A Double-Blind, Placebo-Controlled, Parallel Study Evaluating the Safety of Bacillus coagulans MTCC 5856 in Healthy Individuals

Abstract

Objective: LactoSpore® containing probiotic strain Bacillus coagulans MTCC 5856 has been marketed as a dietary ingredient for nearly two decades. Clinical data on the safety and tolerance has not been evaluated at a dose of 2×109 cfu (spores)/day in healthy individuals. Thus, the primary objective of this study was to investigate the safety and tolerability of B. coagulans MTCC 5856 in healthy adults. Study design: A total of 40 participants were randomized into one of two groups in a double-blind, randomized, placebo-controlled parallel study. One group of participants (n=20) were administered B. coagulans MTCC 5856 (600 mg tablet), containing 2×109 cfu (spores). The control group (n=20) was administered placebo tablets. 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. Results: All laboratory parameters, anthropometric and vital sign measures remained within normal clinical range during the 30 day supplementation. Similar adverse events (AE’s) were reported by participants in both the placebo and the B. coagulans MTCC 5856 group. The number of bowel movements and the Bristol stool scores were similar between the placebo group and B. coagulans MTCC 5856 group during the 30 days of supplementation. Participants also reported that B. coagulans MTCC 5856 tablets were tolerable and easy to swallow. Conclusions: 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.