Author Archives: Sanzyme Biologics

Probiotics are made of good live bacteria and/or yeasts that naturally live in our body. These helpful microbes exert beneficial effects on host health by creating microbial balance in the digestive system. A variety of good bacteria has been explored to improve general health and well-being of humans and animals.

In probiotics Bacillus coagulans, a spore-forming microorganism, is one of the most promising candidate since it meets all the criteria to be considered as probiotic in human and animal feed industry:

(1) survive the passage through the gastrointestinal tract, acid and bile resistant.

(2) adhere to intestinal epithelial cells

(3) grow fast, colonize the intestinal tract, and then leave the body

(4) stabilize the intestinal microflora

(5) no signs of pathogenicity

(6) maintain viability both in food and drugs.

In the spore form, it is resistant to gastric fluid and bile and cannot be lysed during manufacturing processes and storage. In the duodenum, the spores of B. coagulans can germinate into vegetative bacteria showing probiotic activity and later excreted from the body without alteration of the individual human microflora’s composition.  B. coagulans is not merely a component for dietary supplements but a number of drugs containing this bacterium have entered the global pharmaceutical market and have already proven their clinical efficacy. The probiotic is available in capsules and sachets, as well as in functional foods and dietary supplements in a dormant, spore-like state until they get activated in the intestines.  Thus the B. coagulans bacterium can be called ‘the king of probiotics’ due to its high stability in the gastrointestinal tract, non-toxic action, and pharmacological activity.

The spores of B. coagulans are present in various natural food sources. The consumption of vegetative cells and spores of Bacillus spp. by human beings is frequent through fermented foods and raw vegetables. A diverse range of Bacillus species are found to be associated to the natural fermentation of soy, locust bean, maize, rice and many more substrates. For example, Natto (Japan), Gari (Africa) TapaiUbi (Malaysia), Douchi (China), Soibum (India), Ugba (Nigeria) etc. are among the popular functional foods naturally harboring the blend of Bacillus spp. and LAB. The palatability and health promoting characteristic of these locally produced supplements has also attracted the attention of global market. A diverse range of LAB and Bacillus spp. isolated from such indigenous foods has been studied and are being used for the commercial preparations of functional products.

The mechanisms by which spore forming probiotics could enhance health of the host include stimulation of immune system, synthesis of different antimicrobials, like bacteriocins, enzymes and modulation of the composition of gut microbiota. The mechanism behind establishment of gut homeostasis involves promotion of growth of other beneficial microbes and suppression of pathogen and pathogen induced inflammatory response of intestinal mucosa. The efficacy of beneficial probiotics is attributed to their tolerance to stress factors while most probiotics have a relatively short and unstable shelf life. The most important aspect of Bacillus coagulans is that it generates spores and imparts several health benefits of non-spore forming probiotics along with its ability to tolerate heat and stressful requirements of food processing as well as gastrointestinal tract conditions. Their success has led to the development and marketing of a broad range of products thus a promising potential in production of probiotic foods.

B. coagulans for human diseases:

The administration of B. coagulans can be considered as a preventive and/or therapeutic approach for human diseases. A variety of bacteria and enzymes exists within our gut. Choosing the right type of probiotics will help cultivate and maintain sustainable balance that encourages overall wellness. Bacillus coagulans helps the gut by providing lactic acid to the digestive system. Lactic acid helps regulate healthy pH levels to encourage a balanced environment and inhibit the growth of bad bacteria. B. coagulans can promote intestinal digestion. For example, B. coagulans strains can produce various enzymes that facilitate excretion and digestion. B. coagulans can regulate host symbiotic microbiota and inhibit the growth of pathogenic bacteria. By its ability to act on immune system, B. coagulans can significantly benefit the host immune system.

Host microbiota plays an important role in maintaining human health. Many diseases have been associated with an imbalance of the microbiota, whereas restoration of the microbiota has been demonstrated to maintain health and treat disease. Thus B. coagulans has the ablity to influence the diversity, composition and metabolic function of the intestinal and vaginal microbiota. coagulans has a proven safety record. B. coagulanshas been granted Generally Recognized As Safe (GRAS) status by the US Food and Drug Administration (FDA) due to the evidence supporting various probiotic effects of B. coagulans. EFSA has included B. coagulans in QPS list. Also, several in vitro and in vivo studies were performed to examine the toxicity of B. coagulans and no adverse effects are reported.

a) Effect on Digestive Health:

Digestive disorders can cause diarrhea, gas, bloating, irritation, and other concerns that directly affect quality of life. Bacillus coagulans helped relieve bloating and discomfort caused by digestive ailments and seems to alleviate gas and abdominal discomfort in otherwise healthy adults. Bacillus coagulans is a beneficial probiotic strain that helps to promote digestive health by encouraging a healthy immune system, normalize nutrient absorption in the body, and help balance gut flora. Similar to the Lactobacillus bacterium, Bacillus coagulans produces lactic acid inside the digestive tract.

Lactic acid is helpful in encouraging the growth of healthy bacteria while inhibiting the growth of harmful bacteria. Although B. coagulans can only temporarily reside in the intestine but it can significantly modulate the gut microbiota by increasing the number of beneficial microorganisms and antagonizing pathogenic microorganisms. B. coagulans has been reported to have a good regulatory effect on dysbacteriosis caused by various factors. Over 20% of people who take antibiotics experience antibiotic-associated diarrhea and Bacillus coagulans may be an effective remedy.

Consumption of B. coagulans helps:

• to increase populations of good bacteria including Lactobacillus and Bifido bacteria in the gut.
• coagulans can competitively outcompete several opportunistic pathogens, such as vancomycin-resistant enterococci and Escherichia coli, thereby maintaining homeostasis with the intestinal microbiota.
• coagulans create an anaerobic and acidic intestinal environment, which is not hospitable to various pathogens, thereby promoting the growth of healthy microflora.
• As facultative anaerobic bacteria, coagulans strains can consume free oxygen in the intestine thereby beneficial to the growth of anaerobic microorganisms such as Lactobacillus and Bifidobacterium.

Therapeutic benefits of B. coagulans may be related to its ability to produce antimicrobial compounds, thereby hindering pathogenic bacterial growth and balancing microbiota populations. B. coagulans strains secrete bacteriocin, a well-known antibacterial substance.  The mechanism of action of bacteriocins relates to their ability to penetrate the surface of pathogenic bacteria, thereby inhibiting growth. In addition to bacteriocins, B. coagulans can also secrete other antimicrobial substances such as lactic acid and acetic acid.

Lactic acid is an important antimicrobial substance produced by B. coagulans in the human gut. Many in vitro studies have focused on the lactic acid fermentation characteristics of B. coagulans and demonstrated that B. coagulans can utilize various carbon sources to produce lactic acid in anaerobic conditions at temperatures under 50 °C, indicating the possibility that B. coagulans can produce lactic acid and its derivatives in the human GIT. In addition to its antimicrobial properties, lactic acid and its derivatives have also been shown to accelerate intestinal stem cell-mediated epithelial development in rats. Therefore, considering the high yield of lactic acid, B. coagulans may possess the ability to promote gut epithelial development and repair.

A recent study of Sanzyme Biologics, Bacillus coagulans SNZ 1969 strain was conducted on healthy subjects with mild intermittent constipation, supplemented with B. coagulans SNZ 1969 (BC) or the placebo for 8 weeks (n = 80). The results indicated that B. coagulans SNZ 1969, a spore-forming probiotic strain, reaches the colon intact and ameliorates intestinal motility and gut microbiota composition compared with the placebo group.

(  DOI: https://doi.org/10.1016/j.foodres.2021.110428)

Another study with SNZ 1969 strain was recently published to evaluate the efficacy and safety of SNZ 1969 in individuals with GI discomfort. The results show that SNZ 1969 was found to be safe and effective in reducing GI discomfort, especially dyspepsia. Bacillus coagulans SNZ 1969 is an effective and safe option for relieving symptoms of abdominal discomfort, especially dyspepsia, in otherwise healthy individuals. It showed an improvement in total SODA scores, including specific symptoms such as burping/belching, bloating, heartburn, passing gas, nausea, bad breath, and sour taste compared with placebo.

