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Probiotics: the evidence and the standards you can expect from Australian  supplements

Probiotics are living microorganisms that boost health when consumed in adequate amounts. There are many different types, and they can be obtained from foods and supplements.



Mounting evidence supports the role of specific probiotic strains in several conditions.


There are ten times more microbial cells living in and on the body1 than body cells. Hundreds of different types of microorganisms and strains interact differently with the gastrointestinal tract and the immune system. More and more research is examining the complex functioning of the human gut flora or microbiome and its effects on mind and body. In fact, the metabolic activities of the gut microbiome are so complex that they have been likened to an organ and some scientists refer to the microbiome as the forgotten organ2.


Widely researched

Probiotics are widely researched for their effects on digestive health and mounting evidence supports the role of specific probiotic strains in several conditions.  These include3:

  • Antibiotic-associated diarrhoea (AAD)

The International Scientific Association for Probiotics and Prebiotics (ISAPP) Board of Directors state: “All hospital formularies should stock at least one appropriately tested probiotic. Further, all physicians should consider recommending appropriately tested probiotics for their patients for whom they prescribe antibiotics”4.

  • Irritable bowel syndrome (IBS)

Many studies show probiotics may help to ease symptoms such as occasional diarrhoea, gas, bloating or distension. The benefits can be meaningful and very helpful to people with such symptoms that severely impact the quality of life5 6.

  • Allergy

The World Allergy Organisation recommends probiotic use for the primary prevention of eczema7.

  • Infant health

Potential benefits of probiotics have been seen for infants with pre-term infant NEC, colic, diarrhoea, and the reduction of antibiotic use8. Of these probiotics, Lactobacillus rhamnosus LGG is one of the most well studied and effective probiotics in children9.


Individual variation

As with any supplement or medicine, diet, lifestyle, health status, genetics and microbiome differences contribute to variations in an individual’s response. Peer-reviewed literature used by reputable academic boards such as ISAPP, and placebo-controlled trials demonstrate clear, clinical benefits for the use of probiotics.

Understanding how the microbiome influences the response to any therapy and how to personalise treatment are exciting areas of research. But this kind of precision medicine does not negate the value of therapies based on randomised, placebo-controlled trials that can show the overall benefit for the group of individuals studied.


Antibiotics and probiotics

There is a significant body of research demonstrating that certain strains of probiotics can assist with the prevention and treatment of antibiotic associated gastrointestinal symptoms, as well as microbiome-related outcomes. However one 2018 study caused some confusion10.

Israel’s Dr Eran Segal found that one probiotic might delay the restoration of gut bacteria in individuals taking antibiotics compared to individuals who took antibiotics alone. Yet a number of challenges may have been identified including that the probiotic was not administered until seven days after treatment, after the damage by the antibiotics had been done.

The study did not track clinical outcomes, and there were potential methodological issues with the microbiome data leading the researchers to these conclusions. Further, the particular probiotic used in the study has no clinical evidence that it assists with antibiotic-associated gastrointestinal symptoms. However, several probiotic strains have been well-studied for clinical benefits alongside antibiotic use11.  

Dozens of human studies with specific probiotics have documented that probiotics help against AAD or C. difficile infection. And in most clinical trials, the probiotic is administered together with the antibiotics.


Safety of probiotics

There are no recognised long term consequences of taking probiotics but it is important to be cautious regarding probiotic use in immunocompromised individuals; it is important to seek the advice of a healthcare practitioner.


Australian standards differentiate Australian products

In Australia, probiotics are regulated as medicines. Claims must comply with the TGA Levels of Evidence Guidelines, evidence likely to be based on strains. The identification and enumeration of the probiotics as per the clinical trial/s is stated.

These pharmaceutical standards differentiate Probiotics in the Australian market versus those in the US Dietary Supplements market for example.

The TGA classifies probiotics as therapeutic goods and Commonwealth legislation applies to all states and territories. The legislation stipulates various Regulations, Therapeutic Goods Orders and Guidelines which companies and manufacturers are obliged to conform to. Probiotics in Australia are produced under the Pharmaceutical model which follows the Pharmaceutical Inspection Conventions Scheme (PICs), an international-based pharmaceutical code of GMP. Dietary Supplements in the USA need to conform to a code of Good Manufacturing Practice (GMP) considered the highest standard of GMP.

References

1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1500832

2 https://www.sciencealert.com/how-many-bacteria-cells-outnumber-human-cells-microbiome-science

3 https://pubmed.ncbi.nlm.nih.gov/32289131/

4 https://isappscience.org/isapp-take-home-points-from-american-gastroenterological-association-guidelines-on-probiotic-use-for-gastrointestinal-disorders/

5 https://pubmed.ncbi.nlm.nih.gov/19622191/

6 https://pubmed.ncbi.nlm.nih.gov/19236549/

7 https://pubmed.ncbi.nlm.nih.gov/25628773/

8 https://academic.oup.com/eurpub/article/29/3/494/5094938).

9 https://onlinelibrary.wiley.com/doi/abs/10.1111/apt.15267

10 https://www.cell.com/cell/pdf/S0092-8674(18)31108-5.pdf

11 https://isappscience.org/clinical-evidence-not-microbiota-outcomes-drive-value-probiotics/


Australia's Complementary Medicines Industry Audit & Trends 2020: Healthy Growth

CMA CEO, Carl Gibson, shares some insights and highlights from our latest audit.

Read the report here.

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