title: Safety evaluation of AB-LIFE(®) (Lactobacillus plantarum CECT 7527, 7528 and 7529): Antibiotic resistance and 90-day repeated-dose study in rats.
abstract: AB-LIFE(®) is a probiotic product consisting of equal parts of three strains of Lactobacillus plantarum (CECT 7527, 7528, and 7529) blended with inert excipients. Whole genome sequencing was performed on each of the three strains. Antibiotic resistance was evaluated by genomic mining for resistance genes, and assessment for transferability. No risk of transfer potential was identified for any antibiotic resistance genes in the three strains. AB-LIFE(®) was evaluated for potential subchronic oral toxicity in rats, with dosages of 300 and 1000 mg/kg BW/day (equivalent to 5.55 × 10(10) and 1.85 × 10(11) CFU/kg BW/day). Survival of the three test strains through the gastrointestinal tract was supported by fecal analysis. No adverse effects were identified with respect to in-life parameters, clinical or anatomic pathology, translocation, or fecal chemical analyses. The no-observed-adverse-effect level (NOAEL) for AB-LIFE(®) in male and female rats was 1000 mg/kg BW/day (1.85 × 10(11) CFU of AB-LIFE(®)/kg BW/day), the highest dose level evaluated. These results, in conjunction with a previous acute toxicity study in rats, support the conclusion that AB-LIFE(®) is safe for human consumption.
authors.affiliation: DuPont Stine-Haskell, Newark, DE, USA.
authors.forename: Pushkor
authors.initials: P
authors.lastname: Mukerji
authors.affiliation: DuPont Stine-Haskell, Newark, DE, USA. Electronic address: Jason.Roper-1@dupont.com.
authors.forename: Jason M
authors.initials: JM
authors.lastname: Roper
authors.affiliation: DuPont Nutrition and Health, Madison, WI, USA.
authors.forename: Buffy
authors.initials: B
authors.lastname: Stahl
authors.affiliation: DuPont Nutrition and Health, Madison, WI, USA.
authors.forename: Amy B
authors.initials: AB
authors.lastname: Smith
authors.affiliation: DuPont Stine-Haskell, Newark, DE, USA.
authors.forename: Frank
authors.initials: F
authors.lastname: Burns
authors.affiliation: DuPont Stine-Haskell, Newark, DE, USA.
authors.forename: Jessica Caverly
authors.initials: JC
authors.lastname: Rae
authors.affiliation: DuPont Nutrition and Health, Kantvik, Finland.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Yeung
authors.affiliation: DuPont Nutrition and Health, Kantvik, Finland.
authors.forename: Anna
authors.initials: A
authors.lastname: Lyra
authors.affiliation: DuPont Nutrition and Health, Kantvik, Finland.
authors.forename: Laura
authors.initials: L
authors.lastname: Svärd
authors.affiliation: DuPont Nutrition and Health, Kantvik, Finland.
authors.forename: Markku T
authors.initials: MT
authors.lastname: Saarinen
authors.affiliation: Avoltus Oy, Turku, Finland.
authors.forename: Esa
authors.initials: E
authors.lastname: Alhoniemi
authors.affiliation: DuPont Nutrition and Health, Kantvik, Finland.
authors.forename: Alvin
authors.initials: A
authors.lastname: Ibarra
authors.affiliation: DuPont Nutrition and Health, Kantvik, Finland.
authors.forename: Arthur C
authors.initials: AC
authors.lastname: Ouwehand
mesh_terms: D000284:Administration, Oral; D000818:Animals; D004352:Drug Resistance, Microbial / Q000235:genetics*; D005243:Feces / Q000737:chemistry / Q000382:microbiology*; D005260:Female; D041981:Gastrointestinal Tract / Q000187:drug effects*; D015964:Gene Expression Regulation, Bacterial / Q000187:drug effects*; D005798:Genes, Bacterial / Q000235:genetics; D023281:Genomics / Q000379:methods; D059014:High-Throughput Nucleotide Sequencing / Q000379:methods; D006801:Humans; D048191:Lactiplantibacillus plantarum / Q000502:physiology*; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D019936:Probiotics / Q000633:toxicity*; D051381:Rats; D012449:Safety; D059550:Toxicity Tests, Subchronic / Q000379:methods*
keywords: Lactobacillus plantarum; Probiotic; Rats; Subchronic toxicity