Not all Probiotics Are Created Equal – How Industry is Fooling the Consumer

The well anticipated, follow up to STATIC I; STATIC BLOG II is here too unveil the hidden truth of Probiotic products and why some probiotics should not be called probiotics.

To Spore, Or Not To Spore; that is the question. Not many consumers will be aware of this, but probiotics on the market consist of two very different types: 1) Cultured strains containing live organisms, such as L. acidophilus, and 2) probiotic “spores”, such as Bacillus coagulans. Live probiotic strains have shown many positive health benefits, and it seems the number of clinical studies showing beneficial effects are growing faster than the probiotics themselves! Yes, it is a fact that live, refrigerated, probiotic strains sold as supplements do not grow quickly, unlike the more room-temperature-stable spore forming bacteria. Spores grow very rapidly once they reach the GI tract. But is growth rate equal to benefit? Do spore probiotics actually confer intestinal health in the way that live organisms do, or are spores just hope in a bottle?

Table 1
Reference-1: Probiotics and Antimicrobial Proteins ISSN 1867-1306 Probiotics & Antimicro. Prot. DOI 10.1007/s12602-013-9126-2

What actually separates spore from live organisms? Let’s take a look. One of the most popular spores to form a probiotic is Bacillus coagulans. There are innumerable forms of the spore former, and they all have letters and numbers that make it sound like a pharmaceutical drug or the location code for a particular docking station in the Star Trek Enterprise, e.g.: there is the IS2 Spore, GBI-30 Spore former, the M-16V (like the machine gun, go figure) and DR10, AR-1 and DPPIV-I. I wonder who the first company was that started the Star Trek Docking Location number system… To get back to the point, just what is the difference between spore forming hopefulness and live, non-spore forming probiotic organisms?

Well, a HUGE degree of separation exists for effectiveness. Live organisms, which do not proliferate spore formation, have an overwhelmingly more positive effect in clinical studies (emphasis on effect) than spore formers. For example, CHR Hansen claims their live Lactobacillus rhamnosus probiotic strain is the “world’s best documented probiotic strain.” According to CHR Hansen, L. rhamnosus; “…has been used in food and dietary supplements since 1990, has been described in more than 760 scientific publications and studied in more than 260 clinical studies.”

Ok, so live strains show better proof of effectiveness. The problem is, not all applications can utilize the live organism and people are not happy with being limited to refrigerated capsules, yogurt or strange looking mucus-like liquid (some of you know what I am talking about here). The consumer doesn’t want to swallow a refrigerated capsule, no, this is not good enough. OK, sorry, but I have to rant: Today’s consumer wants their probiotics to be candy treats, or taste like Philly Cheese Steak Sandwiches. I actually like that idea; Philly Cheese Steak Probiotics. Why not? If Domino’s can make it into a pizza, why can’t Virun turn it into a probiotic? I apologize for the digression; it’s almost dinner time.

To appease the consumers’ desire for convenient, treat-oriented alternatives, we now have probiotic chewables, gummies and stick packs. But live-organisms cannot survive the manufacturing process of a gummy or live through ambient-temperature storage conditions, so live strains are not used in these types of applications. In applications where heat and room temperature are as much a part of the product as the hard to pronounce spore former itself, the spore is used instead. But (back to the real question), which is better? …the spore or the live organism?

Not only does research lean heavily upon the live organism (non-spore forming) in showing better effectiveness in clinical studies overall, but the finished product-brands will themselves admit that they would prefer a live organism in their shelf stable application, gummy, stick pack or room temperature capsule, rather than the spore forming alternative. If you dig a little deeper you’ll find that spore forming probiotics are not well understood, and little proof exists to indicate the clinical effectiveness in humans is comparable to the live organism, non-spore forming strains typically used in refrigerated probiotic applications. In fact, although B. coagulans is commonly used to treat such afflictions as diarrhea caused by gastroenteritis, travelers’ diarrhea, diarrhea cause by antibiotics, Irritable Bowel Syndrome, Crohn’s Disease, and constipation, according to MedlinePlus, the National Institutes of Health’s Web sites and the world’s largest medical library; the Natural Medicines Comprehensive Database rates effectiveness based on scientific evidence according to a scale of Effective, Likely Effective, Possibly Effective, Possibly Ineffective, Likely Ineffective, Ineffective, and Insufficient Evidence to Rate; and guess where B.coagulans falls on the scale:

