Bacillus coagulans is a rod-shaped, slightly acidophilic, gram-positive, catalase-positive, spore forming, thermotolerant, aerobic to microaerophilic, highly resilient bacteria. Many strains of Bacillus coagulans were isolated and studied for their probiotic benefits in the last few decades It was originally isolated and described in 1932 by Horowitz and Wlassowa and named lactobacillus sporogenes. In 1957, the organism was reclassified in Bergey’s Manual of Determinative Bacteriology based on its biochemical properties, and the current correct nomenclature is Bacillus coagulans Bacillus coagulans are hardy, spore-forming bacteria that act as vegetative bacteria when conditions are optimal for their growth but can also form dormant spores when conditions are detrimental to their viability. Think of this spore like a plant seed—it is dormant and won’t grow until there is the right temperature, moisture and food source. Research on specific Bacillus strains has shown they can withstand both heat and acidic conditions, and these spores are much more resistant to the extremes of pH, heat, cold and pressure than vegetative cells. This makes them a much better fit for fortification in everyday foods and beverages, including products that may be hot, cold or frozen, shelf-stable or subject to extreme manufacturing processes.
Bacillus coagulans can survive in most applications without the need for refrigeration by staying dormant until they reach the digestive tract. Bacillus coagulans shielded by natural capsules called spore. It can sustain hostile gastric and bile acids in human gut and remains stable in highly acidic (pH 2) environment. It is also resistant to high temperature i.e. up to 85°C for 30 min. From production to consumption, it does not show decrement in viability of cell.
Bacillus coagulans is a transient colonizing probiotic, meaning it takes up only temporary residence in the intestines. Spores of Bacillus coagulans are excreted slowly via the feces for approximately a week after supplementation is stopped. This transient nature prevents any unwanted potential for overgrowth of Bacillus coagulans within the gastrointestinal tract.
|Vegetative cells||Rods, occurring singly, rarely in short chains, variable in filaments by cultural conditions|
|Size||0.9 by 3.0 to 5.0 Microns|
|Endospore||Spore former, oval and terminal position Present after 48 hours of incubation at 37oC|
|Shape||Ellipsoidal 0.9 to 1.2 by 1.0 to 1.7 microns terminal, occurring singly|
|Optimal temperature||50oC; Range of temp. tolerated – 30 to 55oC|
|Reaction to stain||Gram stain – Positive Spore staining – Spores stain red and vegetative cells stains blue|
|Surface col. on solid med||Smooth circular colony with entire edge in PNY medium|
|Growth in simulated intestinal fluid||Growth is abundant in (PNY broth with NaHCO3 0.15%, Pancreatin 0.25%, pH 7.23, incubation for 24 hours at 37oC)|
|Litmus milk||pH 4.4 – 4.6|
|Production of indole||Not produced|
|Production of hydrogen sulphide||Not produced|
|Voges proskauer test Acetyl methanol Carbinol||Not produced|
|Lactic acid production||Positive|
The gastrointestinal life cycle of Bacillus coagulans in humans
The ability to generate spores is a unique feature of Bacillus probiotics, and improves their survival rate in the harsh environment of the GIT (Gastrointestinal tract). Bacillus coagulans has attracted considerable attention due to its ability to produce spores. Researchers have elucidated the mechanism of formation and structure of the spores of Bacillus coagulans and demonstrated that it sporulates in harsh conditions (e.g. nutrient limitation, heat, moisture, temperature etc.) and with the help of quorum sensing signals it starts germination through a complex developmental process. After the sporulation process, the structure of the spores of B. coagulans is distinctly different from the vegetative cells. Spores of Bacillus strains can survive for years in their dormant state, but if given the proper stimulus, they can rapidly germinate. Typically, in an adult, the first phase will take approximately three hours where Bacillus coagulans spores get into the body orally and safely transit across through the stomach. In stage 2, after passing through the stomach, the spores begin to germinate in the duodenum and proliferate in the upper part of the small intestine. A nutrient-rich environment with low microbial stress is a major factor in spore germination. Usually, the residence time of Bacillus coagulans in the small intestine ranges from two to three hours. Lastly, in stage 3, live Bacillus coagulans will travel down to the large intestine and sporulate in the lower part of the colon. The chance of germination in the large intestine is very low due to the nutrient-deficient environment and the increased sensitivity of vegetative cells in the exponential phase. Traditional probiotics, such as Lactobacillus and Bifidobacterium species, show outstanding probiotic activities, but their survival is generally low, in the order of 1–15%, with some strains performing even more poorly. Therefore, spore-forming probiotic microorganisms have attracted the interest of researchers and marketers.
