2020 - Sanzymebiologics

Probiotics And Vaginal Health

In the last decade, many clinical trials have been conducted to assess the effects of probiotics in the prevention and treatment of a broad range of disorders, and the scientific interest in this field is growing. The rationale of using oral probiotics in the treatment of gynaecological conditions is related to the ability of these microorganisms to survive through the gastrointestinal system and to ascend to the vaginal tract after their excretion from the rectum; whereas vaginal administration allows a direct and targeted colonization action of the probiotics for restoring healthy vaginal microbiota.¹

Probiotics in Non-Pregnant Women

Vaginal infections represent one of the most common reason for gynaecological consultation.

Bacterial vaginosis is the most common type of vaginal infection among women of reproductive age and accounted for at least one-third of all vulvovaginal infections. Bacterial vaginosis (BV) is an ecological imbalance of the vaginal microbiota affecting mostly women of reproductive age group. There is a decrease in vaginal acidity and in the concentration of lactobacilli accompanied by an increase of a 100-fold or more in the concentration of other micro-organisms. Lactic acid produced by the normal flora, which is Lactobacillus spp. causes hydrogen peroxide (H2O2) production, which is attributed to the acidic milieu of the vagina. This provides a local defense mechanism by inhibiting the growth of other organisms. Change in the normal vaginal flora causes change in pH simultaneously, which allows a variety of anaerobes and facultative bacteria to overgrow and cause chronic infection as well as abnormal vaginal discharge. BV is a clinical condition characterized by a thin, gray/off-white, homogenous, malodorous adherent vaginal discharge which is more noticeable after intercourse and menses, having pH > 4.5. Fishy odor is noticed on addition of 10% potassium hydroxide to the vaginal fluid (whiff test), and the presence of clue cells, a few or no lactobacilli, and small number (<1/hpf) of polymorphonuclear leucocytes (PMNs) are also the characteristic features of BV.

A trial was conducted on 120 female adults who were suffering from bacterial vaginosis and were treated with 120 million CFU/g of Bacillus coagulans SNZ 1969 tablet co-administered with T. Metronidazole 400 mg tablet thrice a day for 21 days. Significant reduction in symptoms and scoring was observed with the Bacillus coagulans SNZ 1969 +T. Metronidazole Vs plain T. Metronidazole.²

In another trial with 100 adult females suffering from vaginitis were given single tablet of Bacillus coagulans SNZ 1969 twice daily for 3 days and then once daily for the next 4 days. About 92% patients had complete relief from symptoms with the treatment.³

Another vaginal disorder which is common among young female population is Leucorrhea which might not be a major issue but it’s best to be resolved as soon as possible. In Leucorrhea, there is thick, whitish or yellowish vaginal discharge mainly due to estrogen imbalance but can increase during vaginal infection. Bacillus coagulans SNZ 1969 has been proven to be beneficial when administered in such cases and can lead to more than 80% symptomatic relief. An Indian trial was conducted with 25 females between the age of 18-40 years and it was found out that when these females were administered with 1 tablet of Sporlac(Bacillus coagulans SNZ 1969) in vagina for a week, 64% showed complete symptomatic relief, 20% showed moderate relief and 16% experienced no change in symptoms.⁴

In another multi-centre clinical assessment of125 females between the age group of 18-50 suffering from symptoms of Leucorrhea, were treated with Myconip (Bacillus coagulans SNZ 1969) 1 tablet twice a day for 7 days. The results of the trial showed complete relief in 101 patients i.e. 82% overall improvement.⁵

Role of probiotics as per International guidelines for the treatment of vulvovaginal infections⁶

Probiotics Aids Oral Health

You’ve probably heard of the gut microbiome but have you heard of the oral microbiome?

If you think about it, your oral cavity is actually part of your digestive system and, like your gut, has a rich microbial ecology. Also, like your gut, the balance of beneficial bacteria and harmful bacteria in your mouth impacts your health.

