Sabinsa’s shelf-stable LactoSpore^® probiotic has been extensively researched in the 20 years since it was introduced, and recently several new studies, including clinical studies, have been published. Areas researched include safety and tolerability, shelf life stability, genetic and phenotypic stability, and anti-diarrheal activity, all with positive and significant results.

LactoSpore^®: Anti-diarrheal & Gastrointestinal motility study (International Journal of Pharma and Biosciences. 7 (1): 311-16. 2016)
The effect of Bacillus coagulans MTCC 5856 (LactoSpore^®) on castor oil induced diarrhoea and gastrointestinal (GI) motility using well established in vivo studies found LactoSpore^® exerted dose dependent anti- diarrhea activity and reduced the faecal output (33%). It also inhibited the gastrointestinal motility. The results suggested that LactoSpore^® possess significant anti-diarrheal activity and therefore could be a potential agent in the management of diarrhea.

LactoSpore^® in treatment of diarrhea predominant IBS study (Nutrition Journal.15:21. 2016)
A double blind placebo controlled multi-centered trial was conducted to evaluate the safety and efficacy of LactoSpore^® in diarrhea predominant Irritable Bowl Syndrome(IBS) patients. Thirty-six newly diagnosed diarrhea predominant IBS patients were enrolled in three clinical centers. Along with standard care of treatment, 18 patients in group one received placebo while in group two, 18 patients received LactoSpore^® for 90 days.

Laboratory parameters, anthropometric and vital signs were within the normal clinical range during the 90 days of supplementation in placebo and LactoSpore^® groups. There was a significant decrease in the clinical symptoms like bloating, vomiting, diarrhea, abdominal pain and stool frequency in the patient group receiving LactoSpore^® when compared to placebo group (p < 0.01). Similarly, disease severity also decreased and the quality of life increased in the patient group compared to placebo group.

The study concluded that LactoSpore^® along with standard care of treatment was found to be safe and effective in diarrhea predominant IBS patients for 90 days of supplementation. Hence, LactoSpore^® could be a potential agent in the management of diarrhea predominant IBS patients.

LactoSpore^®: Genetic and Phenotypic Consistency Findings (World Journal of Microbiology and Biotechnology 32:60. 2016)
That B. coagulans strain is stable over multiple years of commercial production was clearly demonstrated through this study designed to evaluate probiotic potential, in-vitro safety, product stability, genetic and phenotypic consistency of the probiotic strain used for production of LactoSpore^®. Phenotypic and genotypic studies proved that the commercial preparations of LactoSpore^® contained the same strain of B. coagulans  MTCC 5856 over multiple years of commercial production. B. coagulans  MTCC 5856 strain showed probiotic potential and found to be non-mutagenic, non-cytotoxic, negative for enterotoxin genes and stable at ambient temperature (25 ± 2°C) for 36 months. Findings of this study provide confidence to use B. coagulans  MTCC 5856 as a probiotic ingredient in various dietary and functional foods and health products.

LactoSpore^® Safety Study (Journal of Clinical Toxicology 6: 283. 2016)
A Double-Blind, Placebo-Controlled, Parallel clinical trial was conducted to evaluate the Safety and tolerability of B. coagulans MTCC 5856 at a dose of 2 billion spores per day in healthy adults. Safety and tolerability of  B. coagulans MTCC 5856 was assessed over 30 days by safety laboratory parameters (blood hematology and clinical chemistry parameters), anthropometric measures (weight, BMI, blood pressure and heart rate), adverse events, Bristol stool score, tolerability questionnaire and bowel habit diary. 

All laboratory parameters, anthropometric and vital sign measures remained within normal clinical range during the 30-day supplementation. There were no between group differences in bowel movements and the Bristol stool scores for participants in the placebo vs B. coagulans MTCC group during the 30 days of supplementation. Participants also reported that B. coagulans MTCC 5856 tablets were tolerable and easy to swallow.  This study has verified that B. coagulans MTCC 5856 at a dose of 2 × 10⁹ cfu (spores)/day was safe and tolerable in healthy participants when supplemented for 30 days. The study was conducted by an independent CRO on subjects from North American population and the study protocol was reviewed by NHPD, Canada.

LactoSpore^® has recently obtained the approval as Natural Health Product (NHP) that allows formulators and marketing companies to market LactoSpore^® in Canada as NHP.  This approval renders Canadian market readily accessible by US and Canadian marketing companies. Pre-approved NHP ingredients can reduce the review period of Product license application in Canada, where a pre-market approval system precedes actual marketing. LactoSpore^®’s approval in natural health products in Canada is also supported by Sabinsa’s Utah facility, a registered foreign site for manufacturing the NHP for the Canadian market.

“The body of science on the safety and efficacy of LactoSpore^® continues to grow,” said Shaheen Majeed, Sabinsa Marketing Director. “With the recent “no questions” letter from the US FDA on LactoSpore^®’s GRAS status, and additional published studies, the demand for LactoSpore^® continues to surge ahead. The clinical benefits on Sabinsa’s LactoSpore^® is strain specific, and therefore one of kind to Sabinsa and to our customers.”