Safety assessment of probiotics for human 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 certain vulnerable populations, including infants with undeveloped immune function. A few reports about negative probiotic effects have surfaced, the significance of which would be better understood with more complete understanding of the mechanisms of probiotic interaction with the host and colonizing microbes. Use of readily available and low cost genomic sequencing technologies to assure the absence of genes of concern is advisable for candidate probiotic strains. The field of probiotic safety is characterized by the scarcity of studies specifically designed to assess safety contrasted with the long history of safe use of many of these microbes in foods

Neonatal hyperbilirubinemia in African American males : the importance of glucose-6-phosphate dehydrogenase deficiency

Objective: To perform risk factor analysis for the prediction of hyperbilirubinemia in an African American male neonatal cohort. Study design: A database of 500 previously published term and near-term African American male neonates was further analyzed to determine the role of risk factors for hyperbilirubinemia. Factors studied included birth weight ≥4.0 kg, gestational age ≤37 weeks, breast-feeding, glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, and predischarge bilirubin ≥75th percentile. Hyperbilirubinemia was defined as any bilirubin value ≥95th percentile on the hour-of-life–specific bilirubin nomogram. Results: Forty-three (8.6%) neonates developed hyperbilirubinemia. At 48 ± 12 hours, median transcutaneous bilirubin was 8.3 mg/dL, 75th percentile 10.0 mg/dL, and 95th percentile 12.6 mg/dL. Of the risk factors, only exclusive breast-feeding, G-6-PD deficiency and predischarge bilirubin ≥75th percentile were significant (Adjusted Odds Ratios [95% Confidence Intervals; CI] 3.15 [1.39-7.14], P = .006; 4.96 [2.28-10.80], P = .001; and 7.47 [3.50-15.94], P < .0001, respectively). G-6-PD–deficient neonates who were also premature and breast-feeding had the highest incidence of hyperbilirubinemia (60%). Conclusions: African American male neonates may be at higher risk for hyperbilirubinemia than previously thought. Screening for G-6-PD deficiency and predischarge bilirubin determination may be useful adjuncts in hyperbilirubinemia prediction in these newborns.6 page(s