Probiotics: a trusted strain is a trusted business

By Sophie Bullimore 2-Dec-2019

Clinical trials and working with other sectors on research projects can boost confidence in the efficacy and quality of a strain, says Symprove Chairman Barry Smith

Barry Smith, Chairman and Founder of Symprove

A good business strategy hinges on consumer trust in most products, and probiotics are no exception. Symprove’s Barry Smith has been using probiotics since the 80s, founding a company based on his knowledge in 2002. Now the finished product manufacturer is warning newcomers of the fragility of the essential consumer trust in an increasingly crowded market.

“I think some new companies are at risk of making unsubstantiated claims and unwittingly bringing themselves and the industry into disrepute,” says Smith. “Customer trust is everything and there are a lot of unproven facts and figures used that really undermine this and overall confidence in our industry.”

Smith has a lot to say on some of the traps new companies fall into and how to avoid this dark side of the industry, to instead take advantage of the many opportunities, and it all revolves around confidence in an ingredient.

A strain worthy of pursuing

For Smith, the efficacy of the product and supporting in vitro and in vivo studies are the driving factors for the company to maintain consumer's trust.

The Symprove Chairman recognises that for initial studies into efficacy, many experts advocate for SHIME, the Simulator of the Human Intestinal Microbial Ecosystem. Smith says that this device is important as it is not only non-invasive but can measure so many parameters at once.

SHIME simulates the digestive system so can test the most difficult part of probiotics design; reaching the gut. “It is a huge support for our industry. They are pretty reliable and I believe could also be used to design minimum requirements for the industry for those that are bold enough to be scrutinised,” Smith explains.

Commenting on the product efficacy, Smith says: “For any beneficial bacteria supplement (or probiotic) to be effective, the bacteria must get through to where they can work: the large intestine (or colon). However, this means they must pass through the hostile environment of the stomach and small intestine, which are very acidic (pH 1.5–4). Critically and in contrast to competing products, Symprove does not trigger digestion, hence the bacteria pass through the stomach to reach targeted areas of the gut unharmed, where they flourish.”

New companies are at risk of making unsubstantiated claims and unwittingly bringing themselves and the industry into disrepute

The efficacy is also tested with clinical trials, an evidence-based approach to product development and customer interaction. Consequently, clinical trials have been an important driver of knowledge within the business.

The positive results from research means many universities, nutraceutical companies, and pharma companies are now seriously looking into treatments that use pro/prebiotics. Symprove is one such company partnering with these leading institutions.

Strain by function

The benefits of a healthy, well-balanced microbiome are being increasingly understood, even among the healthy population.

Researchers continue to discover remarkable new links between the gut microbiome and the brain, nervous systems and other areas of the body, meaning that in addition to aiding digestion, probiotics have further uses in the healthy body, such as a means to aid poor sleep, improve memory loss, improve skin condition, boost the immune system and reduce fatigue. There is also a hypothesis that good gut health can have a prophylactic effect, reducing the risk of some infections and preventing overall disease.

Symprove's product

Smith is making sure Symprove is capitalising on this research. “We are already working closely with several leading academics in various fields to explore the importance of gut health in different disease areas. These include Kings College London, UCL and Sheffield Hallam University amongst others,” he says.

Symprove has completed 11 trials, with 11 positive outcomes and several breakthrough results on treatment end-points across a variety of illnesses, with all in vivo trials driven and funded by the clinicians. This groundwork has led the company to initiate more than 15 further trials that are either underway or in the planning stages.

Applications in the pipeline concern conditions such as IBS symptoms in IBD, relief of GI symptoms in Parkinson’s Disease and relief of mucositis and inflammation in paediatric cancer treatment.

“The [trial] that most excites me at the moment is our trial with Sheffield Hallam University, looking at the impact of Symprove on the potential reduction in pain and mucositis in children undergoing chemo and radiotherapy for cancer treatment." As the project is ongoing, Smith can’t say too much at this stage. "The potential to be able to help with some of these symptoms is really rewarding,” he comments.

Quality control

When maintaining consumer trust, the efficacy is just the first line of defence. The next most important factor is that the quality of the final product needs to be kept in check by a stringent set of conditions.

Once the formula is fermented and bacteria added, samples are sent to the company’s GMP partner lab for quality control testing to verify correct bacteria levels and lack of contaminants. The batch is then released for bottling when the COA is confirmed.

QC is all verified by an external GMP-accredited laboratory and complies with all of the relevant health and safety, food safety (FSA and EFSA), labelling and traceability requirements. This external validation is key to consumer trust in any industry, as it provides the user with an unbiased review.

