title: Evaluation of safety and tolerance of microencapsulated Lactobacillus reuteri NCIMB 30242 in a yogurt formulation: a randomized, placebo-controlled, double-blind study.
abstract: Probiotic organisms have shown promise in treating diseases. Previously, we have reported on the efficacy of microencapsulated Lactobacillus reuteri NCIMB 30242 in a yogurt formulation at lowering serum cholesterol levels in otherwise healthy hypercholesterolemic adults. This study investigates the safety and toxicology of oral ingestion of microencapsulated L. reuteri NCIMB 30242 in a yogurt formulation. A randomized group of 120 subjects received a dose of 5 × 10(10) CFU microencapsulated L. reuteri NCIMB 30242 in yogurt (n=59) or placebo yogurt (n=61) twice/day for 6 weeks. Clinical chemistry and hematological parameters of safety were analyzed. Fecal samples were collected at these time points for the analysis of deconjugated bile acids. The frequency, duration and intensity of adverse events (AEs) and clinical significance of safety parameters were recorded for both groups. No clinically significant differences between the probiotic yogurt and placebo yogurt treated groups were detected in either the blood clinical chemistry or hematology results and there was no significant increase in fecal deconjugated bile acids (P>0.05) between treated and control groups. The frequency and intensity of AEs was similar in the two groups. These results demonstrate the safe use of this formulation in food.
authors.affiliation: Biomedical Technology and Cell Therapy Research Laboratory, Department of Biomedical Engineering, Faculty of Medicine, McGill University, 3775 University Street, Montreal, Quebec, H3A2B4, Canada. mitchell.jones@mcgill.ca
authors.forename: Mitchell L
authors.initials: ML
authors.lastname: Jones
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Martoni
authors.forename: Sandeep
authors.initials: S
authors.lastname: Tamber
authors.forename: Mathieu
authors.initials: M
authors.lastname: Parent
authors.forename: Satya
authors.initials: S
authors.lastname: Prakash
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001647:Bile Acids and Salts / Q000032:analysis; D001772:Blood Cell Count; D001774:Blood Chemical Analysis; D015992:Body Mass Index; D001835:Body Weight; D004311:Double-Blind Method; D004339:Drug Compounding; D005243:Feces / Q000737:chemistry / Q000382:microbiology; D005260:Female; D005285:Fermentation; D006439:Hemodynamics / Q000502:physiology; D006801:Humans; D006937:Hypercholesterolemia / Q000178:diet therapy; D052200:Limosilactobacillus reuteri; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics; D015014:Yogurt / Q000009:adverse effects* / Q000382:microbiology; D055815:Young Adult
chemical_list: D001647:Bile Acids and Salts