Constipation, indigestion, leaky gut-not subjects easy to talk about, but even less comfortable to actually experience. Digestive health hasn’t been on the top of consumers’ minds in past years, but this has turned around due to the well-documented studies proving that proper digestive function is a prerequisite for overall good health, especially since it is interlinked with the immune system.

According to the National Digestive Diseases Information Clearinghouse (NDDIC), digestive diseases, including irritable bowel syndrome (IBS) and ulcers, affect between 60 and 70 million people in the U.S. As a result, the market for digestive health remedies has expanded in many directions. Stressful lifestyles and poor eating habits have contributed to a number of digestive problems, from occasional indigestion to serious digestive disease.

“The digestive system is essentially the gateway to the rest of the body, so problems in the functioning of this system can lead to repercussions throughout the body,” explained Nena Dockery, technical resources manager, National Enzyme Company (NEC), Forsyth, MO. “Decreases in gastric acid can set up an environment conducive to the proliferation of opportunistic pathogens, such as Helicobacter pylori (a cause of some gastric and duodenal ulcers) or Clostridium difficile (responsible for severe diarrhea). Conversely, an overabundance of gastric acid can lead to gastro esophageal reflux disease (GERD).”

Miguel Freitas, PhD, scientific affairs manager, The Dannon Co., White Plains, NY, added, “Slow intestinal transit has also become a source of true discomfort for a large proportion of the population, the physical and psychological consequences of which should not be underestimated.”

One common result of slow intestinal transit is constipation. According to The Consumer’s Guide to Probiotics by S.K. Dash, PhD, president of UAS Laboratories, Eden Prairie, MN, constipation results in about two million annual visits to the doctor in the U.S. Yet, more people treat themselves without seeking medical help, as proven by the $725 million Americans spend each year on laxatives.

Ms. Dockery also noted that while incomplete digestion of food can cause these minor nuisances, it could also lead to more serious disorders. “If large incompletely digested food molecules are able to pass through the intestinal wall, they can elicit a response from the immune system, which could eventually lead to an autoimmune disorder,” she said. “Inadequate digestion can also prevent important nutrients from being absorbed by the body. There is also some speculation that incomplete digestion of proteins can be a causative factor in the development of some cancers.”

But before companies move forward with their digestive health solutions, Rhonda Witwer, business development manager, Nutrition, National Starch Food Innovation, Bridgewater, NJ, believes the industry must get more specific. “Digestion is such a broad word,” she said. “You have multiple organs, stomach upsets, small intestine issues and large intestine issues, as well as colon problems. And claims like ‘improved digestion’ or ‘maintaining ahealthy digestive tract’ are very polite ways of identifying these problems.”

Ms. Witwer says it’s difficult for someone to differentiate between regularity and a colon issue. That’s why she feels the industry must get more comfortable with the specifics of digestive ailments.

Competing with Pharma

Consumers typically have gone to their physicians to obtain prescriptions for their digestive problems, but with the rise in botanical remedies, dietary ingredients and functional foods on the market claiming to naturally aid in digestion, consumers are now searching supermarket shelves for relief.

“Certainly a product like Dannon’s Activia is an example of consumers’ willingness to accept messages about solutions that aid in maintaining gut health,” said Gregory Miller, PhD, MACN, executive vice president, Science & Innovation, Dairy Management Inc. (DMI)/National Dairy Council, Rosemont, IL. “A few years ago, you wouldn’t have been able talk to consumers about gut health because they didn’t get it or didn’t want to get it. Now we see that they do get it and are open to these messages.”

The problem is trying to keep up with the pharmaceutical companies, which continue to spend large amounts of money to get their messages out to consumers. According to Tom Bohager, president, Enzymedica, Port Charlotte, FL, digestive drugs-prescription and over-the-counter (OTC)-bring in over $12 billion in sales compared to supplement products, which bring in approximately $200 million.

When it comes to consumer education on digestive solutions, Peter Moodie, director, sales and marketing, Enzyme Development Corp., New York, NY, believes the nutraceutical industry can’t compete with the pharmaceutical market. “Talking about what a supplement will specifically do gets into drug claims, limiting how much you can really say to the consumer,” he said. “Drug companies, on the other hand, can make these specific drug claims and therefore take out a full page ad in the newspaper.”

Dr. Kevin Owen, associate director, Nutrition, and Thomas Brancato, business & marketing manager, Nutrition, Lonza Inc., Allendale, NJ, believe the only way to compete with the pharmaceutical companies is to provide effective products backed by convincing science.

Dr. Miller agrees. “It starts with science,” he said. “You’ve got to find good research that can be replicated by clearly delineating how the research was done, what organisms were used and at what levels. We have to fund good science and build consistency there. Then we need to build good communications with the scientific and health professional communities so they fully understand the research and are able to reinforce messages with consumers. Although consumers are getting a lot of their health and nutrition information from newspapers, magazines and the Internet, they are still going to their health professionals for confirmation.”

In the end, NEC’s Ms. Dockery remains optimistic about supplements’ great potential to compete against digestive drugs. “One of the recent trends has been the movement of pharmaceutical digestive aid products to the OTC market,” she commented. “Most of these are acid blockers. Unfortunately, continuously blocking gastric acid can cause problems as well, which are for the most part unaddressed within the pharmaceutical or OTC markets. Digestive enzyme and probiotic products can effectively fill in the gaps left by the pharmaceutical products in restoring or maintaining digestive health.”

Lonza’s Dr. Owen offered a similar perspective. “Many of today’s stomach distress products treat mainly the symptoms (providing short-term relief) and upset the balance of bacteria helpful in the digestive process. Products like Pepzin GI offer gastric sufferers long-term support for maintaining a healthy stomach,” he said.

Essentially, conventional pharmaceuticals and OTC solutions decrease the body’s ability to breakdown foods and getting rid of waste-this is why they are mainly taken for short periods.

Consumers are slowly coming to realize that natural solutions can provide the relief their digestive systems need. While preliminary findings suggest that some Eastern herbal medicines (i.e., Chinese formulas STW 5, STW 5-11 and Tongxi Yaofang, the Tibetan formula Padma Lax, and Indian Ayurvedic herb formulas) may improve gut health, the nutraceuticals industry is in large part focusing on four major categories: probiotics, fiber, resistant starch and enzymes.

Probiotics-The Good Bacteria

While probiotics have long been recognized in Europe and Japan as being essential to good health, they are only just starting to scratch the surface in the U.S. In fact, just a few years ago, if you spoke to American consumers about the prospect of bacteria actually being beneficial, they probably wouldn’t have believed there was such a thing. Thankfully times are changing.

According to Dannon’s Dr. Freitas, specific strains of probiotics can help maintain a healthy balance of essential bacteria in the digestive tract, where about 70% of the immune system is located. In fact, research has shown that certain probiotics help optimize the functioning of the body’s immune system and strengthen its defenses.

“A healthy population of normal bacteria in the gut helps reduce infection and illness risk via multiple mechanisms,” said Tim Gamble, vice president, Sales & Marketing, Nutraceutix, Inc., Redmond, WA. “First, by occupying all available space, normal flora organisms decrease the ability of harmful organisms to ‘move in’ and colonize. Further, they secrete substances, such as acetic and lactic acid, which inhibit growth of less desirable organisms. Gut flora aids in simple digestion and nutrient assimilation and, as has been indicated by research, assists in the synthesizing of a number of vitamins, notably vitamin K, biotin, B12, and other B-complex vitamins.”

The current trend in probiotics is to deliver them in foods and beverages. “Certainly yogurts have been growing in double digits in the last few years,” said DMI’s Dr. Miller. “I think people in the U.S. are finally realizing that probiotics in yogurts are good for them.”

Still, some consumers are left wondering if there is any difference between obtaining their probiotics through supplements or through foods and beverages, and how much they should be getting.

Dr. Bryan Vartabedian, pediatric gastroenterologist at Texas Children’s Hospital, claims the advantage to supplements, if from a reputable source, is that the consumer knows exactly how much bacteria they are getting. But, he said, there is some evidence that probiotics provided in food sources are more effective because the other components in the food help neutralize stomach acid, allowing the living probiotics to make it through the stomach alive.

Current clinical research suggests individuals consume a minimum of one billion colony forming units (CFU) of probiotics daily for digestive benefit, according to Peter Budde, product group manager, Human Health & Nutrition, Chr. Hansen, Inc., Milwaukee, WI. “Although varied by the presence of prebiotics (the food source for probiotics), the majority of clinical support suggests that an individual consume two grams of most prebiotics per day to derive digestive benefit,” he said. A combination of prebiotics with probiotics (also called synbiotics) may also provide a more well-rounded digestive health product.

“It’s also critical for consumers to understand that different strains of probiotics have different effects on certain disease states,” Dr. Vartabedian stated. “For instance, studies show that B. lactis is most effective against IBS, and that L. rhamnosus is helpful in treating diarrhea in children.”

Unfortunately, there are many poor quality probiotic sources on the market. Experts caution that just because a package claims a product contains probiotics, its efficacy may be another story. UAS Labs’ Dr. Dash claims the term probiotic means nothing unless the product contains the right strain(s), in the right amount (potency), in the right condition (viable), in the right formulation and is GRAS (generally recognized as safe).

Research in the area of probiotics has really picked up steam over the last several years. Most recently, Nutraceutix was asked to assist in research aimed at determining whether probiotic ingestion might alter one or more immune markers in a healthy population. It was felt that although a number of past studies showed some promise, these early probiotic supplements did not necessarily deliver the full potential of probiotics.

“Nutraceutix formulated and manufactured a custom probiotic supplement utilizing our BIO-tract technology for the study, which was conducted by a leading health sciences academic center,” said Mr. Gamble. “This study and its results will form the basis for a compelling new product introduction from Nutraceutix before the end of this year.”

Institut Rosell, Toulouse, France, recently released results of a clinical study showing that its Lacidofil formulation effectively reduced the symptoms associated with chronic IBS in patients. The study, conducted by Dr Z. Benes at the Thomayer’s Teaching Hospital, Prague, Czech Republic, is set to be published this month in the journal Nutrafoods.

This study involved 50 patients with a long history of chronic IBS (at least 10 years). Eighty-eight percent of the patients experienced a reduction of IBS-related complaints and most of them voluntarily continued to take the probiotic several months after completing the study.

The researchers concluded that Lacidofil might be a safe and effective alternative for reducing the symptoms associated with IBS. Institute Rosell found the results very encouraging, as most of the patients reported improvement of their condition, including decreased stool frequency and a favorable change in their consistency, improvement of abdominal pressure and pain, dyspeptic complaints, intestinal discomfort and flatulence.

As reported by Dr. Miller, DMI is currently conducting research to see if there are components in milk that have the ability to turn on and turn off certain genes in beneficial bacteria. DMI is also looking at components in milk that may be prebiotic in nature and therefore may help healthy bacteria grow better in the intestinal tract. One component the organization is studying is lactose in order to determine if it is really a prebiotic or a bacteria that should be grown.

Activia is Dannon’s latest product launch into the digestive health arena.

Another important issue in the world of probiotics is health claims. In Europe, there are moves to harmonize legislation related to health food claims, according to Jerry Wells, PhD, MBA, lead of R&D programs in intestinal health at TNO Quality of Life, which is based in the Netherlands. In this vein, he said, “Very specific claims for reduction of disease risk, and even alleviation of common disorders such as constipation, will have to be substantiated by clinical evidence in humans. I think one issue for the probiotic market is that unless the health benefits are scientifically proven and regulated, the term ‘probiotic’ could be used simply to promote many different products.” Ultimately, Dr. Wells added, this could have a negative impact on consumer confidence and hinder the sector’s expansion.

TNO (Netherlands Organization for Applied Scientific Research) sells research and consults to third parties, most of which are industries, in order to help companies test the efficacy and safety of their functional food products, including those for digestive health.

One of TNO’s technologies that resonates very well in this respect is its proprietary in vitro model, which dynamically and accurately simulates digestion in humans. “The type of contract research we do with this model reflects a number of developments that are going on in the U.S. digestive health market,” said Mark Posno, PhD, vice president, business development, TNO Life Sciences Inc. USA, Newton, MA. “Recently we have seen an enormous increase in the work we do with U.S. companies on probiotics, prebiotics and fibers. We are not only looking at changes in the composition of microflora, which you can correlate with beneficial effects, but we are also looking at changes in immune function and tolerance development.”

TNO is also working on testing the anti-inflammatory and immune benefits of probiotics. The tests TNO has developed, according to Dr. Wells, will reveal what factors in food or microbial components are important and provide TNO with insights into their mechanisms of action.

“One of the main challenges in the area of probiotics is to identify biomarkers of health,” said Dr. Wells. “Biomarkers will facilitate human studies and provide a means to quantify health effects and the safety of probiotics in different age groups. At TNO we envision our assays and our validation of those in more complex model systems will actually reveal biomarkers that we can also have tested in humans. These biomarkers can set up a screening system for finding new ingredients or a combination of ingredients that address those biomarkers related to digestive health.”

Finding Unique Fibers

Joe O’Neill, national sales manager, Orafti Active Food Ingredients, Malvern, PA, which is a prebiotic ingredients company, says that the awareness of the importance of fiber in the diet has never been higher, prompting consumers to look for it in different places.