A substantial body of research shows that probiotics can help improve your digestive health. Does research support similar effects for probiotics and oral health?
Relatively smaller than in gut but significant number of trials have been conducted that supports the growing evidence for the role of probiotics in oral health. These trials prove the following benefits of probiotics in oral health:

Reduces dental plaque and gingival inflammation
Helpful for the treatment of apthous ulceration and chronic periodontitis

Probiotics to Prevent Cavities in Children
Tooth decay (dental caries) is a common condition found in children in which there damage to the tooth can happen when decay-causing bacteria in mouth make acids that attack the tooth’s surface, or enamel. This can lead to a small hole in a tooth, called cavity. If tooth decay is not treated, it can cause pain, infection and even tooth loss.

Oral health is a largely neglected area with dental caries widely prevalent across all age groups, more so in children with their fondness for confectionary.

In a study conducted with 150 children having dental caries showed that there is significant reduction of salivary mutans streptococci( bacteria causing tooth decay) count when they were given 150 million CFU/day of Bacillus coagulans SNZ 1969 for 14 days.¹

In another study conducted on 33 children between the age group of 12-15 yr old, there was a significant reduction in the gingival status and plaque inhibition after administration of sporlac ( Bacillus coagulans SNZ 1969) 30 ml powder with water, which was swished once daily for 3 min for a period of 3 weeks.^2/<sup?

Probiotics Reduces Dental Plaque and Gingival Inflammation
Dental plaque is a sticky bacterial mass that grows as a biofilm on the surface of your teeth. Dental plaque is one of the main causes of tooth decay and gum disease. Disrupting the buildup of dental plaque is important for preventing oral diseases like gingivitis and periodontitis (gum infection).

An Indian trial was conducted with 45 adult subjects suffering from chronic gingivitis (inflammation of gums). The trial results showed that treatment with Sporlac Plus (a product of Sanzyme Ltd. containing spores of Bacillus coagulans SNZ 1969), chlorhexidine mouthwash and normal saline water was effective in reducing plaque accumulation and gingival inflammation.³

Probiotics for Treatment of Moderate to Severe Gum Disease
In one of the direct studies on probiotics which was conducted with 50 adults suffering from apthous stomatitis and glossitis (oral ulcers) were given 120 million CFU per day of Sporlac (probiotic product containing spores Bacillus coagulans SNZ 1969) with vitamin B complex for 5 days thrice a day. The results showed that combination of Bacillus coagulans SNZ 1969 spores (Sporlac) with Vit B complex cured 43 of 50 patients(83%) followed by Sporlac alone and finally Vit B12 alone treatment.⁴

Conclusion
There appears to be a growing body of evidence that probiotic administration may impact several indicators of oral health: dental caries, gingivitis and periodontitis. With an increasing global problem of antibiotic resistance, probiotics contributing to preventing the effective treatment of microbial disease, by virtue of their natural therapy appear to be a novel approach for dental hygiene.

Bacillus coagulans SNZ 1969 is a spore forming probiotic strain, it is shelf stable and comes with a shelf life of 36 months. Thanks to the nature for providing it an outer coating which makes it resilient and versatile in terms of application. Such a nature of Bacillus coagulans SNZ1969 provides functional food, supplements, and personal care product formulators an immense opportunity to innovate and position products in the marketplace. Additionally, they endure GI track conditions better and less prone to ingredient interactions in a formulation as compared to traditional vegetative strains. It can be easily incorporated in toothpastes, mouth washes, lozenges, tablets, gums, candies etc. Hence, Bacillus coagulans SNZ1969 can help manage overall oral health effectively and safely through a wide variety of delivery forms.

References:
1. Jindal G et al., European Archives of Paediatric Dentistry 2011; 12: Issue 4
2. Contemp Clin Dent 2017; 8: 116-21.
3. Clinical trial of Sporlac in the treatment of recurrent Apthous Ulceration,U.P. State Dental Journal Vol.11, January 1980, 7-12
4. Jindal G et al., European Archives of Paediatric Dentistry 2011; 12: Issue 4

Are all probiotics the same?

