DeVette Christa I, Sugino Kameron, Wilson Adam, Fuller Kevin, Friedman Jacob E, Burge Kathryn Y, Chaaban Hala
Department of Pediatrics, The University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
Oklahoma Children's Hospital, Oklahoma City, OK, USA.
Pediatr Res. 2025 Jan 24. doi: 10.1038/s41390-025-03831-6.
To evaluate the label accuracy of commercial infant probiotic products and identify potential microbial contamination.
DNA was extracted from seventeen infant probiotic products purchased from a large online vendor. Samples underwent 16S ribosomal RNA gene sequencing, QIIME analysis, and bacterial taxonomic classification. Identified bacterial species were compared with product labels for label accuracy and potential contaminants. Additionally, fungