A Double-Blind, Placebo-Controlled, Parallel Study Evaluating the Safety of Bacillus coagulans MTCC 5856 in Healthy Individuals Muhammed Majeed 1,2 , Kalyanam Nagabhushanam 2 , Sankaran Natarajan 1 , Arumugam Sivakumar 1 , Anurag Pande 2 , Shaheen Majeed 2,3 and Furqan Ali 1* 1 Sami Labs Limited, 19/1 & 19/2, First Main, Second Phase, Peenya Industrial Area, Bangalore-560 058, Karnataka, India 2 Sabinsa Corporation, 20 Lake Drive, East Windsor, NJ 08520 3 Sabinsa Corporation, 750 Innovation Circle, Payson, UT 84651, USA * Corresponding author: Furqan Ali, Sami Labs Limited, 19/1, 19/2, First Main, Second Phase, Peenya Industrial Area, Bangalore-560 058, Karnataka, India, Tel: +91 80 2839 7973; Fax: +91 80 2837 3035; E-mail: furqan@samilabs.com Received date: January 22, 2016; Accepted date: February 19, 2016; Published date: February 28, 2016 Copyright: © 2016 Majeed M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. 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 2×10 9 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 2×10 9 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 × 10 9 cfu (spores)/day was safe and tolerable in healthy participants when supplemented for 30 days. Keywords: Bacillus coagulans MTCC 5856; Gut microbiota; LactoSpore®; Probiotic; Safety; Tolerability Introduction Intestinal microbiota plays a crucial role in several metabolic processes such as the regulation of intestinal epithelial proliferation, gut maturation, colonization, and resistance and modulation of the intestinal immune response [1-4]. Te intestinal metabolome is composed of diferent species of benefcial and pathogenic bacteria. Benefcial bacterial species have several crucial functions in the intestine; restraining potentially pathogenic or harmful bacteria, activating immune responses, aiding proper digestion and absorption of food and acting as a barrier against harmful bacteria and toxins [5]. More than 500 species of indigenous bacteria colonize the colon and play a crucial role in human health and disease. In healthy individuals, the gut microbiota act as an important modulator of the immune system and serve as a source of non-infammatory immune stimulation [6]. Modern lifestyle factors such as a poor diet, frequent travel and food or water contaminants in combination with increasing age may disturb the delicate balance of intestinal bacteria. Furthermore, medications such as broad spectrum antibiotics are commonly prescribed to curb infection which unfortunately kills benefcial bacteria disrupting the balance between the non-pathogenic and pathogenic species [7]. Probiotics are microorganisms that when administered in adequate amount provide health beneft to the host organism [8]. Tey induce health benefts by altering the intestinal microecology, producing antimicrobial compounds, and stimulating the body’s immune response. Preparations of Bacillus coagulans has been found to contain a large number of viable lactic acid bacilli that retain their viability during storage prior to consumption as the spores are thermostable, survive in gastric secretions, reach and settle in the intestine producing sufcient lactic acid and other antagonistic substances inhibiting the growth of pathogenic bacteria. In vitro and in vivo studies on oral toxicity attest to the safety of B. coagulans [9,10]. B. coagulans is a probiotic, well known for its clinical efcacy in several human conditions [9-14]. B. coagulans based products are efcacious in adults with post-prandial intestinal discomfort, improving their quality of life. A potential for its application in adults with irritable bowel syndrome (IBS) have shown promising results in this arena [11,12,14]. Researchers have also reported on the relationship between B. coagulans and the immune system [15,16]. It is a well-established fact that the health benefts and the safety of a probiotic strain is strain specifc, and not the species or genus-specifc. Tis was clearly Majeed, et al., J Clin Toxicol 2016, 6:1 DOI: 10.4172/2161-0495.1000283 Research Article open access J Clin Toxicol ISSN:2161-0495 JCT, an open access Volume 6 • Issue 1 • 1000283 J o u r n a l o f C li n i c a l T o x i c o l o g y ISSN: 2161-0495 Journal of Clinical Toxicology