( DOI: https://doi.org/10.52403/ijhsr.20220336 )

b) Effect on vaginal health:

Bacterial vaginosis is the most common vaginal infection worldwide, characterized by reduced lactic acid bacteria in the vaginal environment. The vaginal microbiome is dominated by Lactobacillus in healthy women. However, some pathogenic strains, such as Gardnerella, Mobiluncus and Atopobium can alter the balance of the vaginal flora, leading to bacterial vaginosis (BV).

Bacterial vaginosis (BV) has been reported in one-third of women worldwide at different life stages, due to the complex balance in the ecology of the vaginal microbiota. Bacterial vaginosis (BV) can occur when there is an imbalance in the vaginal microbiome (i.e., reduction in Lactobacillus spp. abundance) and overgrowth of certain microbial populations(s) in the vagina leading to vaginal discharge with a foul odor. BV-affected women may also encounter itch/burning sensation and discomfort around the intimate area. Antibacterial therapy is often ineffective in the treatment of the disease. B. coagulans can alleviate the symptoms of non-specific vaginitis.

The study aimed to evaluate the efficacy of Bacillus coagulans (SNZ-1969) against BV and the ability of this bacterial species to prevent BV recurrence in women aged 18–41 years was conducted. The study assessed 173 women, and of these women, 120 showed recurrent BV according to Nugent’s and Amsel’s criteria. These 120 women were randomly assigned to the following study arms: metronidazole arm and metronidazole + B. coagulans arm. The metronidazole + B. coagulans arm showed better success (86.6%) in treating and minimizing recurrence of vaginal infections. Oral supplementation with probiotics can be an efficient approach for the treatment of BV.

c) Effect on oral health

Oral microbiome is a complex ecological system. The oral microbial community develops with competition as well as synergy among the hundreds of species present in the oral cavity. Bacterial populations in the human oral cavity are constantly in a dynamic state of change. Oral microflora can cause dental plaques and are also a common cause of dental caries and periodontal disease. Various species of pathogenic bacteria known to present in oral cavity includes Streptococcus sps, Staphylococcus, Pseudomonas etc.

Probiotic consumption is reported to exert a myriad of beneficial effects in oral health. Many clinical studies are conducted to see the effect of B. coagulans SNZ 1969. The use of SNZ 1969 probiotic mouth rinses improves the oral health in children by significantly reducing the plaque and gingival scores. Treatment using probiotic B. coagulans SNZ 1969 resulted in reduction of cariogenic microorganisms.  Thus Bacillus coagulans  shows an economically viable probiotic for maintaining oral health.

d) Effect on host immune system

A growing body of evidence suggests that probiotics play an important role in maintaining human immunologic homeostasis. In recent years, B. coagulans has attracted great interest in this field due to its strong modulatory effects on host microbiota and immune responses with almost no safety concerns. Bacillus coagulans influences the body’s immune response by providing general support for all beneficial probiotic strains. A strong, robust community of bacteria in the gut help promote normal immune system health.

e) coagulans in functional foods:

Lactic acid bacteria (LAB; for example, Lactobacillus and Bifidobacterium and some Saccharomyces species) are the microorganisms most commonly used in probiotic food production. However, these microorganisms cannot survive heat treatment. Heat treatment is not applicable for most probiotic foods that contain commercial probiotic microorganisms due to their sensitivity to heat. It has been stated that this restriction could be overcome by the usage of spore-forming probiotic microorganisms. The survival and stability of these bacteria have considerably better compared to others through their spore-forming abilities.

They are identified as an ideal choice for development of functional foods by protecting their vitality in high-temperature applications. Interest in probiotic fortified functional foods and beverages continues to grow across countries. Exhibiting the characteristics of both Lactobacillus and Bacillus genera, Bacillus coagulans has attracted the attention of many food manufacturers and researchers for its use in the food industry. Cost-effectiveness and better stability and survival of Bacillus coagulans in high-temperature, heat treated food products are the major factors fostering the adoption rate of Bacillus coagulans in the food and beverages industry. Bacillus coagulans is being increasingly used in food supplements to strengthen the immune system, provide anti-allergy effect, and reduce gastrointestinal system infection.

Food supplements containing Bacillus coagulans has been shown to have a number of positive benefits –

• It can help digestion in the intestine and generate a variety of enzymes that aid in excretion.
• It can control the symbiotic microbiota in the host and prevent harmful bacteria from growing.
• It can significantly improve the host immune system.
• coagulans strains have been investigated in treating and relieving numerous human illnesses.

