Probiotics: Under Strain!

Probiotic suppliers hope to capitalize on the creation of more sophisticated products.

Do probiotics have the ability to do it all? To address all key health areas? According to many prebiotic and probiotic experts within the industry, the answer is yes.

If there is one word to define the rapidly increasing pre- and probiotic market, it is “specificity.” The availability of numerous bacterial strains is leading to direct and exciting condition-specific applications, burgeoning the potential market for pre- and probiotics far beyond its roots in digestive and immune support. Consumers are driving demand for these ingredients, and according to Transparency Market Research, the global probiotics market is expected to increase by approximately 6.8% each year through 2018. This amounts to a projected growth from $27.9 billion in 2011 to $44.9 billion in 2018.

Much recent activity in the prebiotic and probiotic realm has been inspired by the Human Microbiome Project, a herculean biological research project initiated by the National Institutes of Health. The aim of the project is, according to its website, “to characterize the microbial communities found at several different sites on the human body, including nasal passages, oral cavities, skin, gastrointestinal tract, and urogenital tract, and to analyze the role of these microbes in human health and disease.”

Understanding the importance of the microbiome in human health has been a major factor in the advancement of probiotic research, says John Deaton, vice president of technology at Deerland Enzymes (Kennesaw, GA). “The microbiome is the collection of all microorganisms that play a role in how the body functions,” says Deaton. “While probiotics are typically associated with digestive health, the microbiome concept demonstrates the importance of these organisms across many different areas and functions of the body, such as immunity and inflammatory response in the ear, nose, and throat.”

Nena Dockery, technical support manager for Stratum Nutrition (St. Charles, MO), and Michael Shahani, chief operating officer for Nebraska Cultures Inc. (Walnut Creek, CA), also point to microbiome research as triggering innovation in strain specificity.

Prior to 2010, Dockery says, there were just a few probiotic manufacturers who emphasized the importance of bacterial strains, and most probiotics were marketed based upon genus and species alone. “Increasingly, more probiotic developers are emphasizing that their unique strains of bacterial species are responsible for health benefits. Without knowing the strain, there is no guarantee of efficacy, but the genomes of most of these novel strains can now be mapped and published.”

This advanced research is also affecting regulations. According to Michael Bush, vice president of business development for Ganeden Biotech (Mayfield Heights, OH), companies previously used data from similar strains to support claims. But different strains within the same species can exert 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,” he says.

Prebiotics, which act as food for probiotics, are also now understood as having important specificities. While the concept of synbiotics-combining pre- and probiotics-is just beginning to have true significance, Dockery says, “We now understand that prebiotics are very selective in the bacteria they feed, leading to a synergic effect with certain combinations of prebiotics and probiotics.”

As one example, Dockery says, an in vitro study was performed on gold and green kiwifruit oligosaccharides to determine their effects on Bifidobacrterium longum.1 According to the authors of the study, gold and green kiwifruit increased counts of Bifidobacterium species by their own unique levels, in addition to selectively influencing colon cancer cells.

In a review of pre-, pro-, and synbiotics, Stig Bengmark of University College London emphasizes that probiotics and prebiotic plant fibers have shown their own particular abilities to influence the immune system.2

The final factor in efficacy is how the beneficial bacteria are delivered to their home sites. Anurag Pande, PhD, vice president of scientific affairs for Sabinsa Corp. (East Windsor, NJ), believes that a critical advancement in prebiotics and probiotics has been in new delivery systems. For example, room temperature-stable Bacillus coagulans strains have allowed for the introduction of various new probiotic delivery systems. Sabinsa’s LactoSpore, for example, has the multi-tasking ability to be incorporated into food-grade products such as breads and yogurts.

Specifics, Specifics!

Suppliers are already commercializing pre- and probiotic ingredients with target applications. And many of these are being evaluated for condition-specific efficacy.

Deerland Enzymes has developed a patent-pending, non-enzymatic prebiotic that Deaton says supports the growth of healthy bacteria in the gut through a mechanism that is not fiber- or starch-based. The product, called PreforPro, is supposed to resolve issues of some conventional prebiotics: it is effective in small doses, within hours; it functions in both the small and large intestines, where it is unaffected by varying gut environments; and it works with a broad spectrum of probiotic species.

Another prebiotic innovation comes from Ingredion Inc. (Westchester, IL), which is currently awaiting publication of a study conducted on its short-chain fructooligosaccharides (scFOS) and an effect on bone turnover markers. “Changes in bone turnover markers suggest a more favorable bone health profile in women supplemented with calcium and scFOS,” says Patrick Luchsinger, Ingredion nutrition marketing manager.

On the probiotic side, there’s no shortage of clinical, condition-specific investigations. Scott Bush, vice president of probiotics marketing at DuPont Nutrition & Health (Madison, WI), says his company has taken an assertive condition-specific approach to probiotic research, not only investigating impact upon digestive and immunity functions, but also efficacy for women’s health, sports performance, infant/toddler/children’s health, metabolic syndrome, and weight management applications. Studies in these areas are in various stages of completion, and expectations are that they should be published within the next six months. “The most interesting development has been research with the strain Bifidobacterium 420,” he says. “It’s been looked at for its impact on metabolic syndrome. We’ve seen encouraging results there. There’s also a phenomenal study that was done in Australia looking at probiotics and sports performance.”

