As the late Dr. Bernard Jensen noted, health or illness begins with digestion. With more proof confirming this belief, ingredient suppliers are poised for a growth phase.

What used to be a category largely focused on specific digestive issues, such as con- stipation, bloating and/or diarrhea, is now expanding to include gut health, immune and inflammatory response, metabolic syndrome and the Gut/brain axis. “It will be interesting to see what the future holds for this exciting category,” said Erin Miller, marketing manager with Ohio-based Ganeden Biotech, Inc. 

In fact, the probiotic industry is expected to reach $32 billion by 2015, of which nearly $30 billion will be generated through the sale of functional foods and beverages, with the largest portion being generated by the sale of drinkable and spoonable yogurt, Miller noted.

“There is a great deal of data being generated worldwide regarding digestive health, especially as it relates to probiotics,” she said. “To put it simply, ask four out of five people what health issue usually bothers them the most and they’ll tell you it’s an upset stomach, cramps, gas, bloating, diarrhea, constipation and so on; it’s all related to the digestive system. We hear from consumers every day who routinely suffer from digestive ailments or have a chronic condition like Crohn’s disease or irriTable bowel syndrome (IBS) that affects their quality of life.” 

As a result, global retail sales for digestive health products are the third largest in the health & wellness category, according to a Euromonitor International 2010 IPA Probiotic Update.

Georgia-based Deerland Enzymes, Inc. CEO Scott Ravech said the company has always been focused on a very specialized area of digestive health: enzyme-based supplements. And the company has seen significant growth in recent years. “We surmise that the enzyme side of the digestive health category is growing even faster than the supplement market as a whole,” he said. “Overall, we believe that digestive health has become what some would consider a mega-trend based on the significant increase we are seeing in the number of SKUs our customers have launched and are in the process of developing. Simply put, consumers are clearly recognizing the connection between digestive health and their general well being. In doing so, many are turning to multi component enzyme- based supplements to help support healthier digestion.” 

For this reason, Deerland Enzymes developed and successfully launched new digestive health technologies specifically targeting digestive well being, including Prefix ProTM, ThioZymeTM GI, ThioZymeTM YD (yeast defense) and two recent product launches, GlutalyticTM and DiarylyticTM.

Prevalence of Digestive Issues 

Diet and stress seem to be the main cause of increasing digestive distress, according to Gregory Bonfilio, director of business development with New Jersey-based Pharmachem Labs.“Health status is often attributed to and affected by diet, and diet is processed by the digestive system. Equally, stress affects digestion and absorption, and depending upon the individual, can result in diarrhea or constipation, nausea, decreased appetite or increased appetite.

“There’s a compelling school of thought that we are not ‘biological machines,’ but more like fermentation factories,” he continued. “The more Effectively we ferment what we put into our bodies—and the higher quality the media we use—then the better health we will achieve. If this digestive system, or ‘fermentation tank,’ is sub par, all other systems suffer.” 

Dr. Ralf Jäger, FISSN, CISSN, a member of the American Gastroenterological Association (AGA), and scientific advisor with Pharmachem Labs, agreed. “Our fast-paced, on-the-go society results often in wrong food choices and the first problem of digestion starts with what we put in our mouths,” he said.“In addition, we are simply eating too fast. Digestion actually starts in your mouth and we should really slow down and chew our food thoroughly, at least 20 chews per bite. Your stomach will appreciate the work of your digestive enzymes in your mouth. However, the key to your digestive health lays a little further down your digestive tract in the small intestine. Good bacteria, probiotics, aid digestive regularity and sup- port your immune system.” 

Jäger pointed out that probiotics have been linked to reduce the incidence of allergies in infants. In an attempt to prevent celiac disease, parents in Sweden were asked to delay the Introduction of gluten until the babies were 6 months old. Unfortunately, after six months many Swedish mothers stopped breastfeeding their children, taking away the natural source of bifidobacteria. Introducing gluten without the protection of the probiotic resulted in tripling the incidents of celiac disease. “Every day we are learning more about the beneficial effects of probiotics and have to date only scratched the surface of the potential benefits of those friendly bugs,” he said.

Ingredients & Consumers 

When asked about some of the best ingredient choices, Ganeden Biotech’s Miller pointed out that there is a worldwide ingredients industry focused on digestive health. “Many consumers immediately think of fiber and probiotics when they are considering ingredients to support digestive health.CPG companies have done a great job including fiber and are now turning to probiotics to provide digestive health benefits to their products,” she said.

