Evaluation of safety and tolerance of microencapsulated Lactobacillus reuteri NCIMB 30242 in a yogurt formulation: A randomized, placebo-controlled, double-blind study

• Published in: Food and chemical toxicology Vol. 50; no. 6; pp. 2216 - 2223
• Main Authors: Jones, Mitchell L., Martoni, Christopher J., Tamber, Sandeep, Parent, Mathieu, Prakash, Satya
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.06.2012; Elsevier
• Subjects: Adolescent; Adult; adults; Adverse events; Aged; Bile acids; Bile Acids and Salts - analysis; Bile salt hydrolase; Biological and medical sciences; Blood Cell Count; Blood Chemical Analysis; blood serum; Body Mass Index; Body Weight; chemistry; cholesterol; Double-Blind Method; Drug Compounding; feces; Feces - chemistry; Feces - microbiology; Female; Fermentation; hematology; Hemodynamics - physiology; Humans; hypercholesterolemia; Hypercholesterolemia - diet therapy; ingestion; Lactobacillus; Lactobacillus reuteri; Male; Medical sciences; Microencapsulation; Middle Aged; placebos; Probiotic; probiotics; Probiotics - administration & dosage; Probiotics - adverse effects; Probiotics - pharmacokinetics; Safety; Toxicology; yogurt; Yogurt - adverse effects; Yogurt - microbiology; Young Adult; ALT; Cl; K; PRO; N; AlkP; QC; Adverse events; ANOVA; QPS; BSH; Microencapsulation; PO43; Safety; Bile salt hydrolase; BMI; Lactobacillus; Probiotic; AST; AE; CSV; ICH–GCP; LAB; APA; Ca2; GGT; SOP; Na+; Bpm; EC 3.5.1.24; Evaluation; Choloylglycine hydrolase; Enzyme; Toxicity; Tolerance; Randomization; Formulation; Placebo; Secondary effect; Double blind study; Bacteria; Hydrolases; Lactobacillaceae
• ISSN: 0278-6915; 1873-6351; 1873-6351
• DOI: 10.1016/j.fct.2012.03.010

► 120 randomized subjects received microencapsulated Lactobacillus reuteri NCIMB 30242 yogurt or placebo yogurt twice daily for 6weeks. ► No clinically significant differences between groups were detected in blood clinical chemistry or hematology. ► Analysis of fecal samples indicated that there was no significant increase in fecal deconjugated bile acids. ► The frequency and intensity of adverse events was similar in the two groups. 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 6weeks. 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.