Thus administering B. coagulans might be a promising preventative therapeutic strategy for human illnesses. Bacillus coagulans have emerged as a trending probiotic which acts as a promising agent for modulation of diseases.

Sanzyme Biologics has been manufacturing Bacillus coagulans for more than 5 decades and a pioneer in the Domestic and International Markets. The strain Bacillus coagulans SNZ 1969 has received following certifications and approvals.

About Sanzyme Biologics:

Sanzyme Biologics was incorporated in 1969 as Uni-Sankyo, the first ever Indo Japanese joint venture in the healthcare industry. This was the first-generation biotechnology company in India which brought the concept of making enzyme and probiotics through fermentation technology. Over the last five decades Sanzyme Biologics established its strength in probiotics by developing special probiotic strains with in-house expertise, pioneered their applications beyond human health into aqua, veterinary, poultry and bioremediation, which are sold around the world.

Today, Sanzyme Biologics works with reputed companies to meet ingredient requirements in  food, supplement, pharmaceutical and animal health segment.

Probiotics are available in various forms of functional foods and dietary supplements for human use. The most commonly sold carriers of probiotic bacteria are Dairy products, beverages, health drinks etc. Furthermore, capsules and tablets containing lyophilized or spray dried probiotic bacteria are available in health food stores.

The concept of probiotics rose about more than one hundred years ago. Döderlein and, later Metchnikoff proposed that bacteria producing lactic acid from sugars should have some beneficial effects on the hosts. Although known since a long time, only in the last two decades probiotics have started to receive major attention from researchers, and several studies have been carried out on the effects of probiotics microorganisms, in different combinations for the purposes of preventing or treating diseases. They are commonly considered as viable microorganisms that beneficially affect the host health when ingested. The microorganisms most frequently used as probiotic agents are majorly from the genus Bacillus, Lactobacillus, Bifidobacteria and yeasts. Success of probiotics has led to development and marketing of a broad range of products based on probiotics.

Probiotics which are originally defined as microorganisms promoting the growth of other microorganisms, the definition of probiotics has been revised and changed several times based on their effects on individuals. Probiotics are considered as those viable microorganisms that when administered to man and animal, beneficially affects the host by improving the properties of the indigenous microflora. More recently probiotics have been defined as mono- or mixed cultures of “live microorganisms which, when administered in adequate amounts, confer a health benefit on the host” (FAO/WHO, 2002).

There are two basic forms of probiotic microorganisms used in foods: the vegetative form and the spore form. The vegetative form is more susceptible to low pH conditions in the stomach, bile salts, pancreatic juice, high temperatures, moisture, acidity, shelf life of food, and negative environmental conditions during the manufacture of food than the spore form. Fermentation conditions, freezing, thawing, drying, cell protection additives, rehydration of dried probiotics, and microencapsulation applications are factors that affect the survival of probiotic microorganisms during probiotic food production. The survival and stability of spore forming bacteria is considerably high compared to vegetative forms due to tough spore coat. Probiotic spores thus offer flexibility for incorporation in a variety of formulations, process conditions such as heating and handling without a need for cold chain. Bacillus-containing foods and feeds are used as food supplements for humans, growth enhancers for animals, and growth regulators or protectors against diseases in aquaculture. It is reported that regular consumption of probiotic microorganism-containing products strengthens the immune system, exhibits an anti-allergy effect, reduces cancer risk, lowers cholesterol, prevents digestive problems, and reduces gastrointestinal system infections. The lactic acid bacteria have received major considerations in regard to food and nutrition.

Lactobacillus sporogenes (L. sporogenes) vs B. coagulans: What name to prefer?

Bacillus coagulans is a lactic acid–forming bacterial species first isolated and described in 1915 by B.W. Hammer at the Iowa Agricultural Experiment Station as a cause of an outbreak of coagulation in evaporated milk packed by an Iowa condensary. In 1932, Horowitz and Wlassowa named it as Lactobacillus sporogenes. Separately isolated in 1935 and described as Lactobacillus sporogenes in the fifth edition of Bergey’s Manual of Systematic Bacteriology. By the Seventh Edition of Bergey’s Manual in 1957, the bacterium was reclassified in the Bacillus genus and the correct nomenclature is Bacillus coagulans (B. coagulans). The bacterium may still occasionally be erroneously referred to as L. sporogenes.