Another company working hard on the fiber front is Cargill Health & Food Technologies, Minneapolis, MN, with its Oliggo-Fiber inulin. According to Pam Stauffer, marketing programs manager, the company is currently working with customers on positioning strategies and co-brand relationships for the launch of new fiber products.

Prebiotic ingredients like inulin have made several appearances in high profile product introductions lately. Products like the new Fiber-Sure supplement from Procter & Gamble, Cincinnati, OH, provide inulin as the fiber source. Just one teaspoon offers 5 grams of soluble fiber, or 20% of the recommended daily intake. Inulin is versatile as a fiber source because it not only provides health benefits, but it also formulates very well in product applications, leaving them completely unaltered with regard to taste and texture.

Orafti continues to study the effects of inulin on all areas of digestive health, as it is a core area in prebiotic research. “Past studies demonstrate the positive effects of inulin on digestive regularity, mineral absorption (increasing calcium absorption), acute illnesses such as stomach upset, diarrhea disease and vomiting, as well as chronic gastrointestinal disease such as colon cancer,” said Mr. O’Neill. “New studies on Crohn’s disease, IBS and the contribution of inulin to feelings of overall health and well-being continue to look promising.”

At the same time the industry is beginning to understand the value of fiber, an ingredient called resistant starch is also making its presence known. This fiber source has a lot of benefits, which is why companies are working hard to provide innovative solutions on this front.

According to National Starch’s Ms. Witwer, natural resistant starch is a prebiotic fiber that is fermented in the large intestine. Because it’s fermented, natural resistant starches have been shown to produce more of the short chain fatty acid butyrate than any other fiber. Short chain fatty acids serve multiple functions that promote health in the large intestine. One function is lowering pH, which helps kill off the bad bacteria.

National Starch Food Innovation claims there are more than 120 published studies demonstrating the company’s Hi-maize 5-in-1 Fiber and Novelose products promote intestinal/colonic health through their action as prebiotic fibers, both of which increase the production of butyrate via fermentation.

“One of the things we are very optimistic about is butyrate, which has been shown to be the preferred energy source for healthy colon cells,” said Ms. Witwer. “There are a number of published studies looking at the impact of butyrate within the large intestine for potential treatment of conditions like colitis, IBS and several intestinal disorders.”

But not all fibers are the same, Ms. Witwer claims. Other fibers, such as soluble fibers that are fermented, may have some related tolerance issues, so people are limited as to how much they can consume based upon the their sensitivity. “We are seeing that people can consume a fair amount of natural resistant starches in their diet without those tolerance issues,” Ms. Witwer said. “Until we get more variety and dramatically improved fiber in the diet, our digestive health problems are going to continue to multiply.”

Essential Enzymes

Over the past three years, Tony Reinsch, territory manager, American Laboratories, Inc., Omaha, NE, has noticed an increase in the use of a combination of enzymes. “American Laboratories Inc. supplies plant, fungal and animal based materials, and each category continues to show that consumers are becoming more aware of the choices and benefits of using these functional materials,” he said.

In the digestive system, enzymes break down or digest proteins, fats and carbohydrates into their simplest components (essential fats, sugars and amino acids). Enzymes also assist in the extraction of vitamins and minerals. The lack of optimal digestive enzyme production can often lead to common digestive complaints.

“The most obvious use of enzymes to overcome a health issue or symptom is to use them to enhance digestion,” said Enzymedica’s Mr. Bohager. “Whether a person has indigestion, heartburn, acid reflux, gas, bloating, fatigue after eating, food cravings and the like, they can benefit from taking enzymes with their meals, which can help make digestion more efficient.

“Either animal or plant-based enzymes may be used; however the plant-based enzymes will provide the most support from a purely digestive approach,” continued Mr. Bohager. “Although if the pancreas is inflamed, sluggish or diseased this is a situation in which animal-based enzymes should be combined with plant-based enzymes as part of a regular regimen. The animal source enzymes will fortify the pancreas, while the plant-based enzymes literally break down the food eaten.”

The gut health market is currently seeing high-potency digestive enzyme blends. “In the last five years, these formulas have increased in potency by at least double,” said Mr. Bohager. And potency happens to be one of the biggest issues with enzymes. “Each enzyme is measured in a lab using an assay to determine how much digestive potential it has in a specific pH and temperature on a specific substrate. Unlike most dietary supplements, these enzymes are not measured by weight in milligrams, rather they are measured using the term ‘active units.’ From a manufacturing perspective, it can be difficult to translate potency to the end user,” Mr. Bohager explained.

