New Safety, Stability Studies on LactoSpore Probiotic

Photo © iStockphoto.com/royaltystockphoto

Hot on the heels of the probiotic ingredient LactoSpore receiving a “no objections” GRAS letter from FDA, Sabinsa (East Windsor, NJ) has shared new safety and stability studies supporting its shelf-stable probiotic. In addition to other recent studies suggesting LactoSpore (Bacillus coagulans MTCC 5856) may provide relief from diarrhea when taken alone and in combination with pharmaceutical drugs, the new research findings indicate LactoSpore is safe for human consumption and remains stable across multiple years of commercial production.

In the first study¹, published in the Journal of Clinical Toxicology, 40 healthy adults aged 18 and older were randomized to consume either LactoSpore or a placebo for 30 days as part of the double-blind, placebo-controlled trial. The LactoSpore group consumed one 600-mg tablet per day, each containing 2 x 10⁹ CFUs of the probiotic. Researchers monitored blood hematology, weight, BMI, blood pressure, heart rate, adverse events, Bristol stool score, tolerability questionnaire, and a bowel habit diary of study participants across the 30-day period.

Researchers found LactoSpore was well tolerated, with a similar number of bowel movements, Bristol stool scores, and mild adverse events observed between the placebo group and the LactoSpore group.

“This study has verified that B. coagulans MTCC 5856 at a dose of 2 x 10⁹ CFU (spores)/day was safe and tolerable in healthy participants when supplemented for 30 days,” researchers concluded.

In a separate study², researchers found that LactoSpore remained stable over multiple years of commercial production. While intra-species genomic diversity can leave B. coagulans strains prone to alteration across years of production, researchers found that the same strain of B. coagulans was present in LactoSpore over three years of commercial production. The study included phenotypic and genotypic testing techniques, including biochemical profiling, BOX PCR fingerprinting, 14S rRNA sequencing, and multi-locus-sequence testing.

Additionally, LactoSpore was found to be non-cytotoxic, non-mutagenic, negative for enterotoxin genes, and stable for 36 months at an ambient temperature of 23 +/- 2 °C.

In a recent press release, Sabinsa celebrated the positive results of this latest research behind LactoSpore, which has now been on the market for more than 20 years.

“The body of science on the safety and efficacy of LactoSpore continues to grow, said Shaheen Majeed, marketing director for Sabinsa. “With the recent ‘no objections’ letter from the U.S. FDA on LactoSpore’s GRAS status, and additional published studies, the demand for LactoSpore continues to surge ahead.”

Majeed also pointed out that LactoSpore’s researched clinical benefits are strain-specific, making them unique to Sabinsa and its customers.

Read more:

LactoSpore Probiotic Remains Stable in Variety of Food Types, Study Says

A 2016 Update: Promising New Science on Probiotics

The World’s First Cranberry Probiotic Peanut Butter Cup?

Michael Crane
Associate Editor
Nutritional Outlook Magazine
michael.crane@ubm.com

References:

1.     Majeed M et al., “A double-blind, placebo-controlled, parallel study evaluating the safety of Bacillus coagulans MTCC 5856 in healthy individuals,” Journal of Clinical Toxicology, vol. 6, no. 1 (February 2016): 283

2.     Majeed M et al., “Evaluation of genetic and and phenotypic consistency of Bacillus coagulans MTCC 5856: a commercial probiotic strain,” World Journal of Microbiology and Biotechnology, vol. 32, no. 4 (February 2016): 60