“We’re seeing a tipping point here as more consumers become aware of natural ways to support digestive health and are looking for products to give them the support they desire without resorting to the use of pharmaceutical drugs,” Miller said, adding that probiotic consumers are really anyone looking to live a healthy lifestyle—moms on-the-go, fitness enthusiasts, the aging population and even the family pet.

As purveyors of probiotics, Pharmachem Labs said the wide variety of targeted microflora is critical in restoring and maintaining healthy digestion. “We can thank the makers of Activia and similar probiotic-containing products for making ‘probiotics’ a much more widely recognized category; where consumers do feel they need it to achieve ‘balance,’” said Bonfilio.“Many of these commercials are targeted toward women, because women tend to be earlier adopters of supplements than men.” 

Product Offerings 

Pharmachem Labs has put forth Bifidobacterium breve BR 03 (DSM 16604), which offers the key structure/function attributes of microflora balance, intestinal transit and intestinal comfort.1 The company also produces Lactobacillus acidophilus LA 02 (DSM 21717). This product’s key structure/function attribute is intestinal comfort.2 

Meanwhile, Ganeden Biotech offers a patented probiotic strain marketed as GanedenBC30 (Bacillus coagulans GBI-30, 6086). “GanedenBC30 is unique because inside each cell is a hardened structure, or spore, which is similar to a seed,” explained Miller. “This spore serves as a natural protective shield against the heat and pressure of manufacturing and the strong acids in the stomach to arrive alive and then thrive in the intestines—their intended target. Other traditional probiotic bacteria, such as lactobacillus, acidophilus and bifidobacteria, are not able to form these protective spores, making them more vulnerable to manufacturing processes and stomach acid.Gane-denBC30 is designed by nature to survive and thrive so more probiotic cells can help support your digestive and immune health.”

GanedenBC30 is highly acid tolerant and grows well in the gut to provide digestive support through the metabolism of a variety of substrates. It also produces lactic acid, which in turn helps to lower gut pH, thus providing an environment that is more conducive to the growth of good bacteria versus bad.

“As this is a living organism, the organism itself has not changed, but the formats continue to evolve to meet the demands of our partners,” Miller explained.

And then there’s Lallemand Health Solutions in Montreal, Canada, which offers a range of digestive health products that address the whole digestive tract, including:

• For the stomach, Gastro-AD® is a food supplement based on non-GMO soy fermented by proprietary strain Lactobacillus delbrueckii Rosell-187, recommended for gastric comfort and relief of occasional heartburn. Gastro- AD represents a natural and safe alternative to heart-burn management products, with the extra nutritional benefits and healthy image of fermented soy. Gastro-AD has been tested in several clinical trials, in almost 600 subjects in total: it was shown to be very well tolerated and led to a quick relief of ulcer symptoms including heartburn, pain, vomiting and constipation.

• For the gut, the Company offers a line of probiotic strains and ready-made formulas to address microflora balance and specific disorders, such as antibiotic-associated diarrhea prevention, acute gastroenteritis in children, management of IBS symptoms, lactose intolerance, traveler’s diarrhea and overall digestive comfort and microflora balance.

“Probiotics are living organisms and their benefits are linked to their biological activity and interactions with the host microflora, an extremely complex and organized ecosystem,” explained Isabelle Champie, global marketing director with Lallemand Health Solutions. “So there are several possible modes of action for probiotics, depending on the condition or the strain used and we are just beginning to understand some of these and we certainly have a lot to discover still.

“Concerning the most documented modes of action,” she added, “let’s say that it has now been clearly established that probiotics help normalize and maintain the balance of the intestinal flora through the production of substances that inhibit the growth of pathogenic bacteria (e.g. lactic acid), and inhibit the adhesion of pathogenic bacteria to the intestinal wall (by competitive exclusion) as well as the competition with pathogenic bacteria for nutrients.” 

A recent achievement for the company’s probiotics is that they have gained condition-specific health claims in Canada:

• Protecflor®: “Helps to reduce the risk of traveler’s diarrhea” (Claim NPN 80021342).

• Lacidofil®: “Restoring and maintaining intestinal flora” and “Helps to reduce the risk of antibiotic associated diarrhea AAD (in children and adolescents from 2 to 18 years of age)” (Claim NPN 80020017).

