access-graded-
evidence/probiotics-and-prebiotics-meta-analyses (2017).
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english (2001).
14. Textbook of Aging Skin, Farage, Miranda A., Miller, Kenneth W., Maibach, Howard I. (Eds.), [online]
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research, technological development and demonstration, [online]
http://www.mynewgut.eu/sites/default/files/NewGutLeaflet-update03.pdf (2011).
16. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and
appropriate use of the term probiotic, Colin Hill et all [online] http://ipaeurope.org/images/image/pdf/Hill2014.pdf
(2014).
17. Probiotics, prebiotics and the gut microbiota, ILSI, [online]
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http://ipaeurope.org/images/image/pdf/IPA%20Europe%20Guidelines%20to%20qualify%20a%20microorganism%20
as%20probiotic.pdf (2015).
19. Clinical Guide to Probiotic Supplements Available in Canada, [online]
http://4cau4jsaler1zglkq3wnmje1.wpengine.netdna-cdn.com/wp-content/uploads/2016/01/clincial-guide-canada.pdf
(2016) (there will be an updated version in 2017).
20. Draft guidance for Industry on Complementary and Alternative Medicine Products and their regulation by the Food
and Drug Administration, [online]
http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm145405.pdf (2006).
21. Question IV.C.3. in the FDA guidance on dietary supplements, [online]
https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM515733.p
df (2016).
22. Food for Specified Health Uses (FOSHU), Ministry of Health, Labour and Welfare, [online]
http://www.mhlw.go.jp/english/topics/foodsafety/fhc/02.html
23. Food with Nutrient Function Claims (FNFC), Ministry of Health, Labour and Welfare, [online]
http://www.mhlw.go.jp/english/topics/foodsafety/fhc/01.html
24. Specifications and Standards for Foods, Food Additives, etc. Under the Food Sanitation Act [online]
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Image on Page 6: Courtesy of the International Scientific Association for Probiotics and Prebiotics
©International Scientific Association for Probiotics and Prebiotics (www.isappscience.org), 2016.

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