The effectiveness ratings for BACILLUS COAGULANS are as follows:
Insufficient evidence to rate effectiveness for…

• Diarrhea. Including viral diarrhea in children, traveler’s diarrhea, and diarrhea caused by antibiotics.
• Growth of bacteria in the intestine. Early evidence shows that using a specific probiotic product containing Bacillus coagulans and fructo-oligosaccharides twice daily for 15 days per month for 6 months might modestly decrease stomach pain and gas in people with of potentially harmful bacteria in the intestine.
• Helicobacter pylori infection. Which causes stomach ulcers.
• Inflammatory bowel disease (IBD, Crohn’s disease, ulcerative colitis).
• As an agent added to vaccines to improve their effectiveness.
• Cancer prevention.
• Clostridium difficile colitis.
• Digestion problems.
• Immune system strengthening.
• Irritable bowel syndrome (IBS).
• Respiratory infections.
More evidence is needed to rate Bacillus coagulans for these uses. There has been no reliable research done in people.

Wow. No reliable research done in people…should it even be called a probiotic?

One thing is for sure, probiotics are a new and amazing category for foods and supplements alike. On the growth rate of probiotics, Research and Markets states that “The global human microbiome market is estimated to reach USD 899.1 million by 2025, growing at a CAGR of 21.1% during the forecast period (2022-2025).” The probiotics category is likely one of the fastest growing supplement ingredient categories, besides Omega EPA DHA. Not only is this market exploding, but the acknowledged health benefits seem to be growing as well. From intestinal health to brain health, probiotics, dubbed as “Psychobiotics,” are being linked to intestinal health dictating neurological behavior. Recent studies are suggesting that poor intestinal health is linked to depression and anxiety. And who knows, maybe there will be new probiotic strains that help grow new hair, or replace caffeine as an energy supplement. I already have some good names picked-out, like Probiotic HA50-Iws and EN49-Iws (HA is for hair and EN energy). How’s that for creative branding?

probiotics bay

Three Separations of Product Brands and Distribution from a Developer

A formulator’s perspective taking a microscopic look at the world of supplements and functional foods from a technical standpoint, not as a consumer…
Photo of Philip BromleyBy Philip Bromley, CEO and Co-founder of Virun® NutraBiosciences®

Even though I am CEO and co-founder of Virun® first and foremost, I am a formulator, product developer, and inventor at heart who’s developed 100s of products and worked with numerous companies throughout my career.  Virun specializes in creating novel delivery technologies and formulations for fragile or difficult to use ingredients for suppliers, distributors, and manufacturers to incorporate into many food, beverage and supplement products.  People come to Virun and ask us to make crazy products that should be impossible to develop.  I have been known to literally get off the phone with a client, stand up from my computer, and look around at everyone next to me, here in the lab in utter disbelief.  Then I say, “How the hell are we going to make a 500mg Ugandan tree bark terpene phenols combined with MCT from coconut oil along with Phyto CBD delivered in a liquid emulsion, great tasting, coffee creamer?”.  But you know what, we laugh, brainstorm, figure out the process and produce the damn batch to get it done in record time.   You see, at the end of the day, our clients have analyzed the market and know there is an opportunity for this product. That’s why they come to us because we create technology to do the impossible. Plus, we are good at taking feedback and we simply “get’r done” on time too.

