Is MegaSporeBiotic Safe?

You may be surprised to learn that the majority of probiotic manufacturers never conduct safety or efficacy studies on their probiotics, let alone human clinical trials. Microbiome Labs, maker of MegaSporeBiotic is different. So far, they have completed 14 studies on their proprietary spore blend indicating its safety and efficacy in numerous health conditions. When I worked in the pharmaceutical industry, I helped conduct human clinical trials and I can attest to the immense cost, resources and time it takes to properly conduct these studies.

As a former microbiologist, the big reason I love MegaSporeBiotic is the safety and efficacy results and the studies that have been done on their product. I also value the dedication that Microbiome Labs, the manufacturer of MegaSporeBiotic, has to ongoing research and development.

For over a decade, MegaSporeBiotic probiotic has been the probiotic of choice of more than 30,000 medical doctors, naturopaths, registered nurses, health coaches and other healthcare practitioners. MegaSporeBiotic is also the top selling probiotic at FullScript.com, the leading holistic prescription filler. In the following five sections, you’ll see why this product is so widely prescribed and trusted.

Learn More About MegaSporeBiotic

Cross section depiction of the inside of the colon

Why Use MegaSporeBiotic?

Discover how MegaSporeBiotic targets disease-causing bacteria, supports your immune system, provides nutrients to your gut, keeps its potency through your stomach, and how it benefits your microbiome health.

MegaSporeBiotic Healing Benefits
MegaSporeBiotic bottle front

FAQs for MegaSporeBiotic

Find answers to commonly asked questions about MegaSporeBiotic, including safety, effectiveness, shelf life, side effects, stability during shipping and storage, and usage questions.

MegaSporeBiotic FAQ’s

Natural Gut Residents

Bacillus Spores are Natural Residents of the Human Gut

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Bacillus Licheniformis

Bacillus Licheniformis Species Unique Benefits

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Online Articles & Reviews

Overwhelming evidence for Bacillus Safety

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An Alternative Probiotic

ProFlora 4R is a good alternative to MegaSporeBiotic

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References and Studies

The benefits of Bacillus spores have been well studied

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Cross section depiction of the inside of the colon, Bacillus spores in the gut

Bacillus Spores are Natural Residents of the Human Gut

Bacillus are a type of spore-forming bacteria and many Bacillus species are a natural part of your gut microbiome. Microbiome Labs has carefully selected the exact species of Bacillus from healthy human GI systems. These Bacillus species provide benefits to their human host, as demonstrated by their clinical studies.

There are many species of Bacillus and MegaSporeBiotic was carefully formulated by Microbiologists, Doctors and Researchers with healthy Bacillus species. Each batch of MegaSporeBiotic is rigorously tested to ensure the proper Bacillus species are present and the product meets strict quality control standards.

Bacillus species are present in large numbers in the intestines of animals and humans. Certain Bacillus species act as commensal organisms in humans and animals, meaning they are normal residents of the human gut that provide benefits and minimally don’t cause harm.

Bacillus Licheniformis Species Benefits

MegaSporeBiotic contains the Bacillus licheniformis species, which has many health benefits. Each strain of Bacillus included in the MegaSporeBiotic formula was chosen based on extensive research and guidance from pioneering experts in bacteriotherapy. The concentration of B. licheniformis in MegaSporeBiotic is the smallest of all the strains, with only 50 million CFU of the total 4 billion CFU in the product. The presence of the licheniformis strain, and its concentration, were deliberately and thoughtfully chosen. Humans have been consuming Bacillus licheniformis as long as we have lived on the planet. And this species has been used in many different products for decades.

Arrow and target with bacteria

Infection-Fighting Benefits

B. licheniformis produces the antibiotic bacitracin, which is very effective against disease-causing bacteria in the gut. B. licheniformis also produces a stable protease enzyme vital for digesting and assimilating proteins in the body.

In nature, Bacillus licheniformis is usually found along with B. subtilis and B. coagulans, two other species inside MegaSporeBiotic. Humans have consumed these species together in their food for eons of time. And over the millennia, these Bacillus species because a normal and healthy part of the human gut microbiome. So exposure to these species has become a critical function of our digestive and immune systems. For this reason, MegaSporeBiotic was formulated based on both clinical data and the natural environment. The formulation mirrors the natural balance of these species found in nature.

