Safety assesment of Bacillus clausii UBBC07, a spore forming probiotic. (2017)

• Record Type: Journal Article
• Authors: Lakshmi, Suvarna G.; Jayanthi, N.; Saravanan, M.; Ratna, M. Sudha
• Is Part Of: Toxicology reports. Volume 4(2017)
• Page Start: 62
• Page End: 71
• Publication Date: 2017
• Subjects: NOAEL no observed adverse effect level -- B. clausii UBBC07 Bacillus clausii UBBC07 -- Hgb hemoglobin -- Hct hematocrit -- RBC red blood cell -- WBC white blood cell -- RET reticulocyte -- MCV mean corpuscular volume -- MCH mean corpuscular hemoglobin -- MCHC mean corpuscular hemoglobin concentration -- ALT alanine aminotransferase -- AST aspartate aminotransferase -- TP total protein -- Alb albumin -- ALT alanine amino transferase -- Glu glucose -- T.chol total cholesterol -- Creat creatinine -- ALP alanine amino phosphate -- T.Bil total bilirubin -- Glob globulin -- Trig triglycerides -- BUN blood urea nitrogen -- Vol volume -- SG specific gravity -- Pro protein -- Leu leucocytes -- Ery erythrocytes -- EC epithelial cells -- C casts -- GC granular casts -- Cry crystals -- TPC triple phosphate crystals; Acute toxicity -- Subacute toxicity -- NOAEL -- Bacillus clausii UBBC07 -- Whole genome; Toxicology -- Periodicals; Clinical toxicology -- Periodicals; Drug-Related Side Effects and Adverse Reactions; Hazardous Substances; Poisoning; Toxicology; Electronic journals; Periodicals; Periodicals; 571.9505
• DOI: 10.1016/j.toxrep.2016.12.004
• Languages: English
• ISSNs: 2214-7500

Abstract

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.