This leads me to my first separation of product brands and distribution.  You may ask yourself, what’s so great about this 500mg Ugandan tree bark terpene phenols combined with MCT from coconut oil along with Phyto CBD delivered in a liquid emulsion, great tasting, coffee creamer?  Ten years ago, I would have thought this company was insane.  I mean seriously! Who the hell is going to ingest this crap and why?  But, the market and demographics are very different today than it was ten years ago.  Brands and consumers are much more intricate and complex.  Markets are demanding everything: combining new stuff, old stuff and a combination of this Old World Meets New World fusion of positively charged, chaotic volatileness that will allow us to supersede our mortality and leap tall buildings in a single bound (Superman reference for the Gen Xers like me and older). Okay, maybe not all of that last sentence is true, but hopefully, you get the point.  (This first separation of product brands, we can classify as evolved nutrition.  (I could label it as Millennial Nutrition.  But, I just think that is lame and an overused classification of everything new today.  Plus, I want to respect our new generation of innovators who should be recognized for their creativity, and not for the fact they have reached “adulthood” around the year 2000.)

Picking out cold beverages in the store.At this point, you may be asking, what is the second separation of products brands?  That is an excellent question.  The second separation of goods are the crappy products sold in every grocery chain such as Wal-Mart or other commodity-driven distribution channels.  You know this product, they all have B vitamins in it, some have sprinkles of electrolytes and others hydrate you, presumably better than water.  In the early 2000’s, everyone stopped drinking carbonated soda.  So, they took the carbonation out, added some B vitamins and voila, …we now have healthy soda alternatives that are better than plain water.  I don’t think I even need to go any further than this.  We all know these products, the companies who make them and we are all hopefully gaining an understanding of how crappy most of these products are.

Onto the final and third separation of brands and distribution: milk, yogurts, and juices.  I have a lot of opinions on these.  My first thoughts are directed toward probiotics.  You see, probiotics are living organisms in the form of good bacteria traditionally found in your gut and some fermented foods.  However, many factors such as poor diet, stress, and antibiotics (just to name a few) contribute to low amounts of probiotics produced in your body thus the need for supplementation.

dairy_aisle_shopping_1456105965-gettyimages-506511684Outside of the body probiotic strains are very fragile ingredients to formulate.  Especially since many of them can’t survive processing at high temperatures.  There are a few that have some heat resistance, but most do not tolerate pasteurization or UHT (Ultra High Temperature) processing which is how most yogurts, milk, and juices are made.  Also, I know some probiotics ingredients require frozen storage.  However, these products sold on the market today are, refrigerated at best, definitely not frozen.  Not to mention these products contain water or moisture which are detrimental to the survival rate of some probiotic strains.  At this point you may be asking yourself if the probiotics in raw material form require freezer storage, are sensitive to high heat processing and need to have low moisture, then how can they be incorporated into juices, yogurts, and milk?

One technique to assure stability is to add a ridiculous amount of overage (like 200%) to allow the probiotics to meet the desired specification.  And that is only to make the probiotic survive processing.  Don’t even get me started on shelf life.  I urge anyone one with a micro lab in their house as most of us do, to test for the survivability of probiotics.  I’m confident you all will rush home from work, pull out your cell petri plates then begin growing bacteria with your agar source to study new probiotics and microbiology.  Yeah right!  But let’s say you did have this ability.  If you tested all these products for the term of their shelf-life, what do you think you would find? It might surprise you.  There is a chance it could be something very different than the expected result, and I don’t mean in a good way. I mean in a way where 4 + 4 equals 2, not 8.

At this point, you may be wondering what all three of these product brands and distribution have in common.  My main point is although the nutrition industry is constantly developing products (some good and bad) for the changing markets that doesn’t mean we can overlook the health and quality of the products found in stores all over the world.  Make sure you are partnering with companies that you trust, who have strong ethics towards developing products that are truly healthy and nutritious.  If you do this, you will also ensure your products have adequate amounts of healthy ingredients throughout the entire shelf-life of the finished product.

References:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3813376/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4519473/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3830840/
https://www.ncbi.nlm.nih.gov/pubmed/20629884
https://www.ncbi.nlm.nih.gov/pubmed/21195496