Gut microbiome science has exponentially increased over the last two decades, as has the general population’s interest in harnessing this knowledge for better health. When it comes to science-backed tools for improving our gut microbiome, according to experts, diet diversity, prebiotics and probiotics are all worth considering.

For most of history, probiotics labored away in obscurity, however, with the rise of interest in health over the past decade, probiotics have become the rising superstars of nutritional product launches in the 21st century.

The global probiotics market is projected to grow to $69 billion at a CAGR (compound annual growth rate) of 7.0 percent through 2023. While probiotics continue as a top trend, misconceptions and confusion around the category and the benefits of these bacteria linger. And with the rise of even more products incorporating probiotics, it’s more important than ever for consumers to understand their benefits.

Probiotics can provide a wide number of health benefits, like aiding in digestion, strengthening the immune system, and maintaining an ideal ratio of good to bad bacteria.

The opportunity for product developers lies in integrating stable, efficacious probiotic strains into products which consumers enjoy every day. With the multitude of probiotic strains available, manufacturers should choose science-backed ingredients that are well-positioned and can be efficiently formulated.

So, are all probiotics the same? How to understand which probiotic strains will confer the maximum benefits? Which one will provide maximum opportunity for a well-formulated nutritional product?

There are several factors that can help you determine which strain to choose for your product.

1. Types of probiotics available: Vegetative / Spore forming bacteria
Lactobacillus is most common vegetative bacteria. Their cells are not particularly resistant to high heat or desiccation, and tend to be sensitive to the extremes of acid and alkaline conditions, as found in the stomach and small bowel. Studies have shown that most are quickly killed off in the harsh, acidic environment of the stomach and upper digestive tract. Because these bacteria are fragile, they require refrigeration to remain viable. Strains of lactobacillus are supplied in their living, vegetative states. That is, they are living organisms that require very specific environments to remain viable. Often found in fermented dairy products, like yogurt, these typically cannot be used in products that are shelf-stable, frozen, heated or subjected to extreme manufacturing processes.

Bacillus 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.

Spore-forming probiotics, particularly Bacillus coagulans SNZ 1969, can survive in most applications without the need for refrigeration by staying dormant until they reach the digestive tract. Bacillus coagulans SNZ 1969 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.

2. Get to Know the Strain
Many probiotics contain mixtures of two or more individual strains of bacteria or yeasts. Scientists have found supplementation with different probiotic strains to be linked to different types of benefits, such as digestive and immune health. But you can’t take the positive findings of one study that looks at a particular strain and its impact on health and use it to substantiate the health benefits of another strain. Probiotic strains each possess their own distinct characteristics. These properties may influence safety, efficacy, benefits and the strain’s suitability for certain applications.

3. Formulation viability
When considering products with the health benefits of probiotics, finding a strain that not only provides clinically supported efficacy but is easy to formulate can be difficult. Often, developers have to deal with the technical challenges that are inherent to the more common probiotic strains such as stability, effects of pH, amount of the remaining beneficial bacteria (CFU/g), shelf life etc. Manufacturers that want to promote the benefits of probiotics in their foods or beverages must fortify those products with high-quality, survivable, science-backed probiotic strains.

Does Bacillus coagulans SNZ 1969 meet the current demands of manufacturers?

SNZ1969 is one of the oldest and most widely used strains of B. coagulans worldwide. It is a rod-shaped, slightly acidophilic, gram-positive, catalase-positive, spore forming, thermotolerant, aerobic to microaerophilic, highly resilient probiotic bacteria.

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 SNZ1969 has been marketed in India under the brand name “SPORLAC” and has been used as a therapeutic probiotic for over 45 years.

SNZ1969™ 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.

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. SNZ1969 is of Non-GMO origin and is produced in a GMP, FAMIQS and NSF certified facility.

