1. What are Probiotics?
2. How do Probiotics work?
3. How do Probiotics stimulate the Immune system?
4. Are Probiotics safe?
5. Is Overdosing Possible?
6. Why should I take Probiotics?
7. How soon should I see results using Symbion™?
8. When should Symbion™ not be taken?
9. Can Symbion™ improve digestion and manage digestive illnesses such as Irritable Bowel Syndrome (IBS)?
10. Supporting Clinical Data for Probiotics in the treatment of IBS and Ulcerative Colitis
11. How is Symbion™ stored? Does it need refrigeration?
12. How do I take Symbion™?
13. How long should I take Symbion™?
14. What are the Ingredients of Symbion™?
    
    

1. What are Probiotics?

Probiotics are the opposite of antibiotics. They are the natural, beneficial, live microbial (Bacteria) supplements known to maintain intestinal balance of the gut micro-flora (micro-organisms resident in the gastrointestinal tract). The Joint FAO/WHO Working Group Report on Drafting Guidelines for the Evaluation of Probiotics in Food, 2001, defines Probiotics as “Live Micro-organisms, which when administered in adequate amounts, confer a health benefit on the host”. They serve to:

• PROTECT the body against pathogens.
• MAINTAIN vital chemical and micro-flora balance in the GI tract.
• PRODUCE essential vitamins and hormones.
• HELP stimulate immune response.

The average adult colon contains roughly 4 pounds of bacteria, comprising 400 species of microorganisms. The GI tract should ideally contain 85% friendly bacteria and 15% unfriendly bacteria. In many people this ideal balance is not maintained due to the effects of poor nutrition, stress, prescription drugs (e.g. antibiotics), pollutants and environmental changes.

The digestive system is the gateway to good health. Poor functioning of the gut can lead to poor health in other areas of the body. Slow intestinal transport can lead to constipation, a decrease in acidic balance can lead to increases in pathogens (e.g. Clostridium difficile for diarrhea), while increased acidity can lead to GERD (Gastro-intestinal reflux disease). An immune response can be produced from the passage of incompletely digested food molecules passing through the intestinal wall, possibly leading to autoimmune disorders.

Specific strains of Probiotics, like Symbion™ can help maintain a healthy balance of essential, friendly bacteria in the digestive tract, where about 70% of the immune system is located.

2. How do Probiotics work?

Lactobacillus and bifidobacteria are the most abundant microorganisms in Probiotic containing food products and supplements. The three live ingredients of Symbion™ (Bacillus coagulans, Bacillus subtilis and Enterococcus faecium) are Lactobacilli, which promote health. They turn lactose (milk sugar) into lactic acid, lowering the pH of the colon and inhibiting overgrowth of harmful bacteria (e.g., Clostridium, Salmonella, Shigella and E.coli).

Lactobacillus species, have been used in promoting health benefits throughout the world, for a variety of conditions supported by scientific studies (see Refs). These include:

• Improving health of the digestive tract
• Increasing immune function
• Decreasing cholesterol and lipid levels
• Decreasing prevalence of vaginal infections.

Refs.
Rolfe R.D. The role of probiotic cultures in the control of gastrointestinal health.J.Nutr, 2000;130(2S);396S-402S

Hatakka K. et al. Effect of longterm consumption of probiotic milk on infection in children attending daycare centers; double blind randomised trial.BMJ.2001;332:1-5

Meydani S.et al. Immunologic effect of yogurt. Am J.Clin Nutr.2000;7:861-872.

Anderson et al. Effect of fermented milk(yogurt) containing Lactobacillus acidophilis L1 on serum cholesterol in hyper cholesterolemia in humans. J Am.College of Nutr.1999;18:43-50

Hove et al. Lactic acid bacteria and the human gastrointestinal tract.Euro,JClin.Nutr.1999;53:339-350

Reid G. Probiotic agents to protect the urogenital tract against infection. Am.J.Clin.Nutr.200173(S);437S-443S

A role of Probiotics in defense against enteric pathogens, treatment of contaminated bowel syndrome, or re-constituting the intestinal flora after antibiotic use is conceptually sound (Gabriella et al 2001,Intestinal Microbiology,2001,2(1):27-42

3.How do Probiotics stimulate the immune system?

The intestine is the largest immunological organ in the body, containing 70 to 80% of all the IgA producing immunological cells. Humans, like all warm-blooded animals, live in symbiotic association with a large, varied population of microorganisms in their gastrointestinal tract. This provides them with the enhanced resistance to infectious diseases, through gastro-mucosal immunological control.

Under normal healthy conditions, the level of immunity is satisfactory. However, with stress, over use of antibiotics and significant abnormal dietary changes, the natural balance of microorganisms is disturbed and vulnerability to infection and autoimmune illness occurs. In the absence of a balanced enteric gut flora the intestinal immune system is underdeveloped.

Dietary supplementation with live Lactic Acid microorganisms (Probiotics), such as Symbion™, will repair and normalize an imbalance in the gastrointestinal tract. Probiotics stimulate an immune response and resistance to infections (Perdigon, Fuller & Raya, 2001). These reviewers state that the Probiotic approach is attractive, because it is a reconstitution of the natural condition. It is a means of repairing a deficiency rather than the addition of foreign chemicals to the body, which may have toxic consequences or, as in the case of antibiotics, induce resistance and compromise subsequent therapy.

Ref: Gariella Perdigon, Roy Fuller and Paul Raya. “Lactic Acid Bacteria and their effect on the immune system.”. Intestinal Microbiology, 2001.2(1):27-42

4. Are Probiotics Safe

Historically Lactobacilli and Bifidobacteria associated with food have been considered safe (Adams & Marteau “On the safety of Lactic Acid Bacteria.” 95 Int.J.Food Micro 27:26.) Many bacteria are normal commensals of the mammalian gut flora and their established safe use overtime in a diversity of foods and supplement products worldwide, support this conclusion (FAO/WHO Working Group Report on Drafting Guidelines for the Evaluation of Probiotics in Food, London, Ontario, Canada, May 2000).

Symbion™ is composed of three GRAS (Generally Recognized As Safe) friendly bacteria, Bacillus coagulans, Bacillus subtilis, and Enterococcus faecium. The three ingredients are contained in easily administered capsules, also containing FOS (fructo-oligosaccharide) to keep the friendly bacteria alive for shipping and storage. Refrigeration is not required.

5. Is Overdosing Possible?

NO. According to the published scientific and medical literature, none of the organisms in Symbion™ have ever been found to be toxic, cause irritations, or allergic response. For Probiotics to be effective they must contain a minimum of 10 million to 100 million beneficial bacteria per dose. Symbion™ contains more than four times the minimum required.

6. Why should I take Probiotics?

The large intestine in adult humans contains the most complex, diverse, gastrointestinal floral population, demonstrating a level of metabolic activity comparable to the liver, controlling intestinal, mucosal protection and function, immune development and animal growth. Mucosal defense by the normal gut flora is through competition with potential pathogens and exchange of regulatory signals with the gut and immune cells in the gut mucosa (O`Sullivan et al, 2005). The bacteria stimulate tissues of the gut mucosa to produce antibodies to pathogens. The immune system recognizes and fights harmful bacteria,but leaves the friendly species alone--- a tolerance developed in infancy. (Wikipedia, 2006)

In a normal healthy person there is a correct balance between the 85% friendly bacteria and the 15% unfriendly bacteria in the gut. With increasing age, the negative effects of stress, use of antibiotic and harmful pharmaceuticals (e.g. antacids, chemotherapy, steroids etc.) coupled with digestive illnesses (e.g. from travel, from unhealthy diets) this balance is disrupted and the Lactobacilli (friendly, or beneficial Probiotic bacteria) are among the first to become depleted. This then creates the need for supplementation of beneficial Probiotic bacteria, like Symbion™ to restore and maintain the normal, healthy gastrointestinal flora balance. These Probiotics also prevent bacteria species that would harm the host from colonizing the gut---“a barrier effect.”

Probiotics may also modify the immune system and make it less likely to develop autoimmune illnesses. They can induce certain cells to produce other cells called cytokines, which can either “up regulate” (to turn on the immune system) to fight infection or “down regulate” the immune system when not fighting infection, so that auto-immune diseases are not developed (Aubrey, 2006). Animals or man without a normal gut flora are more easily infected.

Refs:
Wikipedia (2006) “Gut Flora”. http://en.wikipedia.org/wiki/Gut_flora

O'Sullivan et al (2005) “Probiotics: An Emerging Therapy” Current Pharmaceutical Design 11, 3-10

Aubrey A. (2006) National Public Radio, Dec10, Your Health. “Pros and Cons of Probiotics.”

7. How soon should I see results using Symbion™?

Results of using Symbion™ will vary from person to person, because of differences in their digestive condition .In some cases, changes are found rapidly, within a few days, but in others it may take a few weeks. A small number of people may need a few months to observe the benefits. Everyone in need, with time, should obtain benefits in their digestive condition and associated symptoms.

8. When should Symbion™ not be taken?

A. Together with antibiotics?
Since antibiotics by definition will kill both good and bad bacteria, we recommend that to preserve the benefits of Symbion™ it should be taken as far away from the antibiotic as possible. Symbion™ will not interfere with any medications you might be taking.

B. During pregnancy?
Probiotic supplements like Symbion™ have been shown to be safe, containing naturally occurring, beneficial microorganisms. However, it is advisable to consult your physician for their recommendation in individual cases.

C. During certain illnesses?
Symbion™ can be taken safely by mouth to restore and maintain the normal balance of gut microflora conditions, during most digestive illnesses, including diabetes. Always ask your doctor if you have questions.

9. Can Symbion™ improve digestion and manage digestive illnesses such as Irritable Bowel Syndrome Bowel Syndrome (IBS)?

It used to be thought that Probiotics simply aided digestion, but particularly in Europe and Japan, over the last decade, some health benefits have been associated with these products. In the United States growing clinical research evidence is supporting the anecdotal evidence of the health support of Probiotics, including effects on mucosal barrier dysfunctions, including diarrhea, inflammatory bowel syndrome and allergies (Walker, 2006).

Irritable Bowel Syndrome (IBS) is a common (50 to 60 million sufferers in the United States), often chronic gastrointestinal disorder, being one of the most common seen by primary care physicians. The digestive disorder presents with abdominal pain, changes in bowel movements (diarrhea, constipation or both, alternating), gas, bloating and gut distention. These symptoms impair personal, social and work related activities, producing a great reduction in “Quality of Life”.

Co-factors of this alteration in physiological function (how the body works) are severe fatigue, prolonged tiredness and musculoskeletal pain. In many cases of IBS, the above mentioned symptoms are linked to conditions observed in Fibromyalgia (widespread muscle pain, fatigue, multiple tender points, cognitive and memory problems and sleep disturbances.

The symptoms of IBS result from what appears to be a disturbance between the gut, the brain and the autonomic system, that alters regulation of bowel motility or sensory function (IFFG, About Irritable Bowel Syndrome-www.aboutibs.org). Two studies found that 78% to 84% of sufferers with IBS had gut bacterial overgrowth (Pimental,et al,2000; Pimental, et al, 2003.)

Probiotics like Symbion™ while not a cure has been shown to alleviate the unpleasant symptoms of IBS, possibly through a rebalancing or assistance in maintaining the natural gut microflora milieu. (Quigley, 2005)

Refs:
Walker A. (2006) “Mechanisms of Action of Proboiotics.” Ist Int.DIA Conf. “Developing Probiotics as Foods and Drugs.-Scientific and Regulatory Challenges.” Oct 16-17,Univ of Maryland.

Pimental et al (2000) “Eradication of small intestinal bacterial overgrowth reduces symptoms of Irritable Bowel Syndrome.” Am. J.Gastroenterol. 95(12):350-6 PMID 11151884.

Pimental et al (2003) “Normalization of Lactulose Breath Testing Correlates With Symptom Improvement In Irritable Bowel Syndrome. A Double Blind, Randomised, Placebo Controlled Study”. Am. J.Gastroenterol. 98(2):412-9.PMID 12591062.

Quigley E.M. (2005) “The Use of Probiotics in Functional Bowel Disease.” Gastroenterol.Clin.North Am.34 (3):533-45.PMID 16084312

10. Supporting Clinical Data for Probiotics in the treatment of IBS and Ulcerative Colitis

Bacillus coagulans significantly improved abdominal pain and bloating in patients with IBS (Laryisa Hun; PMID: 19332970) https://pubmed.ncbi.nlm.nih.gov/19332970/

Efficacy and Safety of Bacillus coagulans in irritable bowel syndrome: A prospective, interventional, randomized, double blind, placebo controlled clinical study [CONSORT Compliant] (Anil Kumar Gupta, Chiranjit Maity; PMID: 33545934) https://pubmed.ncbi.nlm.nih.gov/33545934/

Health Canada Approval for E. faecium and B. subtilis formula for IBS: https://lallemand-health-solutions.com/en/blog/can-you-take-probiotics-if-you-live-with-ibs/

Bacillus coagulans clinical trial for IBS: https://nutritionj.biomedcentral.com/articles/10.1186/s12937-016-0140-6

Health Canada Approval of E. faecium and B. subtilis for help in reducing diarrhea: https://health-products.canada.ca/lnhpd-bdpsnh/info.do?licence=80054028

Probiotic containing E. faecium and B. subtilis for the induction of clinical remission in a Chinese population with Ulcerative Colitis: https://ncbi.nlm.nih.gov/pms/articles/PMC6288505/

11. How is Symbion™ stored? Does it need refrigeration?

Do not refrigerate Symbion and do not store it in direct sunlight. It should be kept at room temperature. Refrigerating it for more than two weeks will cause it to go dormant, while temperatures above 130F for more than two weeks will deteriorate the live bacteria.

12. How do I take Symbion™?

The suggested beginning dose is one capsule taken after a meal. After one week, increase to one capsule twice daily. At four weeks, increase to three capsules, one with each meal. Up to six capsules a day may be taken over time if necessary, but the recommended long term maintenance dose is three or four per day.

If at any time, going up in dose causes any discomfort, go back to the previous dose for another week or two before trying to increase the dose again. This is known as a "healing response" and can be avoided entirely by going up in dose slowly.

Refrain from eating sweets (e.g., sugar) if possible for the first one to two months, as it feeds the bad bacteria in the intestines.

The vast majority of people report improved bowel function after taking Symbion™, however some may already have diarrhea or constipation. In both cases, we recommend taking a good fiber supplement, such as psylium husks or guar gum to assist in productive bowel movements. Check with your doctor or pharmacist for brands they recommend. Fiber should always be taken on an empty stomach, either 30 minutes before your meal and Symbion™, or 3 hours after a meal.

13. How long should I take Symbion™?

Symbion™ should be taken every day to help maintain good bowel function and a healthy balance of beneficial microflora in the intestines.

14. What are the Ingredients of Symbion™?

Ingredients: Bacillus coagulans (400 million CFU*), Bacillus subtilis (200 million CFU*), Enterococcus faecium (200 million CFU*). Fructo-oligosaccharides (Chicory root inulin 1,200 mg)

*CFU - Colony Forming Units

Contains no yeast, corn, gluten, egg, sugar, salt or starch.

Symbion™ is manufactured in the U.S.A. in a GMP (Good Manufacturing Practices), FDA Approved pharmaceutical facility, using only the purest, pharmaceutical grade ingredients. Each batch is DNA tested for ingredient purity, quality, and CFU concentration to ensure uniformity.