Probiotics | Sanzyme Biologics

The community of microorganisms that thrives on us and present in us is called the “microbiome”. We have trillions of microbes in our body with diverse composition of the microbes and each individual has a unique microbial footprint. These microbes are a combination of: Bacteria, Fungi (including yeasts), Viruses. Protozoa. Bacteria are usually taken as negative micro-organisms, as something that makes us sick. Usually they are considered as germs that cause diseases. But our body is full of bacteria, both good and bad. Probiotics are often called “good” or “helpful” bacteria because they help keep our gut healthy. For a microbe to be called a probiotic, it must have several characteristics. These include being able to: Resistance to gastric acidity, Bile acid resistance, Adherence to mucus and/or human epithelial cells and cell lines, Antimicrobial activity against potentially pathogenic bacteria or fungi, Ability to reduce pathogen adhesion to surfaces.

Thus “Probiotics” are live microorganisms which are promoted with claims that they provide health benefits when consumed, generally by improving or restoring the gut flora. World Health Organization (WHO) defines probiotics as “live microorganisms which when administered in adequate amounts confer a health benefit on the host.” But a growing probiotics market has led to the need for stricter requirements for scientific substantiation of putative benefits conferred by microorganisms claimed to be probiotic.

What Are Probiotics?

We are surrounded by an important biological system of microorganisms. This biological system is the human microbiome. It has been known for some time that the human body is inhabited by at least 10 times more bacteria than the number of human cells in the body, and that the majority of those bacteria are found in the human gastrointestinal tract. The composition of the gut microbiota varies during childhood until the individual reaches adulthood. The relationship between the host and the gut microbiota is symbiotic. The mainly commensal intestinal microbiota contribute to the enhancing resistance against infections, differentiation of the host immune system, synthesis of certain nutrients such as vitamins, short-chain fatty acids and other low molecular mass molecules.

Thus we can say that “Probiotics” are a combination of live beneficial bacteria and/or yeasts that naturally live in our body. These beneficial bacteria helps us in many ways, including fighting off bad bacteria especially in the digestive system.

Probiotics live throughout our entire body (not just our gut).Though the most common place linked to beneficial microbes is our gut (mostly large intestines), there are several locations in and on our body that host good microbes. These locations are in contact with the “outside world” and include:

  • Gut.
  • Mouth.
  • Vagina.
  • Urinary tract.
  • Skin.
  • Lungs.

How Do Probiotics Work?

The main role of probiotics, or good bacteria, is to maintain a healthy balance in our body. This balancing act is naturally happening in our body all of the time. Good bacteria is just a natural part of our body. Eating a well-balanced diet rich in fiber every day helps to keep the number of good bacteria at proper levels.

When there is an infection, we lose “good” bacteria and there’s more bad bacteria causing our system to go out of balance. Probiotic helps eliminate extra bad bacteria and thus returning the balance. Thus probiotics replace good bacteria and keeps us healthy by supporting immune function and controlling inflammation.

Probiotics brings this balance by communicating with the host by pattern recognition receptors, which modulate key signaling pathways, to enhance or suppress activation and influence downstream pathways. This recognition is crucial for eliciting measured antimicrobial responses with minimal inflammatory tissue damage.

Probiotics can also help by:

  • Help our body digest food.
  • Keep bad bacteria from getting out of control and making sick.
  • Create vitamins.
  • Help support the cells that line our gut to prevent bad bacteria that we may have consumed (through food or drinks) from entering the blood.
  • Breakdown and absorb medications.

What Are the Different Types of Probiotics?

Probiotics are made of both bacteria and yeast. Though there are many types of bacteria that can be considered probiotics, there are two specific types of bacteria. These include:

Spore Formers Vegetative strains Yeast
Bacillus coagulans Bifidobacterium breve Saccharomyces boulardii
Bacillus clausii Bifidobacterium longum
Bacillus subtilis Lactobacillus acidophilus
Bacillus indicus Lactobacillus casei
Lactobacillus rhamnosus

Sources of Probiotic Strains

Probiotics can be an isolate of human origins like human large intestine, small intestine, or even breast milk. It can also be from animal origins, various foods such as raw milk or fermented food products. Probiotic strains isolated from human microflora are well characterized by high adhesive levels to the human intestinal epithelial barrier than others and more likely to be safe.