Proven Safety

MegaSporeBiotic was carefully formulated by a collaboration of microbiologists, doctors, and researchers, with careful attention paid to the safety and scientific rationale of the strains or species used. The safety and effectiveness of the strain in MegaSporeBiotic were selected based on results from in vivo studies and well-documented controlled safety trials.

The Environmental Protection Agency (EPA) performed the most comprehensive safety review on Bacillus licheniformis. The EPA concluded that “B. licheniformis is not a human pathogen nor is it toxigenic. It is unlikely to be confused with related species that are. However, if challenged by large numbers of this microorganism, compromised individuals or those suffering from trauma may be infected”.

In response to cases with adverse events, the EPA and other researchers have reviewed each case of reported illness and have come to the conclusion that B. licheniformis could not be determined to be the causative agent, in the case or simply present in the patient, because the strain is widely found in the natural environment. Furthermore, Nithya et al., with the CSIR-Central Food Technological Research Institute, performed a controlled safety and toxicological study with B. licheniformis and found it “safe for food industry applications.”

Bacillus licheniformis is a Generally Recognized as Safe (GRAS) organism in the United States by the Food and Drug Administration (FDA) standard for safety and toxicity of bacterial strains and has Qualified Presumption of Safety (QPS) designation in the European Union (EU). To date, there is not a single case report where B. licheniformis was determined to be the primary causative agent in an infection and all case reports of adverse events are in subjects that are severely immunocompromised and/or had significant trauma.

Scientific Studies in Context

Determining the safety of a product cannot be scientifically done based on a small number of uncontrolled case studies. This is especially true when important variables are not accounted for. Even large and well-controlled studies can be very misleading and produce incorrect results, depending on the methods used in the study and the type of statistics used to gauge the results.

Every scientific study showing a link between a specific species and an illness must be carefully evaluated to determine if the species of concern is the true causative agent. If so, the outlying factors must be identified.

Fortunately, numerous researchers have reviewed cases resulting in adverse events with the use of B. licheniformis. After reviewing these published studies it was determined that in none of the cases was B. licheniformis the causative agent. Additionally, all cases were reported having included individuals who were severely immunocompromised or with trauma. Bacillus licheniformis was never determined to be the actual cause of infection.

Question marks - looking for answers

Online Articles and Reviews

Both positive and negative online reviews may be found for nearly any supplement, and the same is true for MegaSporeBiotic. Michelle Moore is a strong advocate that knowledge is power and you will achieve the best results with your health be knowing all that you can about your body and what you put into it. So doing your own research is crucial and highly encouraged. But sifting through the internet for honest and accurate information about a supplement can be a big challenge.

It’s even more challenging if you’re unfamiliar with the product, new to natural medicine, or unaware of the limitations of online information. Internet search engines like Google usually highlight negative search results for natural health topics and downplay any positive results. So the search results you get are unevenly biased toward negative webpages. Search engines such as Brave.com do a much better job of showing balanced and honest search results for natural health topics. But even so, determining if a website is trustworthy or not can take some time and effort.

If you lack the time or the ability to do thorough research for yourself, then it’s crucial to select products from a trusted source. Your trusted local holistic or natural doctor is an excellent source for probiotics and other supplements. Michelle has also attempted to make the process of finding safe and effective probiotics easier for you on this website.

Misleading Claims

There are at least three websites making claims that MegaSporeBiotic and spore-based probiotics in general are unhealthy and dangerous. At best, their basis for these false claims is thin and based on incorrect conclusions drawn from small studies. Two of these websites sell their own brand of probiotics.

Unfortunately, it’s a well known marketing tactic to dishonestly discredit a popular competitor’s product in order to sell more of your own product. It’s important to look for the data being used to either support a product or to discredit it. In the case of MegaSporeBiotic, the overwhelming scientific evidence and clinical success showing the safety of Bacillus spores far outweigh the few misleading and biased naysayers found online.

An Alternative Spore Probiotic

The ProFlora 4R product has similar strains as compared to MegaSporeBiotic, but without the Bacillus licheniformis species. ProFlora 4R also contains added herbal ingredients to reduce the risk of potential gut discomfort and to reduce any mild constipation that some experience with probiotics.

