Journal of Clinical Toxicology
Open Access
ISSN: 2161-0495
ISSN: 2161-0495
Muhammed Majeed
India
Research Article
A Double-Blind, Placebo-Controlled, Parallel Study Evaluating the Safety of
Bacillus coagulans MTCC 5856 in Healthy Individuals
Author(s): Furqan Ali, Muhammed Majeed, Kalyanam Nagabhushanam, Sankaran Natarajan, Arumugam Sivakumar, Anurag Pande and Shaheen MajeedFurqan Ali, Muhammed Majeed, Kalyanam Nagabhushanam, Sankaran Natarajan, Arumugam Sivakumar, Anurag Pande and Shaheen Majeed
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 .. View More»
DOI:
10.4172/2161-0495.1000283