In 2012 Ganeden launched Bonicel, a probiotic-based topical ingredient derived from the fermentation broth of Ganeden’s hallmark probiotic, GanedenBC30. The company recommends Bonicel for anti-aging and skin care products. Clinical trials on the ingredient show that a 5% inclusion rate in products reduces the appearance of fine lines, wrinkles, redness, and under-eye puffiness.

Nebraska Cultures is sponsoring its own human clinical trial, and the company expects the trial to demonstrate how its L. acidophilus DDS-1 probiotic produces lactase and thereby reduces the symptoms of lactose intolerance in humans.

In the realm of immunity, specifically those annoying colds, Pharmachem Laboratories Inc. (Kearny, NJ) offers patented BIFIVIR, what the company deems the first probiotic product with proven efficacy against colds. BIFIVIR combines five probiotic strains (lactobacilli and bifidobacteria) and fructo-oligosaccharides that are specifically selected, since they are preferred by the specific strains in the formula. According to Gregory Bonfilio, Pharmachem director of business development, BIFIVIR was associated with a significant reduction in the quantity and duration of respiratory infections, as well as the intensity of related symptoms, in a placebo-controlled human trial.3

Similarly, Stratum Nutrition’s BLIS K12 and BLIS M18, which Dockery describes as “rare strains of the common species of oral bacteria Streptococcus salivarius,” have been the subjects of recent studies demonstrating potential for supporting upper respiratory health and dental/gum health, respectively. The K12 strain was found to be particularly effective in inhibiting strains of bacteria that are frequently associated with bacterial sore throats (pharyngitis and tonsillitis)4 and middle ear (otitis media)5 infections.

BLIS M18 colonizes around the gum line, and it has been found to present advantages for tooth and gum health. A recently published study demonstrated the M18 strain’s potential for substantial benefits to dental and gingival health.6 “Though preliminary in its results regarding the effectiveness of BLIS M18, this study does provide additional substantiated safety and a trend toward effectiveness as a dental care supplement,” says Dockery comments. “Research in an adult population and with more recent generations of the M18 strain should clearly indicate the protective capabilities of these unique oral bacteria.”

And work continues in prebiotic and probiotic delivery options. New from Sabinsa, as part of its INC (Integrated Nutritional Composite) project, is its synbiotic LactoWise bilayer tablet. It is designed to keep the prebiotic and probiotic components in separate layers until the tablet arrives in the gut.

Also at work on the delivery front is Robinson Pharma Inc. (Santa Ana, CA). In partnership with B&D Nutritional Ingredients Inc. (Vista, CA) and Unique Biotech (Hyderabad, India), the company just launched a Unique IS-2 probiotic softgel, delivering the Unique IS-2 Bacillus coagulans strain in an easy-to-swallow, shelf-stable softgel. According to a Robinson Pharma press release, the strain offers temperature stability, resistant to gastric acids, and survival through transit within the gastro-intestinal tract.

Speaking of the survival of B. coagulans, Nebraska Cultures’ ProDURA, according to Shahani, was tested against other B. coagulans and was found to resist heat over 100° C. The ingredient survived twice as long as other forms in a heat-resistance test, which is critical for food applications where thermal stability is needed.

Prebiotics and probiotics, as well as synbiotics, comprise one of the most intensive nutritional supplement categories. Their innovations, along with the enlightening research findings, will give brand marketers tremendous motivation for new launches and reformulations for a long time to come.

References

1. S Parkar et al., “In vitro utilization of gold and green kiwifruit oligosaccharides by human gut microbial populations,” Plant Foods for Human Nutrition, vol. 67, no. 3 (September 2012): 200–207.
2. S Bengmark, “Integrative medicine and human health-the role of pre-, pro-, and synbiotics,” Clinical and Translational Medicine, vol. 1, no. 6 (May 28, 2012).
3. F Pregliasco et al., “A new chance of preventing Winter diseases by the administration of symbiotic formulations.” Journal of Clinical Gastroenterology, vol. 42 (September 2008): S224–233.
4. F Di Pierro et al., “Preliminary pediatric clinical evaluation of the oral probiotic Streptococcus salivarius K12 in preventing recurrent pharyngitis and/or tonsillitis caused by Streptococcus pyogenes and recurrent acute otitis media,” International Journal of General Medicine, vol. 5 (2012): 991–997.
5. F Di Pierro et al.  “Clinical evaluation of the oral probiotic Streptococcus salivarius K12 in the prevention of recurrent pharyngitis and/or tonsillitis caused by Streptococcus pyogenes in adults,” Expert Opinion on Biological Therapy, vol. 13, no. 3 (March 2013): 339–343.
6. JP Burton et al.,  “Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial,” Journal of Medical Microbiology, vol. 62 (Pt. 6; June 2013): 875–884.