Safety assessment is an essential phase in the development of any new food. Although few pro-biotic strains or prebiotic compounds have been specifically tested for safety, the long history of safe consumption of some probiotic strains could be considered the best proof of their safety. Although some lactobacilli and bifidobacteria have been associated with rare cases of bacteremia, usually in patients with severe underlying diseases, the safety of members of these genera is generally recognized due to their long history of safe use and their lack of toxicity. Furthermore, the low incidence of infections attributable to these microorganisms, together with a recent study showing that there is no increase in the incidence of bacteremia due to lactobacilli in Finland despite the increased consumption of probiotic lactobacilli, supports this hypothesis. With regard to other bacteria such as enterococci, S. boulardii, Clostridium butyricum, or some members of the genus Bacillus the situation is more complicated, even though they have been used as probiotics for some time.

In addition to the possibility of infection there are other risks that must be taken into account (Table 1). These include those risks associated with the metabolic properties of the strain (capacity for deconjugation/dehydroxylation of bile salts,

Table 1 Probiotic action: potential benefits and risks

Action mechanisms

Potential risks

Improvement of gut barrier

Proinflammatory effects

(immunologic, nonimmunologic)

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