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Gupta AK, Maity C. Efficacy and safety of Bacillus coagulans LBSC in irritable bowel syndrome: A prospective, interventional, randomized, double-blind, placebo-controlled clinical study. Medicine (Baltimore). 2021;100(3):e23641. View abstract. Results from repeat dose oral toxicity studies in rats from 90 days up to 1 year conducted in compliance with the Organization for Economic Co-operation and Development (OECD) testing guidelines under Good Laboratory Practices (GLP) showed no adverse effects. For instance, in a one-year dietary study in rats, a No Observable Adverse Effect Level (NOAEL) of 1948 mg/kg body weight (bw) per day (equivalent to 134 x 10 9 CFU/kg bw per day), the highest dose tested, was established. In addition, no adverse effects were reported in a one-generation reproductive study (OECD 415) resulting in a NOAEL of 2372 mg/kg bw/day (equivalent to 1.63 x 10 11 CFU/kg bw per day) for the parental generation and 3558 mg/kg bw per day (equivalent to 2.45 x 10 11 CFU/kg bw per day) for the F1 offspring (the highest dose tested). And when you look at some of the data, and we have really good data on the product that’s in our formula called LactoSpore. LactoSpore is a spore based probiotic, and when they did clinical trials, a pilot study but it was a randomized control trial, they found a 42% reduction in bloating and irritable bowel, a 47% reduction in vomiting, a 43% reduction in diarrhea, and a 68% reduction in pain. And even more remarkably, they looked at what happened to the brain because how is the gut and the brain connected? Well, they are very connected through the gut brain connection. And depression went down 57%. Sleep got better 58%, dementia symptoms went down 26%, quality of life went up 47%, along with GI discomfort going down by 62%.
Majeed, M., Majeed, S., Nagabhushanam, K., Natarajan, S., Sivakumar, A., Ali, F., Pande, A., & Karri, S. K. (2016). Evaluation of the stability of Bacillus coagulans MTCC 5856 during processing and storage of functional foods. International Journal of Food Science and Technology, 51(5), 1149-1155. https://doi.org/10.1111/ijfs.13087 Well, thanks Dhru. It’s been a fun class. I think we really always have more to learn about the microbiome, about probiotics, about how to fix the gut, and the exciting part about this era is we’re learning more every day and I’m learning more every day. And I’ve been doing this for 30 years, so it’s pretty exciting. So if you like what you heard on this podcast and you want to learn more about our new multivitamin for your gut called Gut Food, just visit gutfood.com to sign up for the wait list and be sure to share this podcast with your friends and family and we’ll see you next week on The Doctor’s Farmacy.
Evivo. Yeah, doing some really game changing stuff in this space. And there’s plenty of others. There’s our friends Kieran at Microbiome Labs. There’s some friends that you’re connected with at Seed that are also doing some amazing things. It really does feel like we’re in this sort of golden age of people really starting to put the emphasis on probiotics. And it’s less about the competition between all these different people and more about the awareness because we need a lot of different solutions for people at different levels. Gupta RS, Patel S, Saini N, Chen S. Robust demarcation of 17 distinct Bacillus species clades, proposed as novel Bacillaceae genera, by phylogenomics and comparative genomic analyses: description of Robertmurraya kyonggiensis sp. nov. and proposal for an emended genus Bacillus limiting it only to the members of the Subtilis and Cereus clades of species. Int J Syst Evol Microbiol. 2020;70(11):5753-5798. View abstract. Wauters L, Slaets H, De Paepe K, et al. Efficacy and safety of spore-forming probiotics in the treatment of functional dyspepsia: a pilot randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol 2021;6(10):784-792. View abstract.
The Food Directorate has a legislated responsibility for the pre-market assessment of novel foods and novel food ingredients under Division 28 of Part B of the Food and Drug Regulations. The Bacillus coagulans strain MTCC 5856 (LactoSpore®) is considered a novel food under the following part of the definition for novel foods:Czaczyk K, Tojanowska K, Mueller A. Antifungal activity of Bacillus coagulans against Fusarium sp. Acta Microbiol Pol 2002;51:275-83. View abstract.
a valuable addition to any health-conscious individual's regimen. By choosing a high-quality Lactospore-containing supplement and incorporating it into a holistic approach to well-being, you can harness the power of this probiotic and experience the positive effects it has to offer. So one of the first questions that people had Mark on this topic of probiotics is store bought probiotics and things like kombucha and probiotic beverages, are they actually healthy and can they be beneficial to people? Three double-blind, randomized placebo-controlled clinical studies were examined. In these studies, healthy adults (n = 40) or participants with irritable bowl syndrome (n = 36 and 40) received B. coagulans MTCC 5856 at a dose of 2 x 10 9 CFU per day for 30 or 90 days. No safety issues were identified. The results suggest that B. coagulans MTCC 5856 at a dose of 2 x 10 9 CFU per day for up to 90 days is well tolerated. Hey everybody, it’s Dr. Hyman. Welcome to another episode of The Doctor’s Farmacy, and this is a special one because it’s a masterclass where we dive deep into popular health topics, including inflammation, autoimmune disease, brain health, sleep, gut, and more. The B. coagulans MTCC 5856 preparationwas tested to confirm susceptibility to antibiotics. The strain was also shown through genetic sequence analysis to not contain any antimicrobial resistance genes towards clinically relevant antibiotics .Bacillus coagulans MTCC 5856 has been marketed as a dietary ingredient, but its efficacy in diarrhea predominant irritable bowel syndrome (IBS) condition has not been clinically elucidated till date. Thus, a double blind placebo controlled multi-centered trial was planned to evaluate the safety and efficacy of B. coagulans MTCC 5856 in diarrhea predominant IBS patients. Methods Yes. I mean you have to be careful. If you have a tremendous amount of bacteria overgrowth and you take probiotics, you can get worse, just like with fermented foods. But the thing is beautiful. You can start slowly and then build up and it’s sort of kind of win the war over time. I’d like to do the weeding first, but you can actually start to seed and see how that works in a way that actually is a low dose initially, and then you start to build up on the dose and people can generally tolerate it. But it’s often important to treat the underlying issues first. But yes, on the topic of what we’ve been up to with our product Gut Food, and go to gutfood.com and learn a little bit more about it and join the wait list, we thought a deep dive into the topic of probiotics would be a fantastic fit for not just chatting about our product, but answering people’s questions. So Mark, I’m going to take you big picture and just say why do we need probiotics in the first place? And when was the first time that you encountered in your journey and even had heard the term probiotic?
Estimated daily intake (EDI) of 36.4 x 10 9 CFU based on the consumption of 18.2 servings of food per day from USDA data (as reported in GRAS GRN 601) was provided. This EDI is very conservative as it assumes that nearly all food products consumed will contain LactoSpore®, and it is a reasonable approximation to Canadian daily serving intakes based on the available Canadian Community Health Survey data. 4.Chemical Assessment FAO/WHO. Health and nutritional properties of probiotics in food including powder milk with live lactic acid bacteria, Report of a Joint FAO/WHO expert consultation on evaluation of health and nutritional properties of probiotics in food including powder milk with live Lactic acid bacteria. Córdoba, Argentina: 2001. Available at: ftp://ftp.fao.org/docrep/fao/009/a0512e/a0512e00.pdf. Accessed 24 February 2016.AQ7O'Hara, A. M., & Shanahan, F. (2006). The gut flora as a forgotten organ. EMBO Reports, 7(7), 688-693. https://doi.org/10.1038/sj.embor.7400731 Test results were provided for the presence of microbial contaminants in the final spore preparation, specifically Staphylococcus aureus, Salmonella spp., Pseudomonas aeruginosa, coliforms, Escherichia coli, enterobacteriaceae, yeast and mold. All testing was conducted according to USP or FDA-BAM methods. Certificates of analysis for nine production lots demonstrated compliance with these specifications. No safety concerns were found regarding the food use of LactoSpore® from a microbiological perspective. 6.Nutritional Assessment
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