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Product Monograph for Herbal Magic Probiotics NPN 80055952 GENERAL INFORMATION Herbal Magic’s Probiotics is a formulation of live micro-organisms that helps restore the microbial balance in the gut flora. This formula includes 8 strains, providing a total of 25 billion colony forming units (CFU) per capsule. Probiotics should be taken daily to contribute to a natural, healthy gut flora which plays an important role in ensuring good digestive health and general health. The term probiotic refers to live microorganisms (bacteria) that have beneficial effects on the host’s microflora. 1 More than 500 species of bacteria reside in the human intestinal tract, which consists of organisms including Bifidobacterium and Lactobacillus.2 These bacteria have many functions, including supporting fibre digestion, vitamin synthesis, dietary nutrient absorption, and defence against harmful bacteria.3,4 If the delicate balance of the microflora is disrupted, its regular and vital functions are affected which may lead to harmful bacterial infection. The human body relies on a healthy digestive flora for numerous important functions including helping with food digestion and metabolism, absorption of nutrients, toxin elimination and in the prevention of pathogenic bacterial intestinal growth.5,6,7,8,9 RECOMMENDED USES Primary Uses: Helps support intestinal/gastrointestinal health; could promote a favorable gut flora. MECHANISM OF ACTION Research Suggests The adult gastrointestinal flora is composed of two kinds of flora: native symbiotic (mutual beneficial relationship for the bacteria and host) bacteria, and potentially harmful bacteria. Good health often results from a balance between the beneficial versus the harmful bacteria. Several medical, dietary and lifestyle factors can disturb the balance, such as inadequate dietary fibre, oral antibiotic therapy, ingestion of environmental toxins, alcohol use and/or stressful lifestyle. 10,11 Probiotics are considered beneficial and are referred to as "good" bacteria. The World Health Organization defines probiotics as “live microorganisms which when administered in adequate amounts confer a health benefit on the host”.12 The intestinal microflora consist of billions of bacteria that have two key functions: they play a role in metabolism by aiding food digestion, and also help to protect the body from developing infections. 13,14 Probiotics can also help reduce inflammation, a key contributor to insulin resistance, resulting in destruction of insulin-producing cells. 15,16 These bacteria help strengthen the intestinal wall, preventing the passage of bad bacteria into the bloodstream that can further increase inflammation and insulin resistance. 17 Probiotics can help alleviate stress, anxiety and improve mood; overall reducing factors which can contribute to weight gain. Research has demonstrated that probiotics can exert a noticeable effect on GABA levels, an inhibitory neurotransmitter involved in regulating many physiological and psychological processes, and also can lower the stress-induced hormone corticosterone. Lower levels of corticosterone result in reduced anxiety and depression related behaviors, which can play a major role in weight gain.18,19 Furthermore, UCLA researchers found that consuming probiotics, such as Bifidobacterium animalis subsp Lactis, for 4 weeks helps reduce activity in parts of the brain that control central processing of emotion and sensation—these areas are involved in mood, sensitivity to pain, anxiety, and stress. Participants underwent functional magnetic resonance imaging (fMRI) before and after the treatment to measure brain response to an emotion-oriented attention task and resting brain activity.20 Aside from supporting proper food digestion, researchers are also finding evidence of a relationship between good bacteria and the immune system. Certain bacteria in the gut influence the development of aspects of the immune system, such as correcting deficiencies and increasing the numbers of T cells.21 T cells are responsible for maintaining a good immune response by influencing the activity of other cell types throughout the body.22 