Journal of Clinical Toxicology
Open Access
ISSN: 2161-0495
+44 1478 350008
ISSN: 2161-0495
+44 1478 350008
Furqan Ali
Sami Labs Limited, 19/1, 19/2, First Main, Second Phase, Peenya Industrial Area, Bangalore-560 058,
Karnataka
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 Majeed
Furqan 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