title: One-year chronic oral toxicity with combined reproduction toxicity study of a novel probiotic, Bacillus coagulans, as a food ingredient.
abstract: Some strains of Bacillus coagulans can survive extremes of heat, stomach acid and bile acids, to which commonly consumed probiotics are susceptible. A toxicological safety assessment was published in 2009 on a proprietary preparation of B. coagulans - GanedenBC(30)™ - a novel probiotic. It was concluded that GanedenBC(30)™ is safe for chronic human consumption based upon scientific procedures, supported by a safe history of use (Endres et al., 2009). A one-year chronic oral toxicity study combined with a one-generation reproduction study was conducted to further investigate safety of long-term consumption. The one-year study of GanedenBC(30)™ administered to male and female HsdBrlHan: Wistar rats in their diet showed no signs of toxicity at the highest dose tested. The conclusion from the reproduction toxicity study is that administration of GanedenBC(30)™ in the diet caused no signs of toxicity in the parental generation (male or female) nor the F1 offspring. Using the lowest NOEL of 1948 mg/kg concluded at the end of the 1-year feeding study, a 100-fold safety factor, a test article concentration of 6.88×10(10) CFU (colony forming units) per gram, and an average 70 kg human, it is determined that GanedenBC(30)™ is safe for chronic consumption at up to 9.38×10(10) CFUs per day.
authors.affiliation: AIBMR Life Sciences, Inc., 4117 South Meridian, Puyallup, WA 98373, USA. john@aibmr.com
authors.forename: J R
authors.initials: JR
authors.lastname: Endres
authors.forename: I
authors.initials: I
authors.lastname: Qureshi
authors.forename: T
authors.initials: T
authors.lastname: Farber
authors.forename: J
authors.initials: J
authors.lastname: Hauswirth
authors.forename: G
authors.initials: G
authors.lastname: Hirka
authors.forename: I
authors.initials: I
authors.lastname: Pasics
authors.forename: A G
authors.initials: AG
authors.lastname: Schauss
mesh_terms: D000284:Administration, Oral; D000818:Animals; D001407:Bacillus; D003257:Consumer Product Safety; D004032:Diet; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D005260:Female; D005504:Food Analysis; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D019936:Probiotics / Q000633:toxicity*; D051381:Rats; D017208:Rats, Wistar; D012098:Reproduction / Q000187:drug effects*; D036401:Toxicity Tests, Chronic