Clinical safety and toxicology of Cardioviva™ capsules

Evaluation of clinical safety and tolerance of a Lactobacillus reuteri NCIMB 30242 supplement capsule

Mitchell L. Jones, Christopher J. Martoni, Erminia Di Pietro, Ryan R. Simon, and Satya Prakash

A significant number of human clinical trials have reported no adverse effects associated with consumption of Lactobacillus reuteri (L. reuteri). In the present study, the clinical safety and toxicology of oral ingestion of supplement capsules containing L. reuteri NCIMB 30242 was investigated. A randomized group of 131 subjects received a dose of 2.9 x 109 CFU L. reuteri NCIMB 30242 capsules (n = 67) or placebo capsules (n = 64) twice daily for 9 weeks. Clinical chemistry and hematological parameters of safety were analyzed. The frequency, duration and intensity of adverse events (AE)s and clinical significance of safety parameters were recorded for both groups. No clinically significant differences between the probiotic capsule and placebo capsule treated groups were detected in either the blood clinical chemistry or hematology results. The frequency and intensity of AEs was similar in the two groups. These results demonstrate that administration of a twice daily dose of 2.9 x 109 CFU was safe and well tolerated in the population evaluated over 9 weeks.

Regul Toxicol Pharmacol. 2012 Apr 25. [Epub ahead of print]

Results: L. reuteri NCIMB 30242 capsules altered LDL-C by 11.64% (P<0.001), total cholesterol by 9.14%, (P<0.001), non-HDL-cholesterol (non-HDL-C) by 11.30% (P<0.001) and apoB-100 by 8.41% (P=0.002) relative to placebo. The ratios of LDL-C/HDL-cholesterol (HDL-C) and apoB-100/apoA-1 were altered by 13.39% (P=0.006) and 9.00% (P=0.026), respectively, relative to placebo. Triglycerides and HDL-C were unchanged. High-sensitivity C-reactive protein and fibrinogen were altered by 1.05?mg/l (P=0.005) and 14.25% (P=0.004) relative to placebo, respectively. Mean plasma deconjugated bile acids were increased by 1.00?nmol/l (P=0.025) relative to placebo, whereas plasma campesterol, sitosterol and stigmasterol were decreased by 41.5%, 34.2% and 40.7%, respectively.

Conclusions: The present results suggest that the deconjugation of intraluminal bile acids results in altered absorption of non-cholesterol sterols and indicate that L. reuteri NCIMB 30242 capsules may be useful as an adjunctive therapy for treating hypercholesterolemia.

European Journal of Clinical Nutrition , (19 September 2012) | doi:10.1038/ejcn.2012.


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