Safety assesment of Bacillus clausii UBBC07, a spore forming probiotic

Abstract

Probiotics are vital bacteria that colonize the intestine and modify its microflora with benefits for the host. Very few members of the Bacillus group are recognized as safe for use and hence only a few strains are available as commercial preparations for application in humans and animals. Acute and subacute studies in rats were conducted to establish safety of Bacillus clausii (B. clausii) UBBC07. In the acute toxicity study, the oral LD50 for B. clausii UBBC07 was found to be >5000 mg/kg (630 billion cfu/kg) body weight. The NOAEL for B. clausii UBBC07 was found to be 1000 (126 billion cfu) mg/kg body weight/day by oral route in the subacute toxicity study. There were no significant differences between control and treated groups in any of the endpoints assessed using an OECD443 or OECD407 protocol.B. clausii UBBC07 was found to be resistant to three antibiotics −clindamycin, erythromycin and chloramphenicol. Analysis of the whole genome sequence of B. clausii UBBC07 revealed that the antibiotic resistance genes are present in chromosomal DNA which is intrinsic and not transferable. Toxin genes were also found to be absent. These results suggest consumption of B. clausii UBBC07 is safe for humans.

Anti-microbial susceptibility pattern of spores used in Bacillus clausii suspension: an in vitro study

“…These results suggest consumption of B. clausii is safe for humans. 27 In conclusion, resistant traits found in B. clausii spore suspension (Benegut®) in our study were similar to those reported from other commercial preparations of Bacillus strains. Benegut® can be a useful source of improving the intestinal imbalance of microbial flora; and effective treatment of diarrhea and other intestinal malfunctions.…”

“…25 Analysis of the whole genome sequence of B. clausii has revealed that the antibiotic resistance genes are present in chromosomal DNA which is intrinsic and not transferable. 27 Toxin genes were also found to be absent. These results suggest consumption of B. clausii is safe for humans.…”

Microbiological evaluation of infant foods quality and molecular detection of Bacillus cereus toxins relating genes

“…B. cereus was among the primary microbes associated with baby food contamination as reported by FAO/WHO Expert Consultations [ 7 ]. In spite of that B. cereus was classified as category C or of low risk, its prevalence in infant food was sufficiently high to cause food borne infection outbreaks [ 8 , 9 ]. B. cereus spores are resistant to many processes as low and high temperatures, desiccation, disinfectant agents, ionization, radiation and ultraviolet light [ 10 , 11 ].…”

Survival and Germination of Bacillus clausii UBBC07 Spores in in vitro Human Gastrointestinal Tract Simulation Model and Evaluation of Clausin Production

“…Bacillus clausii UBBC07 (MTCC 5472) is a Gram-positive, spore-forming, motile, rod-shaped, non-toxic, and safe probiotic bacterium (Lakshmi et al, 2017) available commercially in the form of spore-suspension and dry formulations in India. Clinically, the consumption of UBBC07 [2 × 10 9 colony-forming unit (CFU)] capsule (twice a day) for 10 days was found to be safe and effective to alleviate the symptoms of acute diarrhea in adults (Sudha et al, 2013).…”