ProFlora 4R contains three clinically researched strains of Bacillus probiotics plus healing herbal cofactors inside one broad-spectrum probiotic formulation. Now with 33% more spores.

This professional strength probiotic is an ideal addition to an immune support regimen during active bacterial challenges or for long-term gut microbiome support. A great addition to your immune-boosting protocol for support with seasonal challenges.*

Proflora 4R product bottle front

Probiotic Comparison

What’s the difference between MegaSporeBiotic, RestorFlora, Proflora 4R and HU58?

We offer four different probiotic products – each one ideally suited for different kinds of support. If you’re unsure which probiotic is best for you, then use our decision tree to help you choose the best products to fit your unique needs, along with the help of a holistic or natural healthcare professional. And if you’re unsure how our probiotics compare with each other, then use our comparison table to help you see the differences.

Probiotic Comparison
MegaSporeBiotic with Pills

References and Studies

Below is a list of studies on Bacillus spores, which are found inside MegaSporeBiotic, RestorFlora and HU58. Bacillus spores and the Saccharomyces boulardii species have been used safely for decades in probiotic products around the world and they are not new to the Microbiome Labs products. Also note that while scientific studies are important, it’s equally important that a food, supplement or ingredient have a long history of safe and effective use in day to day clinical settings between real doctors and their patients.

Fortunately, there has been much research on Bacillus spores in general and on MegaSporeBiotic in particular. But just as important and valuable are the real-world effects that this and other products are having in people.

General References

The following references on probiotics, Bacillus spores and Saccharomyces boulardii come from chapter 4 of Michelle’s book C. difficile Treatment & Remedies

  1. A framework for human microbiome research, The Human Microbiome Project Consortium, Nature 486, 215–221 (14 June 2012).
  2. Host-Pathogen Interactions: the seduction of molecular cross talk, J. Gut 2002;50:32.
  3. Recommendations for probiotic use – Floch et al, J Clin Gastroenterol. 2008 Jul.
  4. Probiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children, Joshue Z Goldenberg et al, 31 MAY 2013 The Cochrane Library.
  5. Timely Use of Probiotics in Hospitalized Adults Prevents Clostridium difficile Infection: A Systematic Review With Meta-Regression Analysis. Shen NT et al. Gastroenterology. 2017 Jun;152(8):1889-190.
  6. Validating bifidobacterial species and subspecies identity in commercial probiotic products, Lewis ZT, Pediatr Res. 2016 Mar;79(3):445-52.
  7. Pathogen elimination by probiotic Bacillus via signalling interference. Pipat P., Yue Z., Thuan N., Seth D. et el. Nature, 2018. Chapter 14 – Probiotics 201.
  8. Oral spore-based probiotic supplementation was associated with reduced incidence of post-prandial dietary endotoxin, triglycerides, and disease risk biomarkers. Brian K McFarlin. World J Gastrointest Pathophysiol 2017 August 15; 8(3): 117-126.
  9. Bacillus Coagulans GBI-30 (BC30) improves indices of Clostridium difficile-Induced colitis in mice. Fitzpatrick L, Small J, Greene W, Karpa K, Keller D. Gut Pathog. 2011; 3: 16.
  10. Bacillus coagulans GBI-30, 6086 limits the recurrence of Clostridium difficile-Induced colitis following vancomycin withdrawal in mice. Fitzpatrick L, Small J, Greene W, Karpa K, Farmer S, Keller D. Gut Pathog. 2012; 4: 13.
  11. Probiotics for Prevention of Clostridium difficile Infection. Mills J, Rao K, Young V. Curr Opin Gastroenterol. 2018 Jan; 34(1): 3–10.
  12. Secreted Compounds of the Probiotic Bacillus clausii Strain O/C Inhibit the Cytotoxic Effects Induced by Clostridium difficile and Bacillus cereus Toxins. Ripert G. et al. Antimicrob Agents Chemother. 2016 Jun; 60(6): 3445–3454.
  13. Probiotic strain Bacillus subtilis CU1 stimulates immune system of elderly during common infectious disease period: a randomized, double-blind placebo-controlled study. Lefevre M, Racedo SM, Ripert G, et al. Immun Aging. 2015;12:24.
  14. A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease. McFarland LV, Surawicz CM, Greenberg RN, Fekety R, Elmer GW. JAMA. 1994 Jun 22-29;271(24):1913-8.
  15. A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease, McFarland LV, JAMA 1994 Jun 22-29; 271(24):1913-8.
  16. Saccharomyces boulardii inhibits Clostridium difficile toxin A binding and enterotoxicity in rat ileum. Pothoulakis et al, Gastroenterology. 1993 Apr;104(4):1108-15.
  17. Probiotics in the prevention of antibiotic-associated diarrhoea and Clostridium difficile infection. Hickson M. Therap Adv Gastroenterol. 2011 May; 4(3): 185–197.
  18. Saccharomyces boulardii Stimulates Intestinal Immunoglobulin A Immune Response to Clostridium difficile Toxin A in Mice. Qamar et al, Infect Immun. 2001 Apr; 69(4): 2762–2765.
  19. Saccharomyces boulardii protease inhibits Clostridium difficile toxin A Chapter 14 – Probiotics 202 effects in the rat ileum. Castagliuolo et al. Infect Immun. 1996 Dec;64(12):5225-32.
  20. Review article: Anti-inflammatory mechanisms of action of Saccharomyces boulardii. Pothoulakis, C. Aliment Pharmacol Ther. 2009 Oct 15; 30(8): 826–833.
  21. Effect of biotherapeutics on cyclosporin-induced Clostridium difficile infection in mice. Kaur et al. J Gastroenterol Hepatol. 2010 Apr;25(4):832-8.
  22. Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R, and Lactobacillus rhamnosus CLR2 (Bio-K+): Characterization, Manufacture, Mechanisms of Action, and Quality Control of a Specific Probiotic Combination for Primary Prevention of Clostridium difficile Infection. Auclair et al. Clinical Infectious Diseases, Volume 60, Issue suppl_2, 15 May 2015, Pages S135–S143.