By definition, lactic acid bacteria (Lactobacillus, Bifidobacterium) do not form spores. Although B. coagulans does produce L+ lactic acid, Bacillus species do not belong to the lactic acid bacteria. But B. coagulans exhibits characteristics typical of both genera Lactobacillus and Bacillus, its taxonomic position between the families Lactobacillaceae and Bacillaceae was often debated. Determination of the taxonomy of bacterial species is a key point, since it is well known that different species belonging to the same genus may have different beneficial properties. From this point of view, Lactobacillus sporogenes, or, as it should be correctly classified, Bacillus coagulans, represents the misidentified probiotic and its listing among probiotics has often been matter of debate. However, in the seventh edition of Bergey’s, it was finally transferred to the genus Bacillus. Therefore, using the name Lactobacillus sporogenes is scientifically incorrect.

It was observed that several publications and in many product descriptions provided by manufacturers of products with this bacterium, it is stated that B. coagulans is not a proper Bacillus and has some characteristics in common with the genus Lactobacillus. Considering the characteristics of the species it can be stated that it indeed bears characteristics of both genera. There are as many arguments to place the species in Lactobacillus as in Bacillus. There is, however, no conclusive argument to place the strain under Lactobacillus, whereas the spore-forming capacity definitely places the strain within the genus Bacillus. By definition, the genus Lactobacillus does not form any spores, which makes it impossible to name the strain Lactobacillus. As there are many bacteria that make lactic acid, the fact that it produces lactic acid is not conclusive to place the strain in the genus Lactobacillus. At the same time B. coagulans differs from the other bacteria of the genus Bacillus for position of terminal endospore in the cellular body while in other bacilli they are located centrally or subterminally, lack of cytochrome-c oxidase and for the incapability to reduce nitrate to nitrite. The designation ‘spore forming Lactobacillus’ is definitely incorrect, as by definition Lactobacillus species do not form spores and, as stated above, this may be confusing.
Concluding, the name Lactobacillus sporogenes has no scientific or legal status and thus does not ‘exist’ scientifically and therefore should not be used on product labels. The official name is Bacillus coagulans.

Lactobacillus vs Bacillus:

Lactic acid bacteria (LAB; for example, Lactobacillus and Bifidobacterium) and some Saccharomyces species are the microorganisms most commonly used in probiotic food production. A large number of scientific reports have focused on these probiotic species, investigating various aspects such as industrial applications, therapeutic properties and biosafety. Lactobacilli and bifidobacteria are sensitive to physiological conditions such as pH of the stomach and bile salts.

The bioavailability of these bacteria is also affected by various conditions of production, storage and transportation. These microorganisms cannot survive heat treatment. Heat treatment is not applicable for most probiotic foods that contain commercial vegetative probiotic microorganisms due to their sensitivity to heat. Various factors during food production like food additives, oxygen content, moisture content/water activity, storage temperature, pH and titration acidity, and packaging conditions affect survival of probiotic microorganisms during storage. As stated earlier, gastrointestinal system conditions like gastric acid and bile could cause significant loss of viable probiotic cells. Thus these restriction could be overcome by the usage of spore-forming probiotic microorganisms.

Use of spore-forming bacillus bacteria includes advantages compared to that use of lactobacilli does because products containing these bacteria can be preserved in dry forms at room temperature without any negative effects on the survival of spores. Another advantage of using spores is linked to their ability to tolerate low pH and successfully passing the GIT. Bacterial spores include a greater resistance to thermal lethal effects, drying, freezing, toxic chemicals and radiation compared to that vegetative cells do. In recent years, a number of Bacillus species. have been reported as novel probiotics.

Spore-forming bacilli have been used for many years for food production and preservation. The importance of bacilli bacteria in food chains is associated to their innate production of an extensive number of enzymes, vitamins, antimicrobials and protein compounds as well as organic pigments such as carotenoids. Nowadays, Bacillus species is becoming popular in human health and functional food research primarily due to their enhanced tolerance and survivability under the antagonistic environment of GIT. Furthermore, stability of Bacillus microflora during food processing and storage makes them ideally functional candidates for health boosting formulations.