Furthermore, researchers at Laval University in Quebec suggests that certain probiotics, specifically the Lactobacillus rhamnosus family, may help women lose twice as much weight compared to those who do not consume the bacteria regularly. Results demonstrate that the mean weight loss in the supplemented group was significantly higher when compared to placebo group after 12 weeks. Overall the women in the probiotic supplementation group lost on average 4.4 kilograms (nearly 10 lbs) compared to the placebo group who only lost 2.6 kg (about 5.5 lbs).23 Lactobacillus Lactobacillus is one of the major species of natural microflora found in the human body and is used for treating diarrhea. It is one of the most important, well established and well-researched micro-organisms that occupies the gastrointestinal tract. Lactobacillus probiotics offer a many health benefits, such as the treatment of diarrhea and other gastrointestinal conditions, as well as helping break down food.6,24 Bifidobacterium Bifidobacterium lactis contribute to a natural healthy gut flora which plays an important role in good digestive health. The beneficial lactic acid-producing bacteria Bifidobacterium forms a major part of the bacteria residing in the human intestinal tract.25 This particular strain of bacteria can help support a healthy balance of intestinal microflora and stimulate the natural defenses of the immune system.13,14 Bifidobacterium lactis are dominant in the micro-ecosystem of the colonic microbiota,26 and are recognized for their high oxygen resistance and ability to inhabit the colon.27 RECOMMENDED DOSAGE Youth and Adults aged 12+: 1 cap 2x/day with meals, at least 2-3 hours before or after antibiotics. CAUTIONS AND WARNINGS Consult a health care practitioner prior to use if you have fever, vomiting, bloody diarrhoea or severe abdominal pain. Discontinue use and consult a health care practitioner if symptoms of digestive upset occur, worsen, or persist beyond 3 days. May contain gluten and soybean. F OR PROFESSIONAL U SE O NLY F OR P ROFESSIONALS TO RECEIVE A PRINTED COPY OF THIS MONOGRAPH , CONTACT HERBAL M AGIC CLINICAL SUPPORT AT [email protected] OR 1-866-787-0050. 11/09/15 Rev 0 1 of 3 DISEASE/CONDITION INTERACTIONS Immune compromised condition: Do not use. DRUG INTERATIONS Take at least 2-3 hours before or after taking antibiotics. To prevent any interactions, all Herbal Magic centres offer our unique Medication Cross-Reference System, designed to provide evidence-based safe dosing options for Herbal Magic products such as Probiotics with other medications that the client is taking. FORMULATION Medicinal Ingredients per capsule: Probiotic blend……………………………………………………..25 billion CFU Lactobacillus acidophilus (LA-14) ..........................12 X 109 CFU Bifidobacterium animalis subsp. Lactis (BI-04) …..... 8 X 109 CFU Lactobacillus rhamnosus (Lr-32) ......................... 0.6 X 109 CFU Lactobacillus plantarum (Lp-115) …..................... 1.1 X 109 CFU Lactobacillus casei (Lc-11) ................................. 0.6 X 109 CFU Lactobacillus paracasei (Lpc-37) …...................... 1.1 X 109 CFU Bifidobacterium longum subsp. Longum (BI-05) .. 0.3 X 109 CFU Bifidobacterium bifidum (Bb-02) ......................... 1.3 X 109 CFU Non-medicinal Ingredients: Hypromellose, inulin, magnesium stearate, silica. Features: Non-GMO Vegan friendly Dye free For further information, please contact the Herbal Magic Scientific Advisory Team at 1-866-787-0050. REFERENCES 1 World Health Organization. Guidelines for the Evaluation of Probiotics in Food. Accessed May 22, 2015 from: http://www.who.int/foodsafety/fs_management/en/probiotic_g uidelines.pdf. 2 Leahy SC, et al. (2005). Getting better with bifidobacteria. J App Micrbiol, 98: 1303-15. 10 Doron S & Gorbach SL. (2006). Probiotics: their role in the treatment and prevention of disease. Expert Review of AntiInfective Therapy. 4(2):261–275. 11 Maity, TK, & Misra AK. (2009). Probiotics and human health: synoptic review. African J Food , Agriculture, Nutrition and Development 9.8: 1778(19). 12 Maity, TK, & Misra AK. (2009). Probiotics and human health: synoptic review. African J Food , Agriculture, Nutrition and Development 9.8: 1778(19). 