PROFESSIONAL FORMULATION ProBiotic & ProBiotic Multi ProBiotic (V-PB) 25 Billion C.F.U/gram 90 capsules per bottle Non-Dairy ProBiotic Multi (V-PBM) 15 Billion C.F.U./gram 45 capsules per bottle Non-Dairy Probiotics: A Common Sense Discussion Overview Probiotics are most simply defined as naturally occurring health-enhancing micro-organisms consumed as a food component or dietary supplement. Other common terms for probiotics are friendly or healthy bacteria. How do Probiotics Work? To understand how probiotics work, it is important to know a little about the microbiology of the human body. Humans, like animals, are highly colonized microbes. Microbes live on our skin, in our mouths, in Figure 1 women s vaginal tract and throughout our gastrointestinal (GI) tract (Figure 1). It is estimated that there are 1,014 microbes associated with our bodies. That is 10 times greater than the total number of cells our bodies contain. For centuries people have knowingly consumed probiotics as a natural component of their food supply. Fermented milks have historically been the most common foods containing probiotics. However it was not until 1908, when Elie Metchnikoff published his book entitled The Elongation of Life that health benefits were first attributed to the consumption Since probiotics are consumed as food and of milk fermented with specific types of bacteria. dietary supplements, it is also helpful to review some basic information on the human digestive Bacteria promoted as probiotics should have system. The digestive process begins as soon as an established history of safe use and food enters the mouth. The process of chewing documentation of efficacy. They should be increases the surface area of food particles, normal inhabitants of the human body. making the food more susceptible to the digestive Delivery in an effective dose, with viability enzymes, including those in saliva. Smaller guaranteed through shelf life under food particles also travel more easily (and recommended storage conditions, is critical. A therefore more quickly) through the GI tract. minimum dose of billions of probiotic bacteria In the stomach food is mixed with gastric juice, per day is generally regarded as necessary to containing digestive enzymes and hydrochloric observe health benefits. Storage under refrigerated acid. This mixture, known as chyme, is then conditions is recommended to assure viability. actively pumped out of the stomach and into
the small intestine. There more enzymes and bile are mixed with chyme, and the breakdown of dietary proteins, fats, and carbohydrates is completed. Most nutrients are absorbed in the small intestine. Within about 4-6 hours of eating, what is left of the food passes into the large intestine, or colon. Waste material accumulates, water and electrolytes are absorbed and fecal matter is stored until it passes out through the rectum every 24-48 hours. Gastrointestinal Tract Microbes are not very prevalent in the small intestine. The high acid and bile concentrations coupled with the rapid transit time of contents is not favorable to microbial growth. However, toward the lower small intestine, microbes begin to attain higher populations (106-108/gram of small intestine contents) and in the colon they constituate Figure 2 about 1,011-1,012/gram of colon contents. This is a huge number of microbes. Considering the multitude of microbes in the intestinal tract, what are the effects of their presence? It is known that microbes in the large intestine complete the digestion process on any food components that were not digested in the small intestine, such as lactose in lactose intolerant people or soluble fibers which are resistant to enzyme present in the small intestine. But there is evidence of non-digestive microbial activity as well. Certain intestinal microbes are known to produce vitamins. Also, in studies done with special microbe-free laboratory animals, evidence is strong that without normal microbial populations, the immune system functions poorly, and resistance to pathogenic bacteria is greatly reduced. Other evidence suggests that intestinal microbes might act as mutagenic compounds. Depending on the specific microbe, mutagenic activity can either be increased of decreased. Health Effects Of Probiotics Using probiotic cultures to promote health has an inherent advantage in that it is a natural approach... There are hundreds of papers published on many health benefits of probiotic cultures. Described in these publications are in vitro studies, studies in animal models and human clinical studies, all designed to determine how probiotic cultures may influence a variety of health conditions. Of course, these are very complicated questions, and research is still actively being conducted to further define the role of probiotics in human health. But what can be said is that an evaluation of the body of research done on probiotic cultures suggests that certain