As the digestive health market continues to expand, so too does the choice of enzyme products. “Traditionally products marketed for digestive health were formulated for general maintenance and support, or they addressed specific issues, such as lactose intolerance. However the market is definitely branching out,” said NEC’s Ms. Dockery. “There are now products intended for specific dietary regimens, such as high protein diets or sports nutrition.”

NEC has launched new line of digestive health solutions that specifically meet these new consumer needs. BioCore Optimum is a balanced formulation that provides ideal digestive support for persons trying to maintain a healthy lifestyle and eating habits using enzymes specific for all food types. For individuals with diets that contain added macronutrient content, NEC offers BioCore Pro, BioCore Lipo and BioCore Carbo, which provide added digestive support for protein, fat and carbohydrates. BioCore Dairy and BioCore Dairy Ultra are formulated to handle the challenges that some individuals have in properly digesting dairy products. BioCore DPP IV contains DPP IV activity for support in digesting the plant protein component gluten.

This year, NEC has launched three more digestive blends that complement the existing products in the BioCore line. BioCore Kids is a basic digestive formula containing all of the enzymes in BioCore Optimum, but at “kid strength.” BioCore AR was created to support individuals experiencing occasional acid indigestion. In addition to being a broad spectrum digestive formula, this blend also contains calcium carbonate for quick relief from excess gastric acid. Finally, BioCore Edge is the latest product introduction. It contains specialized proteases and was conceived as an adjunct for protein-rich sports drinks and high performance foods containing complex plant proteins.

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Two Digestive Solutions, Two Marketing Approaches

Big marketing campaigns like Dannon’s Activia is helping provide the needed education to consumers on proper digestive health. Prior to its launch in the U.S., Activia yogurt had been successfully introduced in more than 20 countries worldwide.

“We believe that now is the time for Americans to benefit from this clinically-proven product and our initial indication from the success of the product launch confirms that consumers are indeed ready to try and continue purchasing Activia,” said Michael Neuwirth, senior director of public relations, The Dannon Company, White Plains, NY. “We are hearing a lot of ‘thank you’s’ from very satisfied consumers.”

Each 4-oz. serving of Activia yogurt contains billions of beneficial probiotic cultures, including the exclusive Bifidus regularis culture, which is clinically proven to remain live and active in the digestive tract where it exerts its effect.

Since the effects of probiotics are specific to which type and strain of culture used, not all Bifidus probiotic cultures have the same benefit. “Activia is the first and only probiotic yogurt available in the U.S., which is clinically proven to help naturally regulate the digestive system in two weeks when eaten daily as part of a healthy and balanced diet,” said Miguel Freitas, PhD, scientific affairs manager, The Dannon Company. “Activia yogurt works by helping with slow intestinal transit. Studies have shown that Activia can reduce transit up to 40%, depending on levels consumed and the demographic profile. For individuals whose digestive system is functioning regularly, Activia has no adverse effects and provides all the benefits expected of a traditional yogurt.”

Activia is unique in the digestive health arena in that along with providing daily natural regulation of the digestive system, it’s also a great tasting food.

“The launch of Activia is going very well and more than fulfilling our expectations,” said Mr. Neurwirth. “In fact, Activia has built distribution in supermarkets faster than any other product launch in the yogurt category’s history. As of late March -just 10 weeks into the product launch-Activia is already available in approximately 90% of supermarkets nationwide.”

While Dannon’s Activia is taking the market by storm, Reclue Drug Company, Ltd., Vancouver, British Columbia, is going for a more subtle marketing approach with its product of the same name. Reclue is being marketed as an “old world” liquid remedy for fast, prolonged relief of acid indigestion, gaseous distention, loss of appetite, hyperacidity, and/or nervous or sour stomach. But it seems this “old world” medication is also relying on “old world” marketing tactics as well.

Reclue has been available through drug stores in Canada, without prescription, since the mid-1950s. Reclue’s sales success is largely a result of word of mouth-thousands have reported long-lasting stomach relief and continue to testify to the product’s effectiveness. The company strongly believes in the power of their users’ recommendations; of course this is a slow procedure, but the product is still going strong today.

Reclue, a duplication of the an old Norwegian formulation, contains a base of sub-carbonate of bismuth, which when combined with other medicinally approved ingredients, helps to neutralize excess gastric acid while soothing the lining of the stomach, giving an aggravated spot a chance to heal.

Although using two different promotional tactics, both Activia and Reclue have the opportunity to continue to make their mark in a thriving digestive health market.