External validation is key to consumer trust

For Symprove’s own facilities, they are all ISO classified, meaning they are kept at a highly clean standard. This is also monitored by a fully outsource independent QA system. The FDA is becoming more involved in supplement production, and these are the kind of measure they are looking to make a norm across the industry.

Symprove has its own, flexible manufacturing facility in the UK, where it has expanded to meet increasing demand, moving from 50k bottles to 120k bottles per month, with the potential to double that capacity again. Smith says: “The key challenge for us is the development and expansion of the production process to meet demand and maintain quality standards. We’ve already invested this year in expanding our production facility and could potentially double capacity again from the same site.”

For Smith, this scalability without compromising quality is a balance all growing companies have to find.

Why probiotics?

There is increasing awareness and scientific support these days of the gut microbiome and the importance of gut health in general – both amongst medical professionals and consumers.

Smith believes that the healthy educated population, as well as those with illnesses, are taking more responsibility for their own health and want to reap the benefits of a well-balanced gut.

For the question of whether to genetically modify strains chemically or stick to natural breeding strains, Smith sits firmly on the side of caution

As a snowballing therapy, Smith believes the next "big thing" in probiotics would be to be able to mix and match both substrates and different bacteria with individualised functions to suit the individual’s needs and the clinician’s advice, creating personalised probiotics. His opinion is right in line with the personalised nutrition trend that the nutraceutical world is currently buzzing with.

Future Trends

There is another potentially divisive topic when it comes to probiotic strains. The question of whether to genetically modify them chemically or stick to natural breeding strains. Smith sits firmly on the side of caution, saying: “I would always go with naturally produced strains. We need to farm them properly and stay in the real world, that’s my gut feeling.”

Another new development that Smith believes is key to future trends is a better-educated consumer. With information becoming more readily available online, Smith says the populace are taking more responsibility for their own health, educating themselves on the benefits of each available treatment or therapy. The vast scientific support backing microbiome influencers may be a large part of their growing popularity. This increasing awareness is not only in consumers but also with medical professionals.

Choosing your approach

Once the strain is chosen, the decision must be made as to live vs freeze-dried delivery. Many may assume that live is fresher and therefore is better. But as Smith explains, the reasoning is in fact far more scientific, looking at the survivability of the bacteria in the hostile environments before the small intestine.

Active bacteria are ready to work on arrival in the body with no delay in activation. However, as actives have to be delivered in a supplement or yoghurt that is recognised by the body as food, digestion is triggered and the product stands a far poorer chance of reaching its destinations. On the other hand, freeze-dried bacteria should reach its destination, but can be sometimes be damaged by the preservation process or take too long to activate, by which point the body has passed it. Each delivery form carries its own risk, and it is up to the manufacturer to decide what is needed for its final product.

Frozen bacteria coming out of storage.
Credit: Symprove

Reflecting on the market as a whole, Smith explains that the probiotic wellness market is relatively crowded, but with a current global value of US$44 billion, there is plenty of room for growth.

To stand out, a company first and foremost needs a product worthy of commercialisation. Once the product’s efficacy and quality have been confirmed, a business strategy needs to capitalise on the many opportunities in this increasing market. Symprove has focused on becoming scalable and trustworthy.

For companies looking to pursue a probiotic angle there are many events on the calendar. Food Matters Live and Probiota are just two examples that cover these industries, which Symprove has attended.

The journey

Symprove has taken a truly organic route into the probiotic world. It was the reduction in mortality within young livestock, and negating the need to use antibiotics, that surprised Smith most when he first introduced a probiotic feed to animals on his farm.

Since then, Smith’s expertise has exploded. He now knows the true value of the microbiome, and in his enthusiasm, he speaks about fellow probiotic enthusiast Bill Gates’ on how they could help solve malnutrition. “I’m really pleased that Bill Gates has recognised this and hope that we can help to become part of the solution,” Smith enthused.

For Smith, the industry is in pole position to make a difference. He explains: “ With a deeper understanding of how the microbiome works and functions in a state of malnutrition, we have a real opportunity now to be able to correct and improve it, so that the body can properly use the nutrition it does get and without long-term negative effects on the microbiome and health in general.”

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For Smith, the industry is in pole position to make a difference. He explains: “ With a deeper understanding of how the microbiome works and functions in a state of malnutrition, we have a real opportunity now to be able to correct and improve it, so that the body can properly use the nutrition it does get and without long-term negative effects on the microbiome and health in general.”