Bacillus coagulans benefits are strain specific
Strain differences are critical and requires a great deal of attention while dealing with probiotics. There are many strains of Bacillus coagulans identified, isolated and studied for their efficacy but they are all unique in their own way. This means efficacy, safety and clinical studies from one strain cannot be used to support the safety and efficacy of another. There are also key differences in the levels of probiotic performance such as stability and applications into various formulations such as food, supplement or pharmaceuticals product. When choosing a probiotic strain, it is important to do your research and ensure that the probiotic is safe, backed by scientific publications covering the benefits of your interest. Additionally it should be supported with stability data such as in gastrointestinal tract and various application matrix.
Bacillus coagulans SNZ 1969® is unique in the space of spore forming probiotic strains. It boasts an exceptional history of use, stability profile, research and genetic pedigree. Combined with Sanzyme’s experience in end-to-end production and decades of continuous technological improvement, SNZ 1969™ is a reliable, long-term choice for inclusion in probiotic formulations in supplements, food, and pharmaceuticals.
Bacillus coagulans SNZ 1969® strain has been deposited with the Microbial Type Culture Collection (MTCC) -assigned number MTCC 5724 and with Belgian Coordinated Collections of Microorganism (BCCM™ILGM) with the assigned number LMG S -27484. It was first isolated from green malt in 1949 by a Japanese physician, Dr. O. Nakayama (Nakayama 1950). The strain was tested for its potential effects against diarrhea and constipation in adult as well as infants during the 1960s (Mashita 1964; Nakayama 1966). In 1972, at the request of Sankyo Corporation, the Japanese Ministry of Health and Welfare approved the use of Bacillus coagulans (designated as strain SANK 70258) as a therapeutic probiotic. Subsequently, in 1973, Sankyo Corporation (currently known as Daiichi Sankyo Co. Ltd) offered formulation and fermentation technology to Sanzyme (earlier known as Uni-Sankyo Ltd). Since then SNZ 1969 has been marketed in India under the brand name “SPORLAC” and has been used as a therapeutic probiotic for about 50 years. More recently, SNZ 1969 is being marketed as a probiotic strain for use in foods, supplements and pharmaceutical formulations in various countries across the globe depending on the local requirements.
STABILITY of Bacillus coagulans SNZ 1969®
A probiotic to be effective it should stay stable until it reaches the target site in the gastrointestinal tract. Following are the challenges a live probiotic organism undergoes until this process,
- Storage and handling until processing
- Processing conditions such as heat, pressure etc.
- Food composition and conditions such as pH and presence of other antimicrobial constituents
- Shelf life and handling until consumption.
- Acidic conditions in the stomach, pH can be below 2
- Bile acids which tend to impact probiotic viability
Bacillus coagulans SNZ 1969® has the key to these challenges. Bacillus coagulans SNZ 1969® is an aerobic, spore forming, lactic acid probiotic bacteria which has superior stability as compared to the traditional vegetative organisms available in the market. This unique quality makes it the best probiotic option from the stability perspective.
