This year pharma began to turn its eye towards the power of the microbiome

It has been a big year for the microbiome: significant data published, strong media debate, product pipelines developing and significant investment. With this comes a feeling of hope that the answer to many health questions lies within the complex interaction of bacteria that we play host to. The microbiome and probiotics are not new, but it has been a year of increased understanding of how we feed our microbiomes, and potentially a catalyst for treating more health conditions in 2019.

Politics and the microbiome

Back in May, the Parliamentary Office of Science and Technology (POST) published its view on confirming importance of the microbiome in disease management and the evidence behind interventions, such as probiotics. This is a clear indication that we can expect to see regulators, like the MHRA, recognise probiotics and their potential use within the NHS.

A notable focus was the prevention and management of conditions in the public’s interest, including: C. difficile infection, IBD and obesity. There remains though some conflicting advice, with Public Health England giving guidance to CCGs that “probiotics should not be routinely prescribed in primary care due to limited evidence of clinical effectiveness”.
Celebration and discovery

27 June marked the first World Microbiome Day – encouraging public dialogue on the critical importance of microbiomes to human, animal and environmental health. With 95% of our microbiota residing in the GI tract and outweighing the human genome 150:1, it is not surprising to see an explosion in research linking the microbiome to health conditions, including: cardiovascular disease – arterial hardening; ageing through inflammation; organ transplant rejection; Parkinson’s disease and stroke; and obesity.

Interest and areas of study are bound to expand as experts race to map the microbiome; particularly the phylum of bacteria, the species and their relative and absolute importance. Whilst mapping the human genome was one of the great feats of the 21st century, we now know that 90% of genes serve no known function. One of the challenges for microbiome research, at least for now, is to show the specific activity of bacteria and their interactions.

The good, the bad and the live

In the second half of the year published opinions led to the suggestion that probiotics don’t work – bacteria within them are transient at best. Looking at the overall body of evidence ‘most’ don’t. We’re at a turning point in redefining what probiotics are. Simply finding ‘good’ bacteria and squeezing them into a pill or yoghurt might not be the best approach, it is the combination of the right bacteria and an effective delivery system that is product specific which can deliver the promise that probiotics hold.

Since 2002 the World Health Organization has defined probiotics as “live microorganisms which when administered in adequate amounts confer a health benefit on the host”.

This has led much recent research to provide evidence that, with an effective delivery system, live and active bacteria can not only survive stomach acid but go on to colonise the luminal and mucosal parts of the proximal and distal colon. Everybody has a microbiome and in many cases, it’s not about introducing new bacteria, it’s about supporting the existing bacteria in the biome that already live there – researchers from UCL have even suggested we can make the healthy healthier, and that ‘rebalancing’ the microbiome and supporting the existing microbiota may in fact have a positive immunomodulatory effect.

The year ahead is certainly competitive, with progressing pipelines and the presentation of new data. But there will be need to re-balance the regulatory environments, not just our microbiomes – to allow wider application of proven products and explore their use in promising research avenues. There are a 100 trillion good reasons to understand the microbiome – and to allow this existing science the opportunity to flourish.

Mike Butler is CEO of Symprove