Introduction / Overview

2014-11-07
Introduction / Overview
 Discussion of successful application of the spore‐forming probiotic, Bacillus coagulans in food
 Safety
 Efficacy
 Worldwide regulatory approval
 Advantages over vegetative cells
 Applications impossible for vegetative cells
Stephen T. Quinn, J.D.
International Business and Regulatory Manager, Ganeden Biotech
[email protected] ‐ Booth F21
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What does it mean to be “probiotic” (for food)?
Traditional “Probiotic” Foods
 Per FAO/WHO “live micro‐organisms that when  Kim chi – Korean fermented vegetables
administered in adequate amounts confer a health benefit on the host”
 When the consumer – consumes the food
 The “probiotic” must be safe AT or ABOVE efficacious level
 Health benefits are STRAIN SPECIFIC
 Bacillus coagulans GBI‐30, 6086 (”GanedenBC30")
 Sauerkraut – Traditional fermented cabbage
 Yogurt – Fermented milk
 Natto – Fermented soy beans
 Tempeh – Fermented soy beans
 Kombucha – Fermented tea
 Kefir – Fermented milk
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How “probiotic” are they:
Probiotic traditional food
 CFU per serving
 Of the traditional, unfortified foods, only natto has  Raw significant CFU count
 It traditionally has Bacillus subtilis and/or Bacillus coagulans: both spore forming organisms
 CFU at time of consumption
Sauerkraut: < 1000 CFU per serving
Kim chi: 2,000 CFU per serving
Tempeh: 106,000 CFU per serving
Natto: 2,980,000 CFU per serving
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Probiotic spores
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Safety
 Certain strains of Bacillus coagulans fit the WHO  Bacillus coagulans strains are one of the most common
definition, and are known to be safe
 Food and Chemical Toxicology 47: 1231‐1238. Endres, J.R., et al., 2009.
 Bacillus subtilis, Bacillus clausii also used in foods and  Food Chem Toxicol. 2011 Feb 18, Endres, J., 2011
food supplements, others for animal feed
 Spores have been used in food for at least 50 years, but  Bacillus coagulans is sometimes referred to as Lactobacillus sporogenes, but that name was changed in 1939. Some companies use the outdated name, typically to mislead consumers
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have become more popular in the last 15 years
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Safety
Efficacy
 Spores have been used widely in supplements, but food  Again – STRAIN level; it is not appropriate to attribute safety is subject to different scrutiny
studies even within a species to multiple strains
 Several Bacillus coagulans strains have been show to confer immune, digestive, cholesterol and other benefits
 Efficacy must be demonstrated through:
 US Dept of Health and Human Services GRAS Notice No 000399
 Safety must be shown in toxicity studies including reproductive studies to levels that satisfy food and drug regulators
 Well designed, human clinical trials
 With statistically significant findings
 And published in peer reviewed papers
 As with all things probiotic, safety is strain specific
It is intellectually dishonest to advocate for strain level safety but then accept species level efficacy
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Efficacy examples – immunity and digestion benefits shown
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Accepted as a food ingredient
 Bacillus coagulans significantly improved abdominal pain and bloating in patients  Not all spore formers have been accepted as food with IBS. Postgraduate Medicine 121 (2): 119‐124. Hun, L., 2009.
ingredients
 Effects of a proprietary Bacillus coagulans preparation on symptoms of diarrhea‐
 Some have contraindications for certain populations; most predominant irritable bowel syndrome. Methods Find Exp Clin Pharmacol. 2009 Dec; 31(10):655‐9 Dolin, B.J. 2010
 A patented strain of Bacillus coagulans increased immune response to viral challenge. Postgraduate Medicine 121 (2): 114‐118. Baron, M., 2009.
