Evaluation of safety and tolerance of microencapsulated Lactobacillus reuteri NCIMB 30242 in a yogurt formulation: A randomized,placebo-controlled,double-blind study |
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Authors: | Mitchell L. Jones Christopher J. Martoni Sandeep Tamber Mathieu Parent Satya Prakash |
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Affiliation: | Biomedical Technology and Cell Therapy Research Laboratory, Department of Biomedical Engineering, Physiology and Artificial Cells and Organs Research Centre, Faculty of Medicine, McGill University, 3775 University Street, Montreal, Quebec, H3A 2B4, Canada |
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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 × 1010 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. |
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Keywords: | AE, adverse events ALT, alanine transaminase APA, alginate-poly-l-lysine AlkP, alkaline phosphatase AST, aspartate aminotransferase Bpm, beats per minute BSH, bile salt hydrolase BMI, body mass index Ca2+, calcium Cl&minus , chloride CSV, clinically significant value GGT, gamma-glutamyl transpeptidase ICH&ndash GCP, International Conference on Harmonization &ndash Good Clinical Practice LAB, lactic acid bacteria N, number of subjects ANOVA, one-way analysis of variance PRO, patient-reported outcome PO43&minus , phosphate K+, Potassium QC, quality control QPS, qualified presumption of safety Na+, sodium SOP, standard operating procedures |
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