SAFETY of Bacillus coagulans SNZ 1969®
Bacillus coagulans SNZ 1969® is one of the oldest and most widely used strains of Bacillus coagulans worldwide. Sanzyme has been selling the SNZ 1969® strain in the Indian market since 1973, under the brand name “SPORLAC®”; initially focusing on the infant and neonate segment and now more recently prescribed for treatment of various symptoms of gut discomfort. Over 130 million dosses prescribed and consumed annually. A whole genome sequence of SNZ 1969® was conducted to identify any potential virulence or enterotoxin genes (Heikkinen 2017). It was determined that SNZ 1969® has no genes encoding known virulence determinants. Additionally, several attempts were made to extract plasmid DNA, but none were found, leading to the conclusion that plasmids are not present in this strain. In-vivo research has corroborated this finding. An analysis of the safety of SNZ 1969® in animal models indicates that there is no evidence to suggest it causes mutagenicity or genotoxicity in several commonly utilized genetic toxicity assays. Acute oral toxicity studies were performed using a concentration of 1.2 million CFU/g with no observed adverse effects. A single oral dose of 5,000 mg/kg body weight was orally administered by gavage to Wistar rats of either sex (as per OECD and USFDA guidelines). No mortality, adverse clinical signs or weight loss was observed during the 14 day study period. Based on this study the No Observable Effect Level (NOEL) of B. coagulans is > 5000 mg/kg body weight. (see FDS GRAS document GRN 597). Both the B. coagulans “type strain” and the SNZ 1969® strain have been fully sequenced (Khatri 2016; Heikkinen 2017). The complete genome sequence of B. coagulans SNZ 1969® has been deposited in GenBank under the accession number CP011939. Based upon these genomic and toxicological assessments and its long history of use, SNZ 1969® is considered safe for chronic human consumption and has received United States FDA Generally Recognized as Safe (GRAS) status including Infant GRAS.
SNZ 1969® is of Non-GMO origin and is produced in a GMP, FMIQS and NSF certified facility.
EFFICACY of Bacillus coagulans SNZ 1969®
Bacillus coagulans SNZ 1969® is supported by twenty plus scientific publications covering gut health, Immunity against GI tract pathogens, inhibition of food borne pathogens, inhibition of bacteria causing dental carries & gingivitis and bacterial vaginosis.
a. Gut health, Immunity against GI tract pathogens & Inhibition of food borne pathogens
Studies cover neonates, pediatrics and adult population in India. Most of them are independently published, peer reviewed placebo controlled. Condition studied include diarrhea, rotaviral diarrhea, gastroenteritis, gas and bloating. List of studied “Food borne pathogens” with clear zone of inhibition include Escherichia coli, Pseudomonas, B. cereus, Salmonella, Staphylococcus aureus.
A prospective double-blind randomized study conducted by GI Chandra has shown that feeding Bacillus coagulans (SPORLAC) on a prophylactic basis in the first year of life has a significant preventive impact on the incidence and duration of diarrhea as well as the total number of days of illness. This 12-month long study concludes a reduction in the number of illness days among treatment group down to 13 from 35 days in the placebo group reiterating immunity or natural defense against GI pathogens such as rotavirus. Studies conducted by Dhongade, R.K et al, Deodhar, J et al, Dr Balabhai Nanavati and Mukesh Choudhary et al also concludes the role of Bacillus coagulans SNZ 1969 in the GI health.
b. Inhibition of oral pathogens causing dental carries & gingivitis
Oral studies include Indian children of age group 7 to 14 and adults of 20 – 30 years. These studies have shown the inhibitory effect of Bacillus coagulans SNZ 1969 on the cariogenic bacteria streptococcus mutans and parameters of gingivitis. A study by A Jindal et al concludes the administration of Bacillus coagulans (SPORLAC) in a group of Indian children resulted in a significant reduction of a cariogenic microorganism, Streptococci mutans. With an increasing global problem of antibiotic resistance, contributing to preventing the effective treatment of microbial diseases, probiotic by virtue of their natural therapy appear to be a novel approach for carries prevention. Dietary supplementation of probiotics might be used as a suitable, easy safe method for carries prevention. Study by Purnima Vidyesh Nadkerny et al concludes that probiotics offer a natural and promising option to establish both a good oral and systemic health. The probiotic mouth rinse tested with Bacillus coagulans (SPORLAC) was effective in reducing plaque accumulation and gingival inflammation. Oral probiotics represents a breakthrough approach to maintain oral health by utilizing natural beneficial bacteria to provide a natural defense against those bacteria thought to be harmful to teeth and gums.
c. Inhibition of pathogens causing bacterial vaginosis