How Effective Are Probiotics?

Probiotics help us in many ways, including fighting off bad bacteria when we have too much of it and in turn helping us feeling better.

Probiotics have shown promise for a variety of health purposes:

  • Gut dysbiosis-
    • Diarrhea (both diarrhea caused by antibiotics and from Clostridioides difficile (C. diff) infection).
    • Constipation.
    • Inflammatory bowel disease (IBD).
    • Irritable bowel syndrome (IBS).
    • Yeast infections.
    • Travelers diarrhea
  • Prevention of necrotizing enterocolitis and sepsis in premature infants,
  • Treatment of infant colic,
  • Upper respiratory infections (ear infections, common cold, sinusitis).
  • Treatment of dental caries (Tooth decay) and periodontal disease (Gum disease)
  • Prevention of Allergies- Rhinitis, Asthma, Atopic dermatitis
  • Urinary tract infections

Benefits of Probiotics?

The bacterial strains used in the supplements and probiotic foods help to play a central role in: colonization in the intestinal, respiratory and urogenital tracts, inhibition of the carcinogenesis, directly or/and indirectly, via the stimulation of the immune system, the metabolism of lactose, the absorption of calcium and the potential of vitamin synthesis, the reductive potential of yeast and vaginal infection, alleviating the rate of constipation and diarrheal disorders, mitigating gastritis and ulcers, helping to reduce acne, rash face and skin problems, and the production of natural antimicrobials.

Essential Properties for effective and successful probiotic:

It is of utmost importance that the probiotic strain survives the site where it is presumed to be active. For maximum activity, the strain should be able to proliferate and colonize at this specific location.

Besides, it should also be tolerated by the immune system. It should not be pathogenic, allergic, or mutagenic/carcinogenic.

Probiotics for human should have ‘generally regarded as safe’ status, with a proven low risk of inducing or being associated with the etiology of disease. The probiotic organisms should preferably be of human origin, must be able to survive and grow in the in vivo conditions of the desired site of administration, and thus must be able to tolerate low pH and high concentration of bile acids. For successful application in foods, the probiotic used should also be technologically compatible with the food-manufacturing process. In addition to that, the foods containing the probiotic bacteria must maintain the characteristic sensory attributes of the traditional food.

Efficacy studies-Double-blind, randomized, placebo-controlled phase 2 (efficacy) studies should be undertaken with probiotic foods/pills (where the placebo is the carrier devoid of the test probiotic). The principal outcomes of efficacy studies on probiotics should be proven benefits in human trials, such as statistically and biologically significant improvements in conditions, symptoms, signs, well-being, or quality of life; reduced risk of disease or longer time to next occurrence; or faster recovery from illness. It is recommended that the human trials be repeated by more than 1 center for confirmation of results, and results published in peer-reviewed scientific or medical journals. Where food is considered, no adverse effects related to probiotic administration should be experienced.

What Are Probiotic Supplements

The number of beneficial microbes can increase in our body by the foods we eat. Thus the amount of good microbes can be increased in our body through foods, drinks and supplements. Certain foods have probiotics (good bacteria) in them and can benefit the health of our microbiome. Fermented foods in particular (yogurt and pickles, for example) are home to a host of good bacteria that benefit our body. There are also fermented drinks like kombucha (fermented tea) or kefir (fermented dairy drink) that introduce extra probiotics into our diet. Apart from food, probiotics can be added to our diet through dietary supplements/ functional foods. Probiotic functional foods can be defined as products containing specific probiotic microbes with scientifically proven clinical efficacy for the final product intended for human use. Probiotic-supplements are a way to add good bacteria to our body.

Orally administered probiotics encounter various challenges on their journey through the mouth, stomach, intestine and colon. The prerequisites for probiotic action include survival in and adhesion to specific areas of the gastrointestinal tract and competitive exclusion of pathogens or harmful antigens. After oral administration, the probiotic strains are exposed to low pH of the stomach and bile salts in the enteral section of the alimentary tract of the host. Many of them often fail to survive conditions of the passage. Oral administration of at least 107 cells of a probiotic strain per milliliter or gram of food should ensure a positive effect to the host even when some of them do not survive the unfavorable conditions of the gastrointestinal passage. Thus to sustain metabolic and biochemical activity of probiotics during gastrointestinal passage probiotic cells can be encapsulated for survival.

