Safety Assessment of Lactobacillus fermentum CECT5716, a probiotic strain isolated from human milk

2009-03-13
Journal of Dairy Research 76(2)
- F. Lara‐Villoslada
- S. Sierra
- M. Díaz-Ropero
- J. M. Rodríguez
- J. Xaus
- M. Olivares

PubMed: 19281631
DOI: 10.1017/S0022029909004014

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 40
Population: Balb/C mice
Methods: Controlled experimental study

Animal Study

Abstract

Lactobacillus fermentum CECT5716, a probiotic strain isolated from human milk, was characterized in a previous study. The objective of this study was to evaluate its sensitivity to antibiotics and its potential toxicity and translocation ability after oral administration to mice. For this purpose, 40 Balb/C mice were divided in two groups (n=20 per group). One group was treated orally with 10(10) colony forming units (cfu)/mouse/day of Lb. fermentum CECT5716 during 28 d. The other group only received the excipient and was used as control. Food intake, body weight, bacterial translocation and different biochemical and haematological parameters were analysed. Oral administration of Lb. fermentum CECT5716 to mice had no adverse effects on mice. There were no significant differences in body weight or food intake between control and probiotic-treated mice. No bacteraemia was observed and there was no treatment-associated bacterial translocation to liver or spleen. Stress oxidative markers were not different in control and probiotic-treated mice. These results suggest that the strain Lb. fermentum CECT5716 is non-pathogenic for mice even in doses 10,000 times higher (expressed per kg of body weight) than those normally consumed by humans.

Research Insights

Lactobacillus fermentum MAK20L13F→Absence of Bacterial Translocation to Liver or Spleen
No bacteraemia was observed and there was no treatment-associated bacterial translocation to liver or spleen.
Effect
Neutral
Effect size
Large
Lactobacillus fermentum MAK20L13F→No Change in Oxidative Stress Markers
Stress oxidative markers were not different in control and probiotic-treated mice.
Effect
Neutral
Effect size
Large
Lactobacillus fermentum MAK20L13F→No Significant Weight Change
There were no significant differences in body weight or food intake between control and probiotic-treated mice.
Effect
Neutral
Effect size
Large
Lactobacillus fermentum UALf-32→Absence of Bacteremia
No bacteraemia was observed and there was no treatment-associated bacterial translocation to liver or spleen.
Effect
Neutral
Effect size
Moderate
Lactobacillus fermentum UALf-32→No Adverse Health Effects
Oral administration of Lb. fermentum CECT5716 to mice had no adverse effects on mice.
Effect
Neutral
Effect size
Large
Lactobacillus fermentum UALf-32→No Change in Oxidative Stress Markers
Stress oxidative markers were not different in control and probiotic-treated mice.
Effect
Neutral
Effect size
Large
Lactobacillus fermentum UALf-32→No Significant Weight Change
There were no significant differences in body weight or food intake between control and probiotic-treated mice.
Effect
Neutral
Effect size
Large
Lactobacillus fermentum UALf-32→Nonpathogenic Even at High Doses
These results suggest that the strain Lb. fermentum CECT5716 is non-pathogenic for mice even in doses 10,000 times higher (expressed per kg of body weight) than those normally consumed by humans.
Effect
Neutral
Effect size
Moderate
Lactobacillus fermentum VPro 14→No Adverse Health Effects
Oral administration of Lb. fermentum CECT5716 to mice had no adverse effects on mice.
Effect
Neutral
Effect size
Large