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Monday 3RD June 2019


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Enthusiasm for probiotics is really taking off.

It’s partly because people see a connection between them and the human microbiome, the new frontier in medical science.

But there’s probably also a better need to understand some of the issues around them, especially since not all probiotics are the same.

So first, what is a probiotic?

The general definition used by the World Health Organisation is “live microorganisms which when administered in adequate amounts confer a health benefit on the host”1 - but to be labelled a probiotic, scientific evidence for the health benefit would have to be documented.

It’s this “but” that is often overlooked, as many producers of probiotics infer a health benefit, as opposed to establishing evidence on their final formulation.

In many ways, this definition is similar to that of a true biological medicine, defined by European legislation as “a medicine that contains one or more active substances made by or derived from a biological source, such as living cells or organisms”2

Under this definition, biological medicines include “any substance made in the laboratory from a living organism”3 including, for example, vaccines, immunotherapies and stem cells.

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What this implies is that biological medicines go through rigorous clinical evaluation and drug approvals before public availability.

But despite the closeness of definitions of probiotics and biological medicines, in the US there is no scrutiny of probiotics and in Australia it can be similar, with them considered as a food or a listed medicine.

The point is that even though probiotics can constitute a drug like effect, most sold are not clinically validated.

So why do we have this problem?

It has arisen as science explores the human microbiome which is defined by the US National Institute of Health as “the collective genomes of the microbes (composed of bacteria, bacteriophage, fungi, protozoa and viruses) that live inside and on the human body.”4

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It’s important to note the definition includes bacteria, micro-organisms which can be isolated in the lab.

While the human body has a number of different microbiomes, the centre of attention rests with the gut where the work of the probiotic is most known for influencing the microbes within the human gastrointestinal tract, potentially for a positive outcome.

The general public belief is that taking a probiotic will in some way constitute a healthy gut which is associated with improved quality of life, stronger immunity and better secondary organ function.

But as research deepens and as probiotics become more mainstream, it is clearer that not all probiotics behave as previously thought and increasingly there is valid literature questioning efficacy5 and prompting us to reconsider early beliefs.

While I advocate the use of probiotics, I have several caveats:

  • Not all probiotics are the same, which means just one probiotic is unlikely to answer all health needs
  • It’s not about how many strains can be crammed into a bottle but more about the science that tests the entire, complete formulation to validate an outcome
  • Product variability is a huge issue since probiotics consist of live bacteria and not all are grown in identical conditions and formulations, with some containing inactive ingredients to retain quality and shelf life
  • Genuine probiotic work is expensive in maintaining the quality of good strong probiotic formulations and validating end of product shelf life – some probiotics are cheap for a reason
  • I don’t advocate fermented drinks – this is simply because you don’t know what you are consuming

Microbiome research is a rich source for developing probiotics to mitigate disease.

Our own research is showing positive outcomes in treating disease, such as depression.

Overarching Influence Of Probiotics

What we know is that probiotics can do truly remarkable things but research around them is a key difference since they aren’t always the panacea some people think.

Dr Sean Hall

Published 20TH May 2019

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1 - Food and Agriculture Organization and World Health Organization Expert Consultation. Evaluation of health and nutritional properties of powder milk and live lactic acid bacteria. Córdoba, Argentina: Food and Agriculture Organization

2 - European Medicines Agency (2013, May 22). Biosimilar medicines. Retrieved June 17, 2015. From:

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