SNZ1969 is gifted with a natural encapsulation which makes it possible to withstand harsh conditions making it an ideal probiotic option for shelf stable processed foods. Whereas the conventional vegetative probiotic organisms such as lactobacillus and bifidobacterium often require refrigeration hence restricting their use mostly to refrigerated foods such as yoghurts.

SNZ 1969 is supported by twenty plus scientific publications covering gut health, Immunity against GI track pathogens, inhibition of food borne pathogens, inhibition of bacteria causing dental carries & gingivitis and bacterial vaginosis.

In conclusion, Sanzyme Biologics’ Bacillus Coagulans SNZ 1969 can be an ideal choice for nutritional ingredient and diet supplement manufacturers in this rapidly evolving health market.

References:
1. MarketsandMarkets, Global Probiotic Market Forecast to 2023, Dec 2018.
2. GlobalData – Ingredient Insights: Digestive Health, August 2018.
3. Kerry Global Consumer Survey – Digestive & Immune Health, 2019.
4. NIE Functional Food, Jan 2020

Are probiotics safe for your infants?

The human gastrointestinal (GI) tract represents one of the largest interfaces (250–400 m2) between the host, environmental factors and antigens in the human body. The collection of bacteria, archaea and eukarya colonising the GI tract is termed the ‘gut microbiota’ and has co-evolved with the host over thousands of years to form an intricate and mutually beneficial relationship.

The development of the microbiota is generally believed to begin from birth, although this dogma is challenged by a limited number of studies in which microbes were detected in womb tissues, such as the placenta. After birth, the GI tract is rapidly colonised, with life events such as illness, antibiotic treatment and changes in diet causing chaotic shifts in the microbiota.

In early stages of development, the microbiota is generally low in diversity and is dominated by two main phyla, Actinobacteria and Proteobacteria. During the first year of life, the microbial diversity increases, and the microbiota composition converges towards a distinct adult-like microbial profile with temporal patterns that are unique to each infant. By around 2.5 years of age, the composition, diversity and functional capabilities of the infant microbiota resemble those of adult microbiota. In more recent years, we’ve come to understand the importance of gut microbes and their role in regulating the immune system. The early microbiome is what trains your immune system. This is extremely important because it is what helps prevent disease and fight infection. Babies have a very clean system, so helping build up their gut health will allow their microbiome to more effectively manage irritants, toxins and other threats. Good gut health not only controls illness but also influences the development of other organs, such as the brain, skin, liver, and kidneys. All of this is vital to the lifetime of better health.

Probiotics are the beneficial bacteria that balance the pathogenic bacteria in our bodies. They are found in different foods, supplements etc. A daily dose of probiotics helps improve gut health and each strain serve a specific role for creating balanced system. Some of the ways in which probiotics help infants are:

Boosted Immunity – Over 80% of our immune system is in our gut, making this the center of our health & wellness. Balancing your babies gut flora will improve their ability to handle illness, deal with inflammation and improve digestion.
Ease colic or Reflux – The imbalance of microbiota has adverse effects on babies. Colic, reflux, irregularity of the bowls or constipation can all come from poor gut health.
Reducing risk of obesity and Asthma – Low levels of healthy bacteria in the GI tract can put people at a greater risk for obesity and asthma. Using a daily probiotic supplement can help reduce the risk of these issues later in life.

Factors Shaping the GI Microbiota
Feeding methods can also affect the abundance of some bacterial groups in the gut microbiota of infants. For example,fucosylated oligosaccharides present in human milk can be utilised by Bifidobacterium longum and several species of Bacteroides allowing them to outcompete other bacteria such as E. coli and Clostridium perfringens. Whilst the abundance of Bifidobacterium spp. in breast-fed infant microbiota is typically high this is reduced in formula-fed infants. Furthermore, formula-fed infant microbiota has an increased diversity and altered levels of other groups such as E. coli, Clostridium difficile, Bacteroides fragilis and lactobacilli. Several environmental factors have been implicated in shaping the microbiota , such as antibiotics but not host-targeted drugs, shape the physiology and gene expression of the active human gut microbiome . Antibiotic treatment dramatically disrupts both short- and long-term microbial balance, including decreases in the richness and diversity of the community. The exact effects and the time for recovery of the microbiota following antibiotic administration appear to be individual-dependent.