strains consumed at high levels positively influence human health. Food sources of probiotics, like milk and yogurt can be healthy additions, but due to intolerance and lower culture levels, supplementation becomes a more viable option. Using probiotic cultures to promote health has an inherent advantage in that it is a natural approach which does not disturb the natural colonizing flora of the human body. Perhaps the most compelling use of probiotic cultures is to decrease the degree of disturbance of the normal intestinal microflora which comes with antibiotic use. The purpose of antibiotics is to kill harmful bacteria. Unfortunantly, they kill normal bacteria also. Instead of wiping out bacteria, probiotics promote growth of friendly flora, which in turn fight disease and infectious-causing bacteria. The following describes some of the further proposed health benefits of consumption of probiotic cultures. Immune System Stimulation The immune system provides an important defense against microbial pathogens which have entered our bodies. The immune system is extremely complex, involving both cell-based and anti-body based responses to potential infectious agents. Immunodeficiency can result from certain diseases (e.g. cancer, AIDS, leukemia) or to a lesser extent from more normal conditions such as old age, pregnancy, or stress. Autoimmune diseases (e.g. allergies, rheumatoid arthritis) can also occur due to misdirected immune system activity. How are our Gut and Immune System Related? The gastrointestinal tract is the primary interface between us and our outside environment. The total mucosal surface area of the adult GI tract is about 300 square meters, and is by far the largest body area exposed to foreign substances like pathogens, harmless bacteria and food. The gut-associated lymphoid tissue (GALT) makes the GI tract our largest 2
immune organ. It is through this mechanism that probiotics are thought to influence the immune response. Probiotic cultures have been shown in a variety of test systems to stimulate certain cellular and antibody functions of the immune system. Animal and some human studies have shown an effect of yogurt or probiotic bacteria on enhancing levels of certain immunoreactive cells ( e.g. macrophages, lymphocytes) or factors (e.g. immunoglobulins, interferon). In addition, some studies have shown improved survival of pathogen-infected laboratory animals consuming probiotic cultures as compared to animals consuming a control diet. Results accumulated so far suggest that when ingested, probiotics organisms are exposed to the mucosal layer of the GI tract, providing an additional tool to help your body protect itself. Hypertension About 50-60 million people in the United States are estimated to have hypertension, or elevated blood pressure. Evidence suggests that some decrease in blood pressure may result from the consumption of lactobacilli. Some studies done with hypertensive rats have shown a positive effect. Studies with human subjects are limited. However, one study conducted with subjects with hypertension showed a decrease of 10-20mm Hg in systolic pressure. Attempts to isolate the component implies that the cells need not be alive to mediate this effect. Other research demonstrated that a compound produced when probiotic bacteria were grown caused an anti-hypertensive effect. These results suggest that consumption of certain lactobacilli, or products made from them, may reduce blood pressure in hypertensive subjects, providing patients another tool in managing elevated blood pressure. Vaginitis The vagina and its microflora form a finely balanced ecosystem. Disruption of this ecosystem can lead to a microbiological imbalance and symptoms of vaginitis. Vaginitis used to be considered a mere annoyance, but now is being examined for a role in serious conditions including pelvic inflammatory disease, pregnancy related complications (e.g. low birth rate babies) and increased susceptibility to AIDS infection. Vaginitis can be caused by several different organisms, and in many cases, the causative agent may not be identified. What is known is that lactobacilli predominate in the healthy vagina, and a lack of lactobacilli (especially those producing hydrogen peroxide) is correlated to vaginitis. The lactobacilli are thought to maintain a favorable vaginal ph in the acidic range and to inhibit pathogens via the production of hydrogen peroxide. Intravaginal applications of lactobacilli have been shown somewhat effective in treating bacterial vaginitis. One study done with 13 women showed that consumption of Lactobacillus acidophilus decreased the incidence and duration of vaginal infections. Diarrhea Many types of diarrheal illnesses, with many different causes, exist. These can result in bacterial imbalance, leading to diarrhea. Replenishing the flora with normal bacteria during and after antibiotic use can improve the microbial balance until the normal