• Lalflor® (sachets or capsules) (Saccharomyces cerevisiae Boulardii CNCM I-1079): “Helps to reduce the risk of antibiotic associated diarrhea”

At Deerland Enzymes, depending on the product technology, the company has focused on probiotics and prebiotics along with enzymes. “Products containing probiotics have gained significant ground in popularity in both the functional foods/drinks and supplement markets,” said Ravech. “In addition, research has shown that there are certain prebiotics that can increase the benefits of probiotics; however, these fiber-based prebiotics often come along with several draw- backs.” 

In response to this challenge, Deerland Enzymes’ research and development team recently introduced a prebiotic that is not fiber- or starch- based, is effective in small doses (15 mg) and does not exhibit any of the drawbacks of more commonly used prebiotics. This patent-pending product, called PrefixPro, is backed by both in-vitro and in-vivo studies that demonstrate its superiority to the typical prebiotics that have been used to date.

In addition, a proactive initiative by Deerland Enzyme’s research and development team has been to expand beyond the traditional enzyme blends (whether a single or multi-enzyme) to include other ingredients that enhance the efficacy of the supplement, Ravech explained. As a result of the company’s joint product development alliance with health care technology company Thione International, Deerland Enzymes is combining enzymes with other natural ingredients, such as pep- tides, essential oils, and chelators. “Our ThioZymeGI and ThioZymeYD products were born from this research, and these formulations are on the cutting edge of digestive health supplement technology,” Ravech said.

Delivery Formats 

Guarding digestive health demands products make the “right moves.” “Survival of probiotics during the gastroduodenal transit is crucial to maximize the potential health benefits of the strains,” said Pharmachem’s Jäger, noting that the company and its partners have developed a patented microencapsulation technology, clinically proven to increase the colonization of good bacteria five-fold compared to the same strains in an uncoated form.“The use of a five-times-lower amount results in cost savings for the manufacturer and the consumer. It increases Shelf life while eliminating the need for refrigeration, and enables the development for unique delivery forms and even foods.”3 

For enzyme-based supplements, capsules are by far the most common delivery method, according to Ravech.“Tablets are also used, but with far less frequency. This is driven by both consumer preference (ease of swallowing), and by the nature of enzymes—when tablets are compressed, it generates heat and pressure necessitating the addition of an enzyme ‘overage’ to compensate for any activity (potency) loss.” For enzymes that may be more sensitive to the gastric acid environment of the stomach, Deerland Enzymes offers three options to address this concern:

• Enteric coated capsules and tablets—This coating provides the greatest degree of protection by far, but typically adds considerable lead- time and cost to the finished product, according to Ravech.

• Delayed-release capsules—These can provide protection for up to 30 minutes.

• SerratericTM—A novel gastric protection system developed by Deerland Enzymes, which may be a viable alternative for acid sensitive ingredients,Such as serra tiopeptidase.

Other Considerations 

Ravech noted that food intolerances and food driven immune reactions are becoming more recognized by consumers, and added that complete digestion of substances that cause the intolerance or immune system reaction help to minimize potential problems. “Gluten and dairy intolerances are especially good candidates for an enzyme-based solution,” he said. “Another growing trend for consumers is an interest in Muscle health, both improvements in muscle tone and maintenance of muscle as we age. Many are consuming protein supplements in an effort to support muscle. Some individuals have difficulty breaking down the whey protein contained in supplements, which creates a demand for products that support protein hydrolysis.” 

Ganeden Biotech’s Miller concluded that the causes of these widespread digestive issues can range from inflammatory bowel diseases and food allergies to overuse of antibiotics and hand sanitizers. “Regardless of the cause, we do not anticipate a decrease in the incidences of digestive issues in the near future.” NIE

References: 

1 Del Piano M. et al., The use of probiotics in the treatment of constipation in the elderly. CIBUS, 2005; 1(1): 23-30.

2 Saggioro A., Probiotics in the treatment of Irritable Bowel Syndrome. J Clin Gastroenterology, 2004 Jul; 38(8): S104-106.

3 Del Piano M, et al: “Evaluation of the Intestinal Colonization by Microencapsulated Probiotic Bacteria in Comparison With the Same Uncoated Strains.” J Clin Gastroenterology, 2010, 44(1):S42-S46.

“Probiotics are living organisms and their benefits are linked to their biological activity and interactions with the host microflora, an extremely complex and organized ecosystem.”

“Overall, we believe that digestive health has become what some would consider a mega- trend based on the significant increase we are seeing in the number of SKUs our customers have launched and are in the process of developing.”