Treatment of acute Diarrhea and necrotizing Colic in Infants
Acute diarrhea is a burdensome disease with potentially harmful consequences, especially in childhood. Diarrhea refers to the abrupt onset of three or more loose or liquid stools per day. More specifically, acute diarrhea is defined as an abnormally frequent discharge of semi-solid or fluid fecal matter from the bowel, lasting less than 14 days. Although it is a preventable disease, acute Diarrhea remains a major cause of morbidity and mortality in children worldwide, resulting in 525,000 deaths per year among those younger than five years. Most of these mortalities occur in developing countries. Currently, the World Health Organization (WHO) recommends treatment of acute childhood diarrhea with oral rehydration salts (ORS) and continued feeding for the prevention and treatment of dehydration, as well as zinc supplementation to shorten the duration and severity of the diarrheal episode. Probiotics are living micro-organisms that, upon ingestion in certain numbers, exert health benefits beyond inherent general nutrition. It has been suggested that probiotics modulate the immune response, produce antimicrobial agents, and compete in nutrient uptake and adhesion sites with pathogens. The European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) and the European Society of Pediatric Infectious Diseases (ESPID) currently recommend the use of Saccharomyces boulardii in the management of children with acute Diarrhea as an adjunct to rehydration therapy. Also, a systematic review and meta-analysis of randomized controlled trials conducted by Sanofi Aventis GMbh found Bacillus clausii to be an effective therapeutic option in acute child diarrhea. (Nutrients 2018, 10, 1074).

Future Perspectives
In conclusion, newborn and children possess less diverse and an unstable gut microbial composition which is more susceptible to variations caused by external factors. Due to these considerations, the use of probiotics for preventive or therapeutic agents is an established fact for some enteric diseases such as acute diarrhea and NEC, but it can be feasible for several diseases which are not apparently linked to the GIT microbiota composition, such as obesity and neurologic diseases. Unfortunately, most of the experimental evidences for these diseases regard in vitro studies, cell line experiments and, in some cases, animal experimental model researches. When these preliminary results are consolidated, clinical intervention trials using various strains possessing the GRAS and the QPS status can be planned to achieve definitive results on humans.

About Sanzyme Biologics:

Sanzyme Biologics is a 50 year old biotechnology company based in Hyderabad, India. Sanzyme specialises in the production of probiotic bacteria. Sanzyme Biologics has obtained Generally Recognized as Safe (GRAS) approval relating to use of Bacillus coagulans SNZ 1969™ in infant formula. The US Food & Drug Administration (FDA) issued the company with a GRAS Notice known as a ‘no objection letter’. It states that it has no questions regarding the safety of Bacillus coagulans SNZ 1969™ spore preparation marketed by Sanzyme Biologics when used in infant formula.

How Probiotics support your immune system?

During the unprecedented Coronavirus pandemic, we’ve seen a renewed focus on ways to “support your immune system.” The obvious question is: can probiotics, by helping your gut be as healthy as possible, also support your immune system? Although probiotics are proven to help digestion and optimal gut health, recent studies indicate probiotics also protect and enhance your immune system.

The primary reason probiotics, by strengthening your gut health, help your immune system function better is simple. Your gut and immune system have a symbiotic relationship. For example, 70-80% of your immune cells are located in your gut.The health of your gut directly impacts the overall health of your entire immune system.

Healthy guts make healthy immune systems. Conversely, compromised, unhealthy guts erode the effectiveness of immune system function. That leads to potentially more illnesses like common colds, flu, and many other infections – potentially even COVID-19.

Scientists have known for years that our microbiome helps keep overactive immune responses (leading to conditions like IBS(Irritable Bowel Syndrome) and other autoimmune diseases in check. However, they were still unsure of the exact mechanisms that drive this interaction.

Preventive Strategies against Viral Infections

Recently, the risk of viral infection has dramatically increased owing to changes in human ecology such as global warming and an increased geographical movement of people and goods. However, the efficacy of vaccines and remedies for infectious diseases is limited by the high mutation rates of viruses, especially, RNA viruses. Various strategies, such as those using vaccines and antibiotics, have been exploited for the prevention and treatment of infectious diseases, but infection control has not yet been achieved at a sufficient level.

It is generally acknowledged that the main prophylactic measures against these infectious diseases are vaccinations and everyday hygienic behaviors such as gargling and hand-washing. Nagatake et al. outlined that gargling with a povidone-iodine solution was effective to reduce the incidence of episodes of acute respiratory infections, since colonized bacteria were destroyed by gargling. Heijne et al. reported that enhanced hygienic measures including proper hand cleaning using soap and disposable paper towels effectively limited the transmission. Although vaccines are promising prophylactics against influenza infection, their efficacy is limited by the frequent and fast mutation of RNA viruses. In the present situation, without an effective vaccine or medicine, the prevention of viral transmission must rely mainly on basic measures including quarantine and thorough hand washing after physical contact.

With the progress of research on the relationship between the microbiota and diseases in recent years, commensal intestinal bacteria have been investigated for their ability to modulate the host immune system, not only in healthy individuals but also in those who are suffering from a wide range of diseases. It has been revealed that commensal bacteria also regulate regulatory T cells, type 3 innate lymphoid cells, and T helper 17 cells through the recognition of the bacteria themselves or their metabolites/products by the immune cells and greatly affect mucosal immunity.

Probiotics act on both the innate and acquired immune systems and have the potency to decrease the severity of infections in the gastrointestinal and upper respiratory tracts. Probiotics are defined as live microorganisms that have health benefits for the host, and they are generally consumed as a component of fermented foods such as yoghurt, cheese, and pickles or as supplements.

For example, oral administration of Saccharomyces boulardii and rehydration significantly shortened duration of diarrhea in acute rotavirus gastroenteritis children in Bolivia, compared with control rehydration alone. Detailed mechanism was not available.

Enhancing host intestinal immune responses may be an important mechanism for Saccharomyces boulardii -mediated protection against diarrheal illnesses.

Also, most pathogens enter the body through mucosal surfaces. Mucosal immunization, a non-invasive needle-free route, often stimulates a mucosal immune response that is both effective against mucosal and systemic pathogens. The development of mucosally administered heat-stable vaccines with long shelf life would therefore significantly enhance immunization programs in developing countries by avoiding the need for a cold chain or systemic injections. Currently, recombinant vaccine carriers are being used for antigen delivery. Engineering Bacillus subtilis for use as a non-invasive and heat stable antigen delivery system has proven successful. Bacterial spores protected by multiple layers of protein are known to be robust and resistant to desiccation. The use of Bacillus subtilis to express antigens that can be administered either intranasally or sublingually is providing new insights in the area of mucosal vaccines
(Hum Vaccin Immunother. 2012 Jul 1; 8(7): 979–986.)

In February, 2020, China’s National Health Commission and National Administration of Traditional Chinese Medicine suggested the use of probiotics in patients with severe COVID-19.
(Lancet Gastroenterol Hepatol.2020 Published Online April 24, 2020)

Conclusion
Probiotic treatment is a promising research arena in the medical sciences, since probiotics alone, or together with prebiotics, have potential in the modulation of gut microbiota and immune responses in the host. However, a number of scientific reports are identical in terms of the role of probiotics in preventing obesity, inflammatory diseases, and cancer. Probiotics have a positive influence on the innate immunity, exerting several antiviral properties. Although there are insufficient research publications regarding how probiotics induce immunomodulatory effects. Preliminary data obtained by various research laboratories have been encouraging, but numerous randomized clinical studies will be required to clearly establish the potential of probiotics in preventing and treating various diseases. Such studies will allow identification of the probiotics that are best suited to various diseases.