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Bacillus Coagulans PREBIOTICS/ PROBIOTICS Bacillus coagulans : Probiotic of choice IntroductIon stomach. Spores then germinate and proliferate MUHAMMED MAJEED within the GI tract within a few hours. After REZA KAMAREI robiotics have recently received germination, B. coagulans is metabolically considerable attention by the active as part of facultative anaerobes in the Sabinsa Corporation P intestine, producing L-(+)-lactic acid, as primary healthcare professionals and the 20 Lake Drive public. Prior to considering Bacillus product of fermentation. The main mechanism East Windsor, NJ 08520, USA coagulans , we need to know what probiotics for survival and proliferation of B. coagulans is are. Probiotics are live microorganisms which, “Competitive Exclusion”. Competitive exclusion when administered in adequate amounts, is generally applied via competition for limited confer a health benefit on the host (1). From nutrients. However, the acidic environment this definition, it is concluded that probiotics created by production of L-(+)-lactic acid can be a components of foods, dietary prevents the growth of pathogenic microbes supplements and drugs. Furthermore, definition and allows growth of B. coagulans which does not talk about the age of the subject or ultimately dominate the microflora. route of administration. It does not talk about Furthermore, B. coagulans also produces type of the conferred health benefit either. bacteriocins (antimicrobial proteinaceous compounds) that are inhibitory towards both Gram positive and Gram negative bacteria. Bacillus coagulans Suggested dose of B. coagulans is 100 to 200 (LactoSpore ®) million spores, 3 times per day. B. coagulans is temporary resident of GI tract. In other words, Bacillus coagulans is the taxonomic following discontinuation of its administration, it nomenclature of the microorganism is slowly excreted from body – usually within deposited to the American Type Culture seven days. Collection (ATCC) facility under the number 7050. Bacillus coagulans was originally known as Lactobacillus sporogenes . probIotIc oF choIce Therefore, the names Bacillus coagulans and Lactobacillus sporogenes have been and are There are seven reasons why LactoSpore ® used in the literature interchangeably. can be considered as probiotic of choice. LactoSpore ® is Sabinsa Corporation’s tradename for this probiotic. The most reason 1 – history of use comprehensive review on LactoSpore ® is Dietary ingestion of lactic acid producing written by Majeed and Prakash (2). bacteria has a substantial history of use and the safety record is excellent. For example, characteristic Features lactic-acid bacteria are used in starter cultures Bacillus coagulans , a nonpathogenic / for fermentation in foods such as yogurt, kefir, nontoxicogenic microorganism, is a rod-shaped, sauerkraut, sausage, sourdough bread, Gram positive, endospore-forming (spore is Nigerian “Ugba” and Korean “Kimchi”. They formed within the cell) bacteria. It is are also utilized for production of enzymes facultative anaerobe, grows optimally at 37°C published by srl that are used for food production – e.g., and pH in the range 5.5 to 6.2. B. coagulans Via Mario Donati, 6 insoluble glucose isomerase enzyme. Lactic requires nutritionally complex environment in 20146 Milano - Italy acid bacteria have also been used extensively which it derives energy via fermentation or Tel. 0039 02 83241119 in dietary supplements – alone or with catabolism of carbohydrates. It is more acid- vitamins, minerals, prebiotic, etc. Fax 0039 02 8376457 tolerant than pathogenic and spoilage www .b5srl . com microorganisms. reason 2 – Stability of Spores Due to its spore-forming nature, B. coagulans probiotic Features is resistant to most chemical and physical When ingested, spores of B. coagulans can conditions – e.g., heat and acid – and survives withstand the acidic environment of the manufacturing, shipping and storage with no PREBIOTICS / PROBIOTICS MARCH/APRIL 2012 19 diarrhea, 87.9% of 46.8 mg/dl); however there was no change infantile diarrhea and in serum triglyceride levels (Figure 2). 65.4% of Constipation conditions showed Clinical Study 4: Infant Gastrointestinal improvement (Table I). Health (India) In this study, sixty diarrhea cases, three Clinical Study 2: constipation and three jaundice cases Infant Gastrointestinal were randomly selected. Dose Health (India) administered was 15 million spores In this study, 112 L. sporogenes per day and the recovery newborn infants in period was 1.8 days (6). 