Bacillus coagulans: General facts

B. coagulans is a gram-positive, facultative anaerobic, nonpathogenic, spore-forming, lactic acid-producing bacteria. It is resistant to heat. The optimum growth temperature for B. coagulans is 35 to 50oC and the optimum growth pH is 5.5 to 6.5. It has the characteristics of microorganisms used as probiotics. Although B. coagulans produces acid, it does not produce gas from maltose, raffinose, mannitol, and sucrose fermentation. In addition to lactic acid production, some strains also produce thermostable α-amylase. For this reason, B. coagulans is important from an industrial point of view. B. coagulans has been reported as safe by the US Food and Drug Administration (FDA) and the European Union Food Safety Authority (EFSA) and is on the Generally Recognized As Safe (GRAS) and Qualified Presumption of Safety (QPS) list

B. coagulans SNZ 1969: Strain information

Bacillus coagulans is a proven probiotic in supporting digestive and immune health and well accepted in food & beverages as a probiotic supplement. B. coagulans designated as strain SNZ 1969 is marketed in India under the brand name “SPORLAC” and has been used as probiotics for about 50 years. Thus, it can be said that all studies conducted in India prior to 1990 likely used our strain (in cases where it is not mentioned) and all studies citing SPORLAC should be considered studies on SNZ 1969 only.
Sporlac has an exceptional safety record with more than five decades in the Indian Pharmaceutical Market. The product has been used extensively in the pediatrics segment and has an unmatched safety record with no significant adverse effect reported or recorded. The strain SNZ 1969 contained in Sporlac, has FDA GRAS status from the United States FDA and Heath Canada approval from NNHPD for its use as an ingredient.

Sanzyme Biologics has been manufacturing Bacillus coagulans for more than 5 decades and a pioneer in the Domestic and International Markets. The strain has received certification following certifications and approvals,

 

B. coagulans SNZ 1969: Deposit in culture collection of microorganisms:

The strain of Bacillus coagulans SNZ 1969 has been deposited in three recognized culture banks:
• At the Microbial Type Culture Collection and Gene Bank of India (MTCC) registered under the code MTCC 5724 recognized as an International Depositary Authority under the Budapest treaty.
• In the Belgium Microorganism Collection (BCCM), under the code BCCM LMG S-27484, also recognized by the World Intellectual Property Organization (WIPO) as an International Depositary Authority (IDA).
• As well as in the American Type Culture Collection (ATCC) under code 3560.

B. coagulans SNZ 1969: Historical perspective

The B. coagulans strain was isolated from green malt in 1949 by a Japanese physician, Dr. Nakayama. The strain was identified in 1951 by Nakayama and colleagues as Bacillus coagulans Hammer (Nakayama et al., 1951).

This strain was launched as B. coagulans SANK 70258 spores preparation by Sankyo Co., Ltd. (currently known as Daiichi Sankyo Co. Ltd.) in Japan under the trade name LACBON in 1964.
In 1973, the Sankyo Corporation offered the formulation and fermentation technology of the B. coagulans strain to Sanzyme Ltd; the strain was then designated strain SNZ I969 and was used to manufacture spores preparation marketed under the trade name Sporlac® in India (Sanzyme, Ltd, 2015). B. coagulans SANK 70258 is therefore the mother strain of SNZ 1969, a strain used in a spores preparation and recently determined to be GRAS for use in select foods (Sanzyme, Ltd, 2015, GRN 597). Since then, B. coagulans designated as strain SNZ 1969 is marketed in India under the brand name “SPORLAC” and has been used as probiotics for about 50 years.

About Sanzyme Biologics:

Sanzyme Biologics was incorporated in 1969 as Uni-Sankyo, the first ever Indo Japanese joint venture in the healthcare industry. This was the first generation biotechnology company in India which brought the concept of making enzyme and probiotics through fermentation technology. Over the last five decades Sanzyme Biologics established its strength in probiotics by developing special probiotic strains with in-house expertise, pioneered their applications beyond human health into aqua, veterinary, poultry and bioremediation, which are sold around the world.
Today, Sanzyme Biologics works with reputed companies in over 3 countries to meet ingredient requirements in biotech space in the pharmaceutical, food, supplement and animal health segment