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Probiotic Promise

AIDP

Research and advancements are setting the stage for even more success in the category.

Still considered in its infancy stage, the probiotics market continues to grow in the double digits. The United States drove global sales of probiotic supplements the past couple years with more than a 20 percent increase in sales. In fact, for digestive health, probiotics are dominating the market, as evidenced by new data.

“We find that retailers and consumers are looking at higher quality probiotic products supported by good science and shelf stability,” said Jay Levy, director of sales with California-based Wakunaga of America. “Expanded areas of research, such as in immune health, are also creating expanded opportunities to create more customized products outside the traditional digestion area. In addition, kids’ nutrition has seen a rapid increase in probiotic attention, as parents try to keep their children healthier.” 

And there’s success outside of the U. S. “Probiotics is still a growing market in almost all regions in the world, in wet formulas, such as dairy products, and in dry forms, such as powders, dietary supplements and functional foods,” said Johan Quintens, director of business development and export department for Belgium-based Vesale Pharma, which partners with Gencor as the exclusive agent for the probiotic technology, Intelicaps. “New markets such as China and Russia are especially growing.”

Advancements 

With this strong growth, the industry is seeing a flurry of research and development (R&D) to address several aspects of probiotic use. “We see more strategies emerging for better protection of probiotics, during the logistical phase (temperature and humidity issues) as well as during digestion (gastric acidity barrier, digestive enzymes, bile, etc.),” said Quintens. “New research makes it increasingly clear that protection of probiotics is necessary to overcome survival issues in both phases.” 

And new technologies are also opening the door for new formulations such as tablets, chewable formulations, oily mixes and combination products with different other nutrients.

That is true for California-based Robinson Pharma Inc. Kenn Israel, the company’s vice president of marketing, said they recently launched a soft gel delivery system for a clinically proven probiotic strain, Unique IS-2, and that they can measure the quantity of probiotic organisms after encapsulation as well as their viability. “We can count them, prove viability, and we have demonstrated that the product is stable,” he explained. “That’s a pretty big advance.” 

There were a number of hurdles that Robinson Pharma had to cross to make it work: “First came measuring probiotics in an oily matrix in a soft gel.Typically, when you washed the carrier oils off of the bugs with a solvent or detergent, you killed them,” he said.This prevented any verifiable claims of viability or stability after encapsulation.

Finding a clinically proven strain that could stand up to the encapsulation process and still provide benefits to humans was another hurdle, Israel added. “Now we’re looking beyond a single strain, and exploring multi-strains and additional strains that can withstand the encapsulation process. This will be another industry first.” Israel noted that the company is manufacturing probiotics in tablet form and developing systems where the compression of the tableting process doesn’t kill the organisms.

Ganeden Biotech, Inc. in Ohio has also invested heavily in R&D as well as clinical research, but is concentrating on building its previous body of work. “We will continue to demonstrate that GanedenBC30 is an extremely safe and effective probiotic that is ideal for products that are not suitable for other nonspore- forming probiotics,” said Michael Bush, vice president of business development.

“One of the latest and most significant advancements in the field has been the move to strain specificity,” he added. “In the past, companies would use data from similar strains to support claims. In reality, different strains within the same species can have very different effects when consumed. For this reason the industry and regulators have been shifting to require data on each individual strain to demonstrate safety and efficacy. Ganeden has conducted dozens of studies on our GanedenBC30 probiotic strain and conducted extensive safety work, which resulted in Ganeden receiving a no objection letter (FDA, GRAS) for the ingredient.” 

As far as formulation, Ganeden continues to expand the uses of probiotics. Companies have the ability to add GanedenBC30 to products such as teas, coffees, sports nutrition products, bars, etc., allowing consumers to get the benefit of the probiotic in products that they consume daily, Bush added.

Jeremy Bartos, PhD and senior innovation scientist with California-based Glanbia Nutritionals, noted that probiotics are also slowly making their way into the sports nutrition and elderly nutrition markets due to new studies supporting the notion that probiotics assist with the breakdown and the absorption of proteins, especially from whey and soy. “The increase in protein absorption may be due to the probiotics’ ability to upregulate the protein kinase C (PKC) activity which increases PepT1-Mediated amino acid absorption,” he explained.“The addition of probiotics to sports nutrition products also allows companies to take advantage of the digestive advantages afforded to people who are sensitive to the side effects of excess protein consumption.” 

