FORGET WHAT YOU THINK YOU KNOW ABOUT PROBIOTICS

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1 FORGET WHAT YOU THINK YOU KNOW

2 Overview The information contained in this report has far reaching implications for immune health, as well as disease management, and it has the potential to transform the well-being of your health. It is our goal that this document will also completely change what you know and understand about the vital role that digestive health plays in the overall healthy function of the body. It is a known fact that stress, diet, dehydration and medications can disrupt the natural balance of healthy bacteria in the gut, and can cause a cascade of health problems. One of the top 10 reasons people seek medical help is because of symptoms of chronic digestive challenges, such as gas, bloating or constipation. In some cases, they ve already been diagnosed with Crohn s Disease, Irritable Bowel Syndrome (IBS) or Ulcerative Colitis. Medications such as anti-diarrheals, antibiotics, bile binding agents, anti-inflammatory drugs and laxatives occasionally alleviate the symptoms, but have not proven to be curative. For more than a century, scientists have been exploring and recognizing the benefits of probiotics as a means to address digestive issues. Today, probiotics are now more popular than ever. Increased consumer awareness, driven by television commercials and popular health-talk programs, such as Dr. Oz, have played a key role in fueling the popularity and use of probiotic supplements and foods as a means for addressing digestive health. However, the results from the use of these products also have been lackluster because the commercially-produced foods and many of the probiotic supplements do not have the potency necessary to impact the ecology of the gastrointestinal tract. FORGET WHAT YOU THINK YOU KNOW

3 Thanks to the recently released results of the National Institute of Health s Human Microbiome Project (HMP), we re now better able to understand that each human being s microbiome is as unique as a snowflake. That means that the effectiveness of any medication or supplement is dependent upon its ability to adapt to the specific conditions of the body. As applied to probiotics, for a supplement to be effective, it must: a) Be of a strain that is found in the human microbiota b) Be supplemented in concentrations higher than what is found in the mircrobiota c) Be able to survive the gastrointestinal passage and be wild-type adapted for colonization in the gastrointestinal tract. This report will outline the exciting documentary and clinical evidence that makes Just Thrive Probiotic the most potent and effective probiotic available on the market. Also, you ll find additional information about the effectiveness of Just Thrive, that will help you understand the impact of adding this supplement to your regimen. There has never before been a more opportune time to understand that not all probiotics are effective because all people are not the same. Just Thrive is the most effective probiotic formulation due to its adaptability to individual ecosystems. To understand why this is so, it s important to begin with a little history. FORGET WHAT YOU THINK YOU KNOW

4 A Century of Research Showing the Way More than 100 years ago, Russian-born scientist and researcher Elie Metchnikoff was believed to be the first to discover the power of good bacteria, and is known as the father of natural immunity. One of the recipients of the Nobel Prize in Medicine in 1908, Metchnikoff worked at the Pasteur Institute. It was there that he recognized: dependence of the intestinal microbes on food makes it possible to adopt measures to modify the flora in our bodies and to replace the harmful microbes by useful microbes. Based on Metchnikoff s study and observation of people who ate fermented foods, he believed that the modification of flora in the gastrointestinal tract would lead to longevity. At the same time, the studies of Henry Tissier, a French pediatrician, found bifidobacteria dominant in the gut flora of breast-fed babies, and he observed clinical benefits from treating diarrhea in infants with bifidobacteria. Tissier documented that children with diarrhea had a low number of a particular bacteria (termed bifid bacteria) in their stools whereas healthy children had an abundance of this bacteria. Tissier s studies showed that given these bacteria to patients with diarrhea could help restore healthy flora to the gut. After Metchnikoff s death in 1916, the center of activity moved to the United States. It was reasoned that bacteria originating from the gut were more likely to produce the desired effect in the gut, and in 1935 certain strains of Lactobacillus acidophilus were found to be very active when implanted in the human digestive tract. Trials were carried out using this organism, and encouraging results were obtained especially in the relief of chronic issues. FORGET WHAT YOU THINK YOU KNOW

5 The term probiotics was first introduced in 1953 by German researcher Werner Kollath in a paper about nutrition and dental health. Probiotic was derived from the Latin preposition pro meaning for and the Greek noun bio meaning life. Kollath s usage was to describe organic and inorganic supplements necessary to restore health to patients suffering a form of malnutrition resulting from eating too much highly refined food. The following year, another German scientist, Ferdinand Vergin, turned the focus more toward microorganisms, in his article entitled Anti- und Probiotika. Scientists Daniel Lilly and Rosalie Stillwell recognized that the use of antibiotics, immunosuppressive therapy and irradiation, amongst other means of treatment, could cause alterations in the composition of the gastrointestinal tract and flora. The introduction of beneficial bacterial species to the gastrointestinal tract, therefore, was an option to re-establish the microbial equilibrium and prevent disease. In 1989, the term was further refined by Roy Fuller, who viewed it as live microbial feed supplement that beneficially affected the host by improving its intestinal microbial balance. Fuller s definition emphasized the requirement of viability for probiotics and introduced the aspect of a beneficial impact on the host. Although, this definition has been widely used by the entire scientific world, according to the currently adopted definition by FAO/WHO, probiotics are: Live microorganisms confer a health benefit on the host when administered in adequate amounts (FAO/WHO, 2001). FORGET WHAT YOU THINK YOU KNOW

6 To date, the most popular probiotic microorganisms used in commercial production of probiotic supplements and foods have been the Lactobacillus sp and Bifidobaceter sp. Other bacteria and yeast species commonly used as probiotics include: L. acidophilus, L. rhamnosus, L.gasseri, L. reuteri, L. bulgaricus, L plantarum, L. johnsonii, L. paracasei, L. casei, L. salivarius, L.lactis. Bifidobacterium species: B. bifidum, B. longum, B. breve, B. infantis, B. lactis, B. adolescentis. Probiotics have been shown to be effective in varied clinical conditions, ranging from infantile diarrhea, antibiotic-associated diarrhea, relapsing Clostridium difficile colitis, Helicobacter pylori infections, inflammatory bowel disease, female urogenital infection and surgical infections. Some strains also have proven to have beneficial effects on intestinal immunity by increasing the number of IgA and other immunoglobulins secreting cells in the intestinal mucosa. It also stimulates local release of interferons. It facilitates antigen transport to underlying lymphoid cells, which serves to increase antigen uptake. However, the results of National Institute of Health s Human Microbiome Project (HMP) has taught us that we don t know as much as we thought about the microbiology of the human body, particularly as it pertains to the gastrointestinal tract. Learning from Microbes The Human Microbiome Project (HMP), funded five years ago as an initiative of the National Institute of Health s Roadmap for Biomedical Research, involves approximately 200 researchers at 80 different top universities and research institutions around the world. Why the term Microbiome? It refers to the totality of microbes, their genetic elements (genomes), and environmental interactions in a defined environment, such as the human body. In this case, HMP is studying and characterizing the microbial communities located in the human body s nasal passage, oral cavities, urogenital system and gastrointestinal tract. FORGET WHAT YOU THINK YOU KNOW

7 The goals of HMP: 1. To take advantage of new, high-throughput technologies to characterize the human microbiome more fully by studying samples from multiple body sites from each of at least 250 normal volunteers; 2. to determine whether there are associations between changes in the microbiome and health/disease by studying several different medical conditions, and 3. to provide both a standardized data resource and new technological approaches to enable such studies to be undertaken broadly in the scientific community. The ethical, legal, and social implications of such research are being systematically studied as well. The HMP has created broad opportunities to study the variation in the human microbiome (with population, genotype, disease, age, nutrition, medication, and environment) and influence disease, while providing both a standardized data resource and technological developments to enable such studies to be undertaken broadly in the scientific community. Ultimately, it is hoped that the HMP will demonstrate that there are opportunities to improve human health through monitoring or manipulation of the human microbiome. Scientists found the initial HMP results astonishing! These results included: FORGET WHAT YOU THINK YOU KNOW

8 We are more bacteria than human! Ten trillion human cells versus 100 trillion bacteria cells. There are more than 1,000 different species of commensal organisms in the gastrointestinal tract. Bacterial genes outnumber human genes 150 to 1 (25,000 human genes versus 3.3 million microbial genes), which may explain many human functions. No two individuals have the exact same composition, not even twins. Disease is associated with a disruption in the gastrointestinal ecology. Pathogenic organisms are normal inhabitants of the gastrointestinal tract, such as H.pylori, Staphylococcus, E. Coli, etc. Alterations in the microbiome are confirmed to be associated with chronic disease states such as: IBS, Crohn s disease, asthma and even obesity. HMP marked the first time that human flora was extensively characterized, affording researchers the opportunity to thoroughly study the microbial population of the gastrointestinal tract as it relates to health, wellness and disease. Secrets of the GI Tract The gastrointestinal tract is made up of the following composition: Approximately 60 percent Bacteroidetes, Firmicutes, Proteobacteria and Actinobacteria. Lactobacillus belongs to the phylum Firmicutes and Bifidobacter belongs to the phylum Actinobacteria. Bacillus Spores also belong to the phylum Firmicutes FORGET WHAT YOU THINK YOU KNOW

9 From Henry Tissier s work, researchers were already aware that colonization of intestinal microbiota happens during vaginal birth and breast-feeding. But the HMP found that the composition of the species varies greatly between individuals. Collectively, there are more than 35,000 species of gastrointestinal bacteria identified in humans. There s evidence to show co-evolution of the host and its indigenous microbiota, allowing microbiota control of certain components of the gastrointestinal tract without massive, damaging host response. Gut microbiota exhibit high levels of adaptation to their habitat and to each other, presenting a case of microevolution. This is important when considering probiotic therapy. Because our understanding of the form and functionality of microbiota has changed over the last four or five years, probiotic formulations also have to change. Microbiodata communicate with and influence human cell behavior by signaling molecules and recognition of bacterial epitopes by both intestinal epithelial and mucosal immune cells. Not all species are able to or are designed to inhabit all tissue types. There are significant differences between strains that inhabit and influence the epithelial, mucosal and lumen sites of the gastrointestinal tract. The HMP research reinforces the power of the Just Thrive formula by documenting that intestinal microbiota are not homogeneous. The number of bacterial cells present in the human gut shows a continuum that varies by location and tissue type. FORGET WHAT YOU THINK YOU KNOW

10 Establishing the Efficacy of Probiotics The Food Standards Agency conducted a study in conjunction with Reading University (Dr. G.R. Gibson, Dr. G. Rouzaud, Dr. J. Brostoff and Dr. N. Rayment) in the United Kingdom to evaluate the probiotic effect of commercial products in the human gut, and whether there was any impact on gut flora. The study evaluated the survivability of common probiotics through the gut, examining 35 strains from commercial products, primarily Lactobacillus sp. and Bifidobacterium sp. The results: None were able to survive the gastric juices in the stomach with any viability or ability to recover when the stomach ph was 1-3. When the ph was 2-3, 18 of the 35 survived; a survival rate of about 50%. Of those 18, only six showed viability in the presence of bile acid salts and would have a chance to make it to the large intestines. Four of the six showed viability in the lower intestine. That means only 11% of the strains were effective (4 of 35). In addition, other researchers have also found that taking billions of cells of multiple strains also is no guarantee of a probiotic s effectiveness. Most of those cells likely will not survive the tablet or encapsulation process. The Reading University study concluded: Results of interaction with the residential microflora showed that addition of probiotic did not affect significantly the total number of bacteria growing in the continuous culture. Little difference was also seen on the levels of main bacterial species numerated. As a result of these studies, researchers were able to establish criteria by which the efficacy of probiotics could be measured. This standard requires that a probiotic: FORGET WHAT YOU THINK YOU KNOW

11 Be a strain that is found in the microbiota If a strain doesn t currently exist in the gastrointestinal tract of an individual, it cannot compete for space and resources with the individual s natural flora. It doesn t have a place. If it s a strain not found in the individual s microbiota, it may not function in harmony with the other strains present. The likelihood of this outside strain colonizing and surviving to offer a probiotic benefit is rare. Be supplemented in concentrations higher than what is found in the microbiota Probiotics work through stimulating either by sheer critical mass of the strain, by increased production of signaling bio-markers and/or by competitive exclusion. Commonly used probiotic strains such as Lactobacillus and Bifidobacterium sp. are found in the microbiome in numbers exceeding 20 trillion. The gastrointestinal tract has the surface of a tennis court and is coated with bacteria. Lactobacillus and Bifidobacterium sp. currently exist in the gastrointestinal tract in concentrations exceeding 20 trillion. Most commercial probiotic supplements at most offer 50 billion, which is less than three percent of the concentration that already exists. It s hard to make an impact in that environment with 50 billion bacteria. FORGET WHAT YOU THINK YOU KNOW

12 Be able to survive the gastrointestinal passage and be wild-type adapted for gastrointestinal colonization. Endogenous species of gastrointestinal bacteria are mostly strict anaerobes if they can grow in production, they are not wild-type and thus may no longer be suited to life in the gastrointestinal tract. A few billion cells added to trillions won t have a chance unless it is specifically adapted to a particular tissue i.e. epithelia cells, mucosal or lumen. A major function of a probiotic is its evolutionary-developed symbiosis with its host and the host s flora. These functions and genes have been selected for over thousands of years. This innate genotype has to be conserved. Nature has designed a very efficient supplemental probiotic Bacillus spores one of the key ingredients that make Just Thrive so effective. More about Spores used in Just Thrive Bacillus spores are the most widely studied and most widely used probiotics outside of the supplement market. They were the first prescription probiotics beginning in 1958 in Europe Enterogermina (Sanofi-Aventis, Italy) and Bacti-Subtil (Aventis Phara, France). They also were the first commercial probiotics used extensively in agriculture and aquaculture AlCare, BioGrow, 2B, NeoFermBS10, LiquaLife, etc. FORGET WHAT YOU THINK YOU KNOW

13 Bacillus Subtilis, Bacillus Coagulans, Bacillus Clausii are widely used and studied. B.subtilis is a gram-positive, soil-dwelling bacterium that has the ability to differentiate into endospores. Spore formation in B.subtilis is a simple developmental event that involves the generation of two different cell types (forespore and mother cell), each with different programs of gene expression and different developmental fates. These spores are metabolically dormant and highly resistant to a variety of environmental challenges, including UV and gamma radiation, reactive oxygen, high and low temperature, acid and alkali conditions, hydrolytic enzymes and organic solvents. Spores can remain dormant for long periods of times (perhaps up to 50 years), but will germinate when they encounter a nutrient-rich environment containing one or more of two specific germinates (L-alanine and/or a mixture of L-asparagine, fructose, glucose and potassium ions). Spores are found in the gastrointestinal tracts of insects, animals and humans, indicating a universal function as a commensal probiotic. There have been numerous studies and a long history of use which confirm the survivability of spores through the gastrointestinal tract. These studies have shown that spores are well-adapted to germinate in the small intestines, grow and proliferate. They can then re-sporulate in the lower gastrointestinal tract. This ability to resporulate is clearly an evolutionary adaptation as several functions o f Bacillus spores require resporulation in the lower gastrointestinal. The environment is simply a vector to transfer bacteria from host to host, making the spores better suited for life in the gastrointestinal tract, even though they are passed via the environment. FORGET WHAT YOU THINK YOU KNOW

14 Spores also produce a significant number of potent antibiotics that control bacterial overgrowth in the gastrointestinal tract, such as coagulin, subtilisin, Amicoumacin, Surfactin, IturinsA and Bacilysin. They conduct competitive exclusion (CE) of pathogenic organisms to help maintain microbiota balance. CE is accomplished either by competition for space and nutrients and/or eliciting a host response that causes the host to eliminate the invading species. Spores have the ability to increase the numbers of the important gastrointestinal commensals, such as Bacteroides and Lactobacillus. In addition, Bacillus spores have been shown to: Be stable in the digestive tract only in spore form; Be critical in the development of Gut Associated Lymphoid Tissue (GALT) in cooperation of Bacteriodes Fragilis sp., the largest population in the gastrointestinal tract; Produce potent activation and proliferation of lymphocytes in the Peyer s patch; Cause the production of important immune cytokines in cytokines in mesenteric lymph nodes (MLN) (IL-1a, IL-5, IL-6, IFN-g and TNF-a) and in the spleen (IFN-g and TNF-a), and Interact with Toll-like receptors(tlr). In particular, vegetative cells of B. subtilis and other Bacillus sp. were shown to up-regulate expression of TLR2 and TLR4. This leads to amplified innate immune response via macrophages, monocytes, B-cells and Dendritic cells. Dendritic activation is important to create link between innate and adaptive immunity. FORGET WHAT YOU THINK YOU KNOW

15 Bacillus probiotics have been shown to produce key enzymes that help the digestion of food products and alleviate bloating, cramping and discomfort. Enzymes like alpha-amylase, lactase, protease and lipase are improved with the use o f Bacillus. Most important, dysbiosis (the presence of harmful bacteria and the imbalance of good bacteria in the gastrointestinal tract) is the main cause of digestive disorders, and it can be argued as being the root cause of most disease. Dysbiosis is also responsible for incomplete digestion of consumed foods. Studies have shown that Bacillus probiotics prevent the growth of harmful bacteria and promotes the growth of beneficial bacteria, thus alleviating dysbiosis. Bacillus probiotics also produce important amounts of menaquinones and biotin in the large intestines. The absorption rate of these vitamins is high because they are produced at the sight of absorption. Bacillus also digests resistant starches and non-starch polysaccharides (NSP; major components of dietary fiber) to short-chain fatty acids (SCFA), mainly acetate, propionate, and butyrate. SCFA stimulate colonic blood flow and fluid and electrolyte update. Bacillus neutralizes genotoxic compounds encountered in the gastrointestinal tract, such as vomitoxin, which is found in wheat, corn and other grains. Add to the list the reduction of cholesterol, which primarily has been seen with the consumption of Bacillus subtilis from natto, a Japanese fermented soybean dish. Bacillus has been shown to digest cholesterolcausing fats in the gastrointestinal tract to reduce absorption of that form. FORGET WHAT YOU THINK YOU KNOW

16 At the New Frontier of Digestive Health Until now, there have been no effective spore-based probiotics. Enter spore expert, Dr. Simon Cutting, Ph.D. Dr. Cutting earned his doctorate at Oxford University in microbial genetics before being awarded a post-doctoral fellowship to carry out research at Harvard. Dr. Cutting is currently the head of Biomedical Sciences at Royal Holloway, University of London at the School of Biological Sciences. His pioneering work in the field has led to some important conclusions about the effectiveness of spore-based probiotics. For example, using verified, branded and registered strains is the only way to ensure proper characterization. Likewise, using proprietary technology to deliver efficacious bacillus spore probiotics in a consortium can introduce BILLIONS of live probiotic cells daily. Why a consortium? To match the evolutionary design of bacillus as a probiotic, it has to be formulated into a consortium of common species. Subtilis, Clausii, Coagulans and Indicus are often found together in the natural environment. The strains exist in the gastrointestinal tract in a consortium and studies indicate they support one another. Probiotics in nature are simply never found as a single strain. Complimentary strains work together for critical, optimum efficacy. One strain in particular, Bacillus Clausi, has been tested for more than 50 years in the largest-selling, prescription probiotic product. And new and highly effective Bacillus spore, Bacillus Indicus HU36, is a patented, carotenoid rich strain of the highest bioavailability. Bacillus Indicus works together with other strains to transform digestive and immune system health. FORGET WHAT YOU THINK YOU KNOW

17 The Power of Spore-released Cartenoids After three years of critical research headed up by Dr. Cutting, the COLORSPORE consortium sought to gain a clearer understanding of the bacterial carotenoids that have been discovered and to characterize their antioxidant activity and bioavailability. This led to the discovery of HU36. Leading health and nutrition experts recommend that the general population consume five different colored fruits and vegetables. These edible pigments found in fruits and vegetables contain mostly carotenoids. Antioxidant activity is the main feature of carotenoids, and purified carotenoid extracts are a significant part of the dietary supplement market. Examples of these supplements include alpha-carotene, beta-carotene, lutein, zeaxanthin and lycopene. Carotenoids have been found to provide health benefits in the treatment of cancer of the cervix, bladder, lung and prostrate, as well as macular degeneration. Unfortunately, most forms of carotenoids in commercially-available products are lost within 20 minutes of being exposed to gastric juices and are not readily bioavailable. However, by making carotenoids available via the spores of Bacillus indicus HU36, the carotenoids are more stable and able to survive the stomach acids. These carotenoids are stronger antioxidants and bioaccessible as they are absorbed by the intestinal cells. HU36 offers a unique approach to probiotic therapy because they produce highly therapeutic compounds like carotenoids and ubiquinones, a liquid-soluble quinone found in mitochondria. Once Again What Attributes Meet the Probiotic Criteria? When evaluating probiotic products, research studies have clearly established these criteria by which the efficacy of probiotics could be measured. This standard requires that a probiotic: FORGET WHAT YOU THINK YOU KNOW

18 1. Be a strain that is found in the microbiota 1. All strains should be human derived and have a firm place in the microbiota. 2. Be supplemented in concentrations higher than what is found in the microbiota 1. For example, a dosage of more than three billion live cells daily is 2,000 times higher than the native population in the gastrointestinal tract. 3. Be able to survive the gastrointestinal passage and be wild-type adapted for gastrointestinal colonization. 1. Spores use the environment as a vector for transfer from host to host and are uniquely adapted to be stable in the environment and in the gastrointestinal tract, capturing the power of millions of years of evolution. Kiran Krishnan, Microbiologist Just Thrive Probiotic & Antioxidant FORGET WHAT YOU THINK YOU KNOW