Safety Evaluation of a Novel Potentially Probiotic Limosilactobacillus fermentum in Rats.

Abstract

Limosilactobacillus (L) fermentum (strains 139, 263, 296) is a novel probiotic mixture isolated from fruit processing by-products. The use of this formulation has been associated with improvements in cardiometabolic, inflammatory, and oxidative stress parameters. The present study evaluated the safety of a potential multi-strain probiotic by genotoxicity (micronucleus assay) and subchronic toxicity study (13-week repeated dose). In the genotoxicity evaluation, L. fermentum 139, 263, 296 did not increase the frequency of micronuclei in erythrocytes of rats of both sexes at doses up to 1010CFU/mL. In the subchronic toxicity study, the administration of L. fermentum did not promote adverse health effects, such as behavioral changes, appearance of tumors, changes in hematological and biochemical parameters. In addition, higher doses of L. fermentum 139, 263, 296 have been shown to reduce the levels of pro-inflammatory cytokines. Administration of potentially probiotic L. fermentum did not promote adverse health effects in rats and could be evaluated as a potential probiotic for humans.