Further, the use of spore-forming bacteria is on the rise. “Spore-forming bacteria are sort of like a seed; the bacteria genetic material is encapsulated in a hard shell and only grows in the proper environmental conditions, but instead of needing dirt, water and sunshine like a seed, it needs the perfect temperature and pH of the human digestive system to ‘take root and grow,’” Bartos said, adding that one of the biggest advantages of spore-forming bacteria is their hardiness and shelf stability. “The outer shell acts as a protective barrier to keep the spore viable through the harshest of manufacturing conditions and in products with long shelf lives. Therefore, spore-forming bacteria are not confined to refrigerated products with short shelf lives. Companies are taking advantage of this hardiness benefit by adding them to finished products such as ready to mix protein powders, gummies, encapsulated dietary supplements, cookies, snack bars and even ice pops.”

Bartos noted that individual strains may also be patented, both as a unique strain and for specific uses. “This allows companies to carve out their own niche and protect their assets, something that is difficult to do with natural compounds, especially in terms of owning the actual compound.” 

Pairing probiotics with synergistic combinations is still popular, said Wakunaga’s Levy. The company’s Kyo- Dophilus plus Enzymes finished product contains a synergistic combination of three beneficial human strain probiotics that are critical for a balanced and healthy intestinal function, plus four key digestive enzymes that assist the bodies natural ability to break down proteins, fats, carbohydrates and dairy into absorbable nutritional elements.

Wakunaga’s probiotic for urinary tract health is another example. The combination of Kyo-Dophilus probiotics plus Cran-Max cranberry extract to help maintain a healthy bladder as well as support overall intestinal function and immune support has been a strong seller in the U.S. and internationally, according to Levy.

Stability & Other Challenges 

A problem beyond the lifespan of the probiotic is the accumulation of byproducts caused by normal cellular function. “Probiotics can consume other ingredients in the finished products such as sugars and the resulting byproducts can negatively impact both the flavor and smell of the finished product,” Bartos explained. “Traditional ways around this include refrigeration to slow down bacterial growth, but the use of spore-forming bacteria can also rectify this issue as spores need the proper environmental conditions to begin growing.” 

Another challenge to working with probiotics, according to Bartos, is the cleaning and sterilization processes for equipment once products are manufactured.

Robinson Pharma’s Israel agreed that cleaning up after working with probiotics is something manufacturers would be well advised to think about. “Probiotics can infect a plant; they are live organisms, and I think that this is a grave concern. We spent a considerable amount of time and money creating and validating a cleaning process to assure that when we work with probiotics they wouldn’t contaminate our facility.”

Digestion & More 

Scientific research has shown that probiotics are proving to be beneficial beyond digestion. Along with the aforementioned advantages to protein absorption, probiotics are being used for immunity benefits, Bartos pointed out. “Probiotics help to reduce the growth of pathogenic bacteria in the digestive system by emitting bacteriocins, compounds to discourage their growth in the regions of the digestive tract where the probiotic bacteria reside,” he said. “A high pathogenic bacteria load can present challenges to the immune system. In addition, studies demonstrate that probiotic can also increase T cell production.” 

“The health benefits of probiotics is probably the multibillion dollar question right now,” added Israel. “They are being used to address issues as far ranging as depression and anxiety because they can create neurotransmitters that can cross the brain/blood barrier, regulating blood glucose metabolism, obesity, immune function, inflammatory processes, allergy, athletic performance and the health of many systems in the body, from the nose and mouth, to vagina, feet—you name it.Healthy bacteria colonize every terrain in the body. That said, we need to remember that dietary supplements are not drugs, that our industry isn’t in the disease treatment business, that claims don’t overstep, and assure products are supported by science.” 

And although there is great opportunity to capitalize on these exciting prospects, Israel suggested manufacturers and suppliers approach the category cautiously.

“I think the FDA is asking big questions about this and they are justifiably concerned and thinking about how we regulate this [category]. There’s opportunity for great benefit, but what if people take a wrong species? These are relevant questions that we should ask, like ‘Why do we need to go to super-potent products?’ Probiotics are in foods in the low millions; foods typically don’t have 100 billion. What is the long-term impact of supplementing like that?

“The good news and a convincing argument for the relative safety of the category,” he concluded, “is that people have been exposing themselves unintentionally or intentionally to different organisms for eons and it hasn’t wiped us out yet.” NIE

FORMOREINFORMATION:

■ Ganeden Biotech, (866) 777-0825
■ Gencor, (714) 870-8723
■ Glanbia Nutritionals, (760) 438-0089
■ Robinson Pharma, 714-241-0235
■ Wakunaga of America, (949) 855-2776