81.7% of the rural India were diarrhea condition and 100% of the randomized to receive constipation and jaundice conditions were a daily oral dose of successfully treated. No complicating side 100 million effect was seen. The authors concluded Lactobacillus Figure 1 – SAMI (Sabinsa) FDA-inspected facility for production of sporogenes LactoSpore® (Bangalore, India). or a placebo loss of viable count. B. coagulans does not for one year (4). Morbidity was require refrigeration conditions and is room- monitored each week for 12 temperature stable. Each batch of months. Ninety four experienced LactoSpore® produced in Sabinsa’s FDA- diarrhea due to rotavirus inspected biotechnology facility is inspected infection. The group fed L. for sporulation and purity (Figure 1). The sporogenes had fewer episodes LactoSpore® powder produced in this of diarrhea (3.4 vs. 8.6 in the facility is standardized to 15 billion spores placebo group) and less number per gram. Lower spore counts – e.g., of days of illness (13 days vs. 35 Table I – Clinical study 1: Gastrointestinal health (Japan). 6 billion spores per gram – are also days in the placebo group). The that L. sporogenes produced. episodes of diarrhea were of has proved to be shorter duration (3.6 days vs. an efficacious and reason 3 – GraS Status 6.8 days in the placebo group). very safe drug for In December 2008, LactoSpore® was self- These observations suggest that treatment of affirmed GRAS (Generally Recognized As the prophylactic feeding of neonatal diarrhea. Safe) by an independent panel of Lactobacillus has a preventive recognized experts qualified by their effect on the incidence and Clinical Study 5: scientific training and relevant national and duration of acute rotavirus Acute and international experience to evaluate the diarrhea. Chronic Diarrhea safety of food and food ingredients. It was (China) recommended by this panel of experts Clinical Study 3: Serum Lipid In this study, the that 250 million CFU (Colony Forming Profile (India) efficacy and safety Unit) of spores/person/day is safe. Up to In this study, short term of Bacillus 10 ppm of LactoSpore® at the hypolipidemic effects of oral coagulans tablets concentration of 15 billion spores per L. sporogenes therapy (360 million in the treatment gram may be used in the following spores/day in tablet form) were of acute and selected food products: studied in 17 patients with type chronic diarrhea Baked Goods, Breakfast Cereals, Other II hyperlipidemia in an open was investigated Grains, Fats & Oils, Milk Products, Cheese, label fixed dose trial (5). Total (7). Eligible Frozen Dairy, Soft Candy, Confectionery & serum cholesterol (330 mg/dl patients were Frosting, Gelatins & Puddings, Soups, vs. 226 mg/dl), LDL-cholesterol randomly Snack Foods, Non-alcoholic Beverages, (267 mg/dl vs. 173 mg/dl) and allocated to two Imitation Dairy Products, Hard Candy, total cholesterol to HDL groups. There Sugar Substitutes and Instant Coffee & Tea. cholesterol and LDL-cholesterol were 103 patients to HDL-cholesterol ratios were in the study group reason 4 – documented clinical reduced significantly over a (51 with acute effectiveness period of three months. HDL- diarrhea and 52 Clinical Study 1: Gastrointestinal Health cholesterol was marginally Figure 2 – Clinical study 3: Serum with chronic (Japan) increased (43.6 mg/dl vs. lipid profile (India). diarrhea) and 101 In this double-blind, randomized clinical in the control study, a total of 567 subjects participated group (51 with in 19 independent health care institutions. acute diarrhea Duration of study was 2-20 days and and 50 with dosage of probiotic was 50 million to 750 chronic million CFU/day (3). As a result of diarrhea). The receiving B. coagulans, 93.7% of diarrhea study group due to acute or chronic gastroenteritis, received 85.9% of maldigestion accompanied with B. coagulans Table II – Clinical study 5: Acute and chronic diarrhea (China). 20 MARCH/APRIL 2012 PREBIOTICS / PROBIOTICS tablets at a dose of 10 8 CFU, three times Colitis), and inhibition of intestinal Payson, UT, United States. daily for 3-7 days (acute diarrhea) and 14- bacterial enzymes involved in the – Second Service – ClinWorld Contract 21 days (chronic diarrhea), while the synthesis of colonic carcinogen. Research Organization (CRO): ClinWorld control group received Golden Bifid – Non-GI tract conditions – urinary tract conducts clinical trials according to Good (Bifidobacterium longium ) tablets at a infections, non-specific vaginitis, Clinical Practice, GCP – randomized, dose of 10 8 CFU three times daily for 3-7 hyperlipidimia and double-blind and placebo-controlled. days and 14-21 days. hypercholesterolemia, hypertension, ClinWorld’s scope of services is from Administration of these probiotic and respiratory tract infections. trial design and protocol development preparations was randomized and double- to writing final report and helping with blind. The results showed that reason 6 – availability of Matching claim substantiation. ClinWorld has – The best effectiveness
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