Bacillus References

The following references include Bacillus probiotic species.

  • Defining the natural habitat of Bacillus spore-formers, Huynh A. Hong et el, Research in Microbiology 160 (2009) 375e379
  • Bacillus probiotics – Mechanism of action and use. Simon M. Cutting, Professor of Molecular Microbiology, School of Biological Sciences, Royal Holloway, University of London. Protexin Healthcare.
  • The use of bacterial spore formers as probiotics, FEMS Microbiology Reviews 29 (2005) 813–835
  • The safety of Bacillus subtilis and Bacillus indicus as food probiotics, Journal of Applied Microbiology ISSN 1364-5072
  • The Intestinal Life Cycle of Bacillus subtilis and Close Relatives, JOURNAL OF BACTERIOLOGY, Apr. 2006, p. 2692–2700 Bacillus probiotics, Food Microbiology 28 (2011) 214e220
  • Characterization of Bacillus Species Used for Oral Bacteriotherapy and Bacterioprophylaxis of Gastrointestinal Disorders, APPLIED AND ENVIRONMENTAL MICROBIOLOGY, 0099-2240/00/$04.0010, Dec. 2000, p. 5241–5247
  • Bacillus Probiotics: Spore Germination in the Gastrointestinal Tract, APPLIED AND ENVIRONMENTAL MICROBIOLOGY, May 2002, p. 2344–2352
  • Pathogen elimination by probiotic Bacillus via signalling interference, https://doi.org/10.1038/s41586-018-0616-y
  • Bacillus subtilis antibiotics: structures, syntheses and specific functions, Molecular Microbiology (2005) 56(4), 845–857
  • Immunostimulatory activity ofBacillus spores, FEMS Immunol Med Microbiol 53 (2008) 195–203
  • Efficacy of Bacillus clausii spores in the prevention of recurrent respiratory infections in children: a pilot study, Therapeutics and Clinical Risk Management 2007:3(1) 13–17
  • Effect of Bacillus subtilis spore administration on activation of macrophages and natural killer cells in mice, Veterinary Microbiology 60 1998 215–225
  • The effect of Probiotic Bacillus subtilis HU58 on Immune function in Healthy Human, The Indian Practitioner q Vol.70 No.9. September 2017

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