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)

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.

Introduction to Sanzyme’s Bacillus Subtilis SNZ 1972

Bacillus subtilis is a rod shaped, probiotic bacterium. It is found in the soil like most members of the Bacillus family and the gastrointestinal tract of ruminants and humans. Bacillus subtilis bacteria secrete commercially important industrial enzymes such as amylase, protease,pullulanase, chitinase, xylanase, lipase, among others. Bacillus subtilis is also responsible for producing antibiotics like bacitracin (effective against Gram-positive bacteria), polymyxin (affective against Gram-negative bacteria), difficidin (a broader spectrum), subtilin, and mycobacillin.

Bacillus subtilis SNZ 1972 was originally isolated from the soil by Sanzyme Biologics after extensive screening and characterization of various strains of Bacillus subtilis. By virtue of ability to form stress-resistant shield (endospore) Bacillus subtilis SNZ 1972 can protect itself against many stress situations such as acidic, alkaline, osmotic, or oxidative conditions, and heat. It survives through all manufacturing processes and it does not show decrement in viability of cell.

Safety of Bacillus subtilis SNZ 1972 is verified by a series of in vitro and in vivo studies. Based on these scientific procedures, Bacillus subtilis SNZ 1972 spores received self-affirmed GRAS (generally recognized as safe) status and it is intended for use as a food ingredient for consumers in the following food categories: bakery, cereal bars, dairy products and vegetable and fruit juices. Bacillus subtilis SNZ 1972 has also been studied for healthy digestion


Disclaimer: These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.

Introduction to Sanzyme’s Bacillus Coagulans SNZ 1969


Bacillus coagulans is a spore forming, probiotic strain. In 1949, Dr.Oki Nakayama from the University of Yamanashi in Japan isolated a species of spore forming lactic acid bacteria from green malt. It was deposited in the ATCC by Japanese researchers and later reclassified as Bacillus coagulans. In 1972, at the request of Sankyo Corporation, the Japanese Ministry of Health and Welfare approved the use of a B. coagulans strain (designated as strain SANK 70258).Subsequently, in 1973, Sankyo Corporation (currently known as Daiichi Sankyo Co. Ltd) offered formulation and fermentation technology to Sanzyme Limited (earlier known as Uni-Sankyo Ltd).

The Brand and Legacy

Bacillus coagulans is marketed in India under the brand name Sporlac and has been designated as strain ‘Bacillus coagulans SNZ 1969’ by Sanzyme Limited and Sanzyme Biologics.The strain Bacillus coagulans SNZ 1969 is deposited with Microbial TypeCulture Collection and Gene Bank, India (MTCC 5724P) and Belgian Coordinated Collections of Microorganism (BCCM™ILGM; LMG S−27484). US FDA has determined Bacillus coagulans SNZ 1969 strain as Generally Recognized As Safe (GRAS) based on scientific procedures (US FDA Notification GRN-597).

A Stronger Probiotic: Shielded, Resilient and Survives as the fittest!!

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. It sustains extreme manufacturing processes like fermentation, freezing, thawing,drying, and rehydration, making it the ideal probiotic for food applications. The safety and reliability of Bacillus coagulans SNZ 1969 is established not only by scientific studies but also by its unprecedented history of use for 46 years. Bacillus coagulans SNZ 1969 has also been studied for benefits in gut health, oral health and vaginal health.



Disclaimer: These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.

Introduction to Sanzyme’s Bacillus clausii SNZ 1971

Role of Bacillus clausii in gut dysbiosis

Normal microbial flora in the gut (called as gut microbiome) is considered as part of a defence system of gut. Our gut is exposed to unhealthy foods, allergens, antibiotics, and microbial and other toxins which causes adverse deviation of microbiome composition (known as gut dysbiosis). Probiotics bacteria may modulate and cross-talk with gut barrier and helps in replenishing gut microbiome. Bacillus clausii represents one of the most studied probiotics in this context. It also possess properties like resistance to commonly used antibiotics and production of antimicrobial substances against some pathogenic bacteria.

Why Bacillus clausii SNZ 1971

Sanzyme’s Bacillus clausii SNZ 1971 is a spore-forming bacterium that lives in the soil.Bacillus clausii SNZ 1971 is able to survive passage through the hostile environment like gastric and bile acid and germinate in the gut. Hence, though it is not the part of normal resident intestinal flora, it has the ability to colonize the intestine even in presence of antibiotics. By this way it helps in replenishing microbial flora and corrects dysbiosis.

Bacillus clausii SNZ 1971 received self-affirmed GRAS (generally recognized as safe) status and it is intended for use as a food ingredient for consumers in the following food categories: bakery (biscuits, pastries, cookies, brownies, crackers), cereal bars, dairy products (yogurt,cottage cheese, hard cheeses, and milk drinks and substitute products) and vegetable and fruit juices. Bacillus clausii SNZ 1971 has also been studied for its safety and its benefit in gut health.



Disclaimer: These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.