http://sgpwe.izt.uam.mx/files/users/uami/acym/articulo_1.pdf

Food fermentations: Microorganisms with technological beneficial use

The safety of probiotics is tied to their intended use, which includes consideration of potential vulnerability of the consumer or patient, dose and duration of consumption, and both the manner and frequency of administration. Unique to probiotics is that they are alive when administered, and unlike other food or drug ingredients, possess the potential for infectivity or in situ toxin production. Since numerous types of microbes are used as probiotics, safety is also intricately tied to the nature of the specific microbe being used. The presence of transferable antibiotic resistance genes, which comprises a theoretical risk of transfer to a less innocuous member of the gut microbial community, must also be considered. Genetic stability of the probiotic over time, deleterious metabolic activities, and the potential for pathogenicity or toxicogenicity must be assessed depending on the characteristics of the genus and species of the microbe being used. Immunological effects must be considered, especially in ...

https://www.tandfonline.com/doi/pdf/10.4161/gmic.1.3.12127

Safety assessment of probiotics for human use

OBJECTIVE: Systematic reviews of randomized, controlled trials (RCTs) indicate lower mortality and necrotizing enterocolitis (NEC) and shorter time to full feeds after probiotic supplementation in preterm ( METHODS: We searched in March 2009 the Cochrane Central register; Medline, Embase, and Cinahl databases; and proceedings of the Pediatric Academic Society meetings and gastroenterology conferences. Cochrane Neonatal Review Group search strategy was followed. Selection criteria were RCTs of any enteral probiotic supplementation that started within first 10 days and continued for ≥7 days in preterm VLBW neonates and reported on stage 2 NEC or higher (Modified Bell Staging). RESULTS: A total of 11 (N = 2176), including 4 new (n = 783), trials were eligible for inclusion in the meta-analysis by using a fixed-effects model. The risk for NEC and death was significantly lower. Risk for sepsis did not differ significantly. No significant adverse effects were reported. Trial sequential analysis) showed 30% reduction in the incidence of NEC (α = .05 and .01; power: 80%). CONCLUSIONS: The results confirm the significant benefits of probiotic supplements in reducing death and disease in preterm neonates. The dramatic effect sizes, tight confidence intervals, extremely low P values, and overall evidence indicate that additional placebo-controlled trials are unnecessary if a suitable probiotic product is available.

Updated Meta-analysis of Probiotics for Preventing Necrotizing Enterocolitis in Preterm Neonates

[Table: see text]. Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the characterisation of microorganisms used as feed additives or as production organisms.

https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2018.5206

Guidance on the characterisation of microorganisms used as feed additives or as production organisms

Monitoring of verotoxigenic Escherichia coli (VTEC) and identification of human pathogenic VTEC types 1 Scientific Opinion of the Panel on Biological Hazards

Results: Tentative ECOFF values of 13 antibiotics were determined for up to 12 LAB species. Generally, LAB were susceptible to penicillin, ampicillin, ampicillin/sulbactam, quinupristin/dalfopristin, chloramphenicol and linezolid. LAB exhibited broad or partly species-dependent MIC profiles of trimethoprim, trimethoprim/sulfamethoxazole, vancomycin, teicoplanin and fusidic acid. Three probiotic Lactobacillus strains were highly resistant to streptomycin. Although erythromycin, clindamycin and oxytetracycline possessed high antimicrobial activities, 17 Lactobacillus isolates were resistant to one or more of these antibiotics. Eight of them, including six probiotic and nutritional cultures, possessed erm(B) and/or tet(W), tet(M) or unidentified members of the tet(M) group. In vitro intra- and interspecies filter-mating experiments failed to show transfer of resistance determinants.

/pdf/antimicrobial-susceptibilities-of-lactobacillus-pediococcus-5e8gov4yhc.pdf

Antimicrobial susceptibilities of Lactobacillus, Pediococcus and Lactococcus human isolates and cultures intended for probiotic or nutritional use

On June 26–27, 2006, 60 academic and industry scientists gathered during the PROSAFE workshop to discuss recommendations on taxonomy, antibiotic resistance, in vitro assessment of virulence and in vivo assessment of safety of probiotics used for human consumption. For identification of lactic acid bacteria (LAB) intended for probiotic use, it was recommended that conventional biochemical methods should be complemented with molecular methods and that these should be performed by an expert lab. Using the newly developed LAB Susceptibility test Medium (LSM), tentative epidemiological cut-off values were proposed. It was recommended that potentially probiotic strains not belonging to the wild-type distributions of relevant antimicrobials should not be developed as future products for human or animal consumption. Furthermore, it was recommended that the use of strains harbouring known and confirmed virulence genes should be avoided. Finally, for in vivo assessment of safety by investigating strain pathogenicity in animal models, the rat endocarditis model appeared to be the most reliable model tested in the PROSAFE project. Moreover, consensus was reached for approving the necessity of a human colonisation study in a randomised placebo-controlled double-blind design; however, further discussions are needed on the details of such as study.

Vanessa Vankerckhoven

Papers

Antimicrobial susceptibilities of Lactobacillus, Pediococcus and Lactococcus human isolates and cultures intended for probiotic or nutritional use

Biosafety assessment of probiotics used for human consumption: recommendations from the EU-PROSAFE project