How to choose a probiotic supplement?

There are several ways we can take a probiotic supplement. They come in a variety of forms, including in:

  • Foods.
  • Drinks.
  • Capsules or pills / Sticks /Tablets
  • Powders/Sachets
  • Liquids/Vials

Probiotics Uses

Probiotics may have a variety of effects in the body, and different probiotics may act in different ways. Probiotics might:

  • Help our body maintain a healthy community of microorganisms or help our body’s community of microorganisms return to a healthy condition after being disturbed.
  • Produce substances that have desirable effects
  • Influence on our body’s immune response.

Safety- Probiotic Species and Strains Must Be Safe for Human Consumption

For daily use of probiotics by the general healthy population, potential safety concerns arising from the administration of live micro-organisms must be addressed. Many species of lactic acid bacteria, bifidobacteria and yeasts, representing most of the commercially available probiotic strains, are judged to be safe for use in foods and supplements. This is because they belong to genera and species with a documented history of safe use, either as probiotics or as starter cultures. Going beyond history of safe use, the European Food Safety Authority (EFSA) has maintained lists of species presumed to be safe for human consumption in foods under the “Qualified Presumption of Safety” (QPS) concept since 2007. The QPS approach is an evidence-based, thorough and regularly updated approach to communicate on the safety of specific species of micro-organisms. It should be noted that the scope of QPS is food consumption by the general, healthy population and does not specifically take into consideration potential risks for vulnerable populations or non-food uses of probiotics, if a strain does not belong to a QPS species, the Novel Food regulation may apply before it can be brought to market. Other jurisdictions have other procedures to assess safety of probiotics, such as the generally recognized as safe (GRAS) regulation in the United States.

Species- and Strain-Specific Safety Criteria for Probiotics

Any safety evaluation is predicated on proper species identification. In addition, identification of genus or species-specific risk factors, and testing at strain level is required. Most important among these is the absence of acquired antimicrobial resistance genes or known virulence factors. Within the EU, EFSA has issued several guidelines describing phenotypic cut-off susceptibility and resistance values for relevant antibiotics and methods for determining these. The guidelines should also be used for the assessment of bacterial and antimycotic susceptibility for yeasts. Standardized analytical methods are available for the phenotypic screening of candidate bacterial strains. If resistance above cut-off values is observed, further characterization is required. WGS of the strain will confirm the presence or absence of known genes involved in the observed resistance. In cases where putative resistance genes are detected, it is recommended to determine if transposable elements are in their genomic vicinity. If this is the case it cannot be excluded that the resistance gene is transferable, and commercialization of the strain is not recommended.

Why Probiotic strains matter:

It was recognized that it is necessary to know the genus and species of the probiotic strain, and strain identity is important to link a strain to a specific health effect as well as to enable accurate surveillance and epidemiological studies. Probiotic strains should be deposited in an internationally recognized culture collection. In vitro tests are critical to assess the safety of probiotic microbes and are also useful for functional characterization and to gain knowledge of the mechanism of the probiotic effect initially through animal studies.

strain specificity

In recognition of the importance of assuring safety, even among a group of bacteria that is generally recognized as safe, it was recommended that probiotic strains be characterized at a minimum with the following tests: 1) determination of antibiotic resistance patterns, 2) assessment of certain metabolic activities (d-lactate production, bile salt deconjugation), 3) assessment of side effects in humans, 4) epidemiological surveillance of adverse incidents in consumers, 5) testing for toxin production (if the strain under investigation belongs to a species that is a known mammalian toxin producer), and 6) testing for hemolytic activity if the strain under evaluation belongs to a species with known hemolytic potential.

Probiotic supplement labelling:

It was recommended that on probiotic supplement, following information should be described on the label: genus, species, and strain designation; minimum viable numbers of each probiotic strain at end of shelf-life; the suggested serving size, which must deliver the effective dose of probiotics related to the health claim; health claim; and proper storage conditions.

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 30 countries to meet ingredient requirements in biotech space in the pharmaceutical, food, supplement and animal health segment