 A controlled clinical trial to evaluate the effects of GanedenBC30 on immunological markers Methods Find Exp Clin Pharmacol, 32(2) 129‐132 Kimmel M. et al. 2010
 Bacillus coagulans GBI‐30 (GanedenBC30) improves indices of Clostridium difficile‐
induced colitis in mice. Gut Pathogens, 2011, 3:16 Fitzpatrick, L., 2011
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are seriously lacking in strain‐specific data
One strain, GanedenBC30, is approved nearly worldwide:
 US FDA GRAS
 EU QPS for foods
 Non‐objection for AUS/NZ FSANZ
 Approved in Taiwan, India, Philippines, and Japan, Mexico, Venezuela, and Argentina
 Non‐objection with an approved claim from Health Canada
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USP Monograph
Advantages over non‐spores
 The first probiotic to receive a USP monograph published  Survival through the gastric environment to proliferate in in the Food Chemical Codex is Bacillus coagulans GBI‐30, 6086
the gut
 An organism can’t confer benefit if it’s not alive
 Shelf‐stability: up to three years  As of September 2014, Bacillus coagulans GBI‐30,6086 is  Stability through food production processes that would in the Codex. The entry standardizes the identification, handling, reproduction, and enumeration of the organism
be completely inaccessible to vegetative cells
 REMAINS VIABLE to reach its host and confer the intended benefit
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Commercial Advantages over non‐spores
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Survival in the gut
• Advantages of a B. coagulans spore:
 Bacillus coagulans has been shown to survive well in low‐pH • Reduces handling costs
environments and gastric models because of the spore
• Reduces storage costs
 Survives the low pH of the stomach and high pH of bile salts and • Reduces need for large overages
goes on to germinate in the gut when exposed to proper
 Temperature
 Water activity
 Available substrate
• Easier to use
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Acid Tolerance
Survival in food processes
 Viability during gastric transit compared using validated in vitro models have shown spores to be significantly superior survival when exposed to stomach acids and bile salts.
 With spore forming organisms, losses are typically discussed in terms of % loss rather than log loss as is typical with traditional lactic acid cultures
Percentage Loss vs. Log Loss – The Numbers Speak for Themselves
 To be “probiotic” per WHO, the bacteria must be alive when consumed
 Non‐spore probiotics must be stored in temperature‐
controlled environments
 For non‐spore probiotics this limits most strains to refrigerated fermented foods or refrigerated fortified foods
1 log loss: 100,000,000 CFU (10% survival) 10% loss: 900,000,000 CFU (90% survival)
2 log loss: 10,000,000 CFU (1% survival)
20% loss: 800,000,000 CFU (80% survival)
3 log loss: 1,000,000 CFU (.1% survival)
30% loss: 700,000,000 CFU (70% survival)
Baseline = 1 Billion CFU
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Survival in food processes
Successful applications  Bacillus coagulans probiotics can be:
Far beyond fermented food and dairy products
Powders – protein and superfoods
Baked Goods
Hot Beverages
HTST Beverage
HPP Beverage
Confections
Hot‐filled products
Sports products
 Shelf Stable: Sports nutrition, superfood powder, protein
 Heat Stable: Cereal, Hot‐fill liquids, chocolate confections
 Pressure Resistant: HPP juice
 Extruded: Animal feed
 Baked: Pizza crust, cookies, crackers, muffins
 Boiled: Pasta, coffee, tea
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Slide 19
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This slide and the next one need work. Use the slides from the IPA presentation and SHOW examples.
Mike Bush, 10/5/2014
2014-11-07
Application Example: Sports Nutrition and powder blends
Application example: Hot Beverages
 Results in simple, shelf‐stable delivery method
 Dry Mixing has little or no effect on the spore’s survival
 Bacillus coagulans spores will not be harmed by standard  Even after preparation with boiling water, around 80% of mixing or blending equipment
 End‐of‐shelf life survival approaches 100% of inclusion
the spore survives
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Application example: Refrigerated Beverages
Application example: Bars and confections
 Some strains of Bacillus coagulans can survive HTST, HPP,  Bacillus coagulans spores can be put into shelf‐stable or regular hot fill treatments for juice or sparkling beverages
 Depending on specific process, spores can survive in excess of 90%
protein or meal replacement bar products
 Slab bars, hot mix granola, melted chocolate are all viable applications for spores that would kill vegetative cells
 Survival usually more than 80% 23
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Application example: Baked Goods
Conclusions
 Include spores with dry ingredients to ensure even  Well studied and characterized strains of Bacillus coagulans
mixture
 Add wet ingredients, dispense, and bake (no proofing)
 Spores survive at least 60% in most applications
and other SELECT spore‐forming probiotic are a superior ingredients for most food applications
 Safety and efficacy must be studied AT THE STRAIN LEVEL
 Gaining worldwide acceptance by food and drug experts and authorities
 The spore allows the cell to remain viable during gastric transit to proliferate in the gut
 The spore allows the cell to survive food manufacturing processes and actually be alive at the time of consumption
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