flora is reestablished. Probiotics have also been tested for effectiveness against Clostridium difficile colitis. In general, the results suggest that consumption of high levels of a quality probiotic may shorten the duration or decrease the incidence of certain diarrheal illnesses. Small Bowel Bacterial Overgrowth Under certain conditions, such as production of low stomach acid or in patients with kidney disease, microbial populations in the small intestine can increase significantly beyond normal levels. This is termed small bowel bacterial overgrowth. The high population of these microbes can produce by-products from their growth, which can be toxic. Researchers have found that feeding high levels of Lactobacillus acidophilus can control the toxic effects of these microbes. This is another example of the ability of probiotic strains fed in high numbers to modulate the activity of other intestinal bacteria. Lactose Intolerance The inability of adults to digest lactose, or milk sugar, is prevalent worldwide. People of northern Europe descent are unique in retaining the ability to produce the lactose digesting enzyme, lactase, into adulthood. Consumption of lactose by those lacking adequate levels of lactase can result in symptoms of diarrhea, bloating and flatulence. These symptoms are due to the undigested lactose reaching the large intestine and being fermented by the colonic microbes. These microbes can produce gases and products which lead to watery stool. 3
The approach to coping with lactose digestion problems can be multifaceted, including moderating intake of dairy products, ingesting lactase prior to eating dairy products, and consumption of products containing pre-digested lactose. Many consumers have also noticed that they are better able to consume fermented dairy products, such as yogurt, with fewer symptoms that the same amount of unfermented milk, even though yogurt contains about the same amount of lactose as milk. Yogurt was found to aid digestion of lactose because the lactic acid bacteria used to make yogurt produce lactase and digest the lactose before it reaches the colon. In addition to yogurt starter bacteria, Lactobacillus acidophilus and bifidobacteria have been shown to improve digestion of lactose. Elevated Blood Cholesterol Cholesterol is essential for many functions in the human body. It acts as a precursor to certain hormones and vitamins and it is a component of cell membranes and nerve cells. However, elevated levels of total blood cholesterol or other blood lipids are considered risk factors for developing coronary heart disease. Although humans synthesize cholesterol to maintain minimum levels for biological functioning, diet also is known to play a role in maintenance of serum cholesterol levels, although the extent of influence varies significantly from person to person. Probiotic cultures have been evaluated for their effect on serum cholesterol levels. Although clinical studies on the effect of lowering of cholesterol or low density lipid levels in humans have not been conclusive, there have been human studies which suggest that consumption of probiotic-containing dairy foods in people with elevated blood cholesterol can reduce this level. Various Studies have shown that healthy bacteria may improve our well-being via: Manufacture and assimilation of B vitamins. Enhancement of dairy product digestion. Reduction of serum cholesterol levels. Improvement in digestive and bowel functions. Stimulation of the immune system. Reduction in antibiotic side effects Exclusion of harmful microbes associated with diarrhea, yeast infections, urinary tract infections, and small bowel bacterial overgrowth. Binding of mutagens by cell wall components (in vitro) Reduction of lactose intolerance Vinco s ProBiotic and ProBiotic Multi Factors of Stability Figure 3 Located throughout the digestive tract, Lactobacillae are especially abundant in the small intestine. Some of the main human varieties are: Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus brevis and Lactobacillus salivarius. By nature of the cultures, the choices of strains and carriers, manufacturing procedures, handling of materials and storage are all critical to the viability of the end product. We start by using culture strains that have the most recognized history of beneficial use - Lactobacillus (Figure 3) and Bifodobacterium (Figure 4). We can not justify the use of less potent strains, and certainly not use those which, although retaining activity, are not beneficial to human gut terrain, like Faecium. Figure 4 Located in the entire digestive tract, Bifidobacteria are especially abundant in the large intestine. The system's first inhabitants, these species evolve according to age, diminishing progressively towards the end of life. Some of the main varieties are: Bifidobacterium breve, Bifidobacterium infantis and Bifidobacterium longum in children, and Bifidobacterium bifidum and Bifidobacterium longum in adults. We have incorporated a proprietary process of stabilization to protect the culture cell walls. We then chose to use a patented Microcrystalline Cellulose carrier to make the effects of moisture as negligible as possible on our culture. Ask us for copies of our stability study in which we compared the properties of five different carriers. It is interesting to see how the life expectancy of the same cultures can vary with different carriers. This effect was consistent over different temperature ranges as well. We require controlled environments in the production of raw materials and encapsulation, ensuring that the active culture levels will remain viable. This control is not only to safeguard against moisture levels, but temperature as well. The cooler the better is still the rule. There has been a lot written about new technologies that allow products to retail their activity at room temperature. While there might be evidence to support further research in this technology, the end result is not a reality today. Even if there were to wrap an impenetrable shield around these cultures, making it impossible for moisture to effect them in any way, they would still be 4
damaged by the heat of sitting on the shelf. One other manufacturing decision was to guarantee label claim. While other companies publish C.F.U. numbers on their labels that relate to the amount of culture at the time of manufacturing, the label claim of 25 Billion C.F.U./gram for Vinco s ProBiotic and 15 Billion C.F.U./gram for Vinco s ProBiotic Multi is what our customers should expect to see through the life of the product. With choice of strains, carrier, bottle type, stability testing and proper handling, we have gone a long way to ensure that at the time of last dosage, our product should still beat label claim. Vinco s ProBiotic 90 Capsules 25 Billion C.F.U./gram S upplement Facts Serving Size: 2 Capsules (1 Gram) Servings per Container: 45 Amount per % DV* Serving Total ProBiotics 25 billion CFU/Gram ** (from Lactobacillus Acidophilus 12.5 billion, and Bifidobacterium Infantis 12.5 billion) In a base of: Microcrystalline Cellulose and Fructo-Oligosaccharides (FOS). *Daily Value (DV) not established DV is based on a 2,000 calorie diet. ** Not currently considered essential. Vinco s ProBiotic Multi 45 Capsules 15 Billion C.F.U./gram S upplement Facts Serving Size: 2 Capsules (1 Gram) Servings per Container: 22.5 Amount per % DV* Serving Lactobacillus Acidophilus 3.5 Billion CFU * Bifidobacterium Infantis 3.5 Billlion CFU * Lactobacillus Plantarium 2 Billion CFU * Lactobacillus Rhamnosis 2 Billion CFU * Bifidobacterium Breve 2 Billion CFU * Bifidobacterium Longum 2 Billlion CFU * *Daily Value (DV) not established DV is based on a 2,000 calorie diet. Other Ingredients: Gelatin (Capsule), In a Base of Microcrystalline Cellulose and Fructo Oligosaccharides. These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease. References Bifidobacteria. Natural Medicines Comprehensive Database Web site. Accessed on October 21, 2006. Floch MH, Montrose DC. Use of probiotics in humans: an analysis of the literature. Gastroenterol Clin North Am. (2005) 34 (3): 547-70, x. Fuller, R. 1991. Probiotics in human medicine. Gut 32:439-442. Gilliland, S.E. 1996. Special additional cultures. In: Dairy Starter Cultures, T.M. Cogan and J.-P. Accolas, Eds., VCH Publishers, Inc., New York, pp. 233-248 Goldin, B.R. and S.L. Gorbach. 1992. Probiotics for humans. In: Probiotics. The Scientific Basis, Roy Fuller, Ed., Chapman and Hall, London, pp. 355-375 Golledge, C.L. and T.V. Riley. 1996. Natural therapy for infectious diseases. MJA 164: 94-95 Havenaar, R. and J.H.J. Huis in t Veld. 1992. Probiotics: a general view. In: The Lactic Acid Bacteria. Volume 1. The Lactic Acid Bacteria in Health and Disease, B.J.B Wood, Ed., Elsevier Applied Science, London, pp. 151-170 Kroger, M., J.A. Kurmann and J. L. Rasic. 1989. Fermented milks - past, present, and future. Food Technology. 43:92-98 Marteau, P. and J.-C. Rambaud. 1993. Potential of using lactic acid bacteria for therapy and immunomodulation in man. FEMS Microbiol. Rev. 12:207-220 Mullan, W.M.A. (2002). Probiotics. Properties, benefits,mechanisms of action, safety and enumeration. [On-line] UK: Available: http://www.dairyscience.info/probiotics.htm. Accessed: 1 August 2008. Revised 2004, December 2007, last revision February 2008. O Sullivan, M.G., G. Thornton, G.C. O Sullivan and J.K. Collins. 1992. Probiotic bacteria: myth or reality? Trends Food Sci. Technol. 3:309-314 Pedone C.A., Arnaud C.C., Postaire E.R., Multi-centric study of the effect of milk fermented by Lactobacillus casei on the incidence of diarrhoea. Int J Clin Pract (2000) 54 : pp 568-571. Sanders, M.E. 1993. Effects of consumption of lactic cultures on human health. Adv. Food Nutr. Res. 37:67-130 Sanders, M.E. 1993. Healthful attributes of bacteria in yogurt. Contemporary Nutrition 18 (5). 5