13 Ezendam J & Van LH. (2006). Probiotics: Immuno-modulation and Evaluation of Safety and Efficacy. Nutr Rev, 64(1):1-14. 14 Gill H & Prasad J. (2008). Probiotics, Immunomodulation, and Health Benefits. Adv Exp Med Biol, 606:423-454. 15 Isolauri E, Kirjavainen PV, Salminen S. Probiotics: a role in the treatment of intestinal infection and inflammation?. Gut 2002;50:54-59. 16 National Diabetes Information Clearing.house (NDIC). Causes of Diabetes. Accessed May 22, 2015 from: http://diabetes.niddk.nih.gov/dm/pubs/causes. 17 British Journal of Nutrition; Effects of Lactobacillus acidophilus NCFM on insulin sensitivity and the systemic inflammatory response in human subjects; A. Andreasen, et al.; September 2010. 18 Bravo, J. A., Forsythe, P., Chew, M. V., Escaravage, E., Savignac, H. M., Dinan, T. G., … Cryan, J. F. (2011). Ingestion of Lactobacillus strain regulates emotional behavior and central GABA receptor expression in a mouse via the vagus nerve. Proceedings of the National Academy of Sciences of the United States of America, 108(38), 16050–16055. 19 Mishima, Y., Shinoda, Y., Sadakata, T., Kojima, M., Wakana, S., & Furuichi, T. (2015). Lack of stress responses to long-term effects of corticosterone in Caps2 knockout mice. Scientific reports, 5. 20 Tillisch, K., Labus, J., Kilpatrick, L., Jiang, Z., Stains, J., Ebrat, B., & Mayer, E. A. (2013). Consumption of fermented milk product with probiotic modulates brain activity. Gastroenterology, 144(7), 1394-1401. 3 National Center for Complementary and Alternative Medicine. Oral Probiotics: An Introduction. Accessed May 21, 2015 from: http://nccam.nih.gov/health/probiotics/introduction.htm. 21 Harvard Health Publication. How to boost your immune system: What can you do?. http://www.health.harvard.edu/stayinghealthy/how-to-boost-your-immune-system. Accessed June 6, 2015. 4 Frenkel M, et al. (2013). Integrating dietary supplements into cancer care. Integr Cancer Ther, 12(5):369. 22 Zou, W. (2006). Regulatory T cells, tumour immunity and immunotherapy.Nature Reviews Immunology, 6(4), 295-307. 5 Rolfe RD. The role of probiotic cultures in the control of gastrointestinal health. J Nutr. 2000;130(2 Suppl):396S-402S. 23 Sanchez, M., Darimont, C., Drapeau, V., Emady-Azar, S., Lepage, M., Rezzonico, E., ... & Tremblay, A. (2014). Effect of Lactobacillus rhamnosus CGMCC1. 3724 supplementation on weight loss and maintenance in obese men and women. Br J Nutr, 111(8), 1507-19. 6 de Vrese M, Schrezenmeir J. Probiotics, prebiotics, and synbiotics. Adv Biochem Eng Biotechnology. 2008;111:1-66. 7 Douglas LC, Sanders ME. Probiotics and Prebiotics in dietetic practice. J Am Diet Assoc. 2008;108(3):510-21. 8 Parvez S., Malik KA, Kang AH, et al. Probiotics and their fermented food products are beneficial for health. J Appl Microbiol. 2006;100(6):1171-85. 9 Collins D., Gibson G., Probiotics, prebiotics, and synbiotics: approaches for modulating the microbial ecology of the gut American Journal of Clinical Nutrition, 1999; 69(5): 1052S1057S. 24 Medline Plus. Lactobacillus. Accessed May 21, 2015 from: http://www.nlm.nih.gov/medlineplus/druginfo/natural/790.htm l 25 Wheatcroft PD, on behalf of Molecular and Cellular Research Team Agriculture and AgriFood Canada, Guelph, Ontario. Microorganisms in Foods and Around Them. http://www.magma.ca/~pavel/science//Foodbugs. html. 26 Bifidiobacterium lactis. Danisco, Received 2012; Version 6-D04. F OR PROFESSIONAL U SE O NLY F OR P ROFESSIONALS TO RECEIVE A PRINTED COPY OF THIS MONOGRAPH , CONTACT HERBAL M AGIC CLINICAL SUPPORT AT [email protected] OR 1-866-787-0050. 11/09/15 Rev 0 2 of 3 27 Ventura M., Zink Ralf., Rapid Identification, Differentiation, and Proposed New Taxonomic Classification of Bifidobacterium lactis. Appl Environ Microbiol 2002; 68(12): 6429–6434. LeBlanc, J. G., Milani, C., de Giori, G. S., Sesma, F., van Sinderen, D., & Ventura, M. (2013). Bacteria as vitamin suppliers to their host: a gut microbiota perspective. Current opinion in biotechnology, 24(2), 160-168. F OR PROFESSIONAL U SE O NLY F OR P ROFESSIONALS TO RECEIVE A PRINTED COPY OF THIS MONOGRAPH , CONTACT HERBAL M AGIC CLINICAL SUPPORT AT [email protected] OR 1-866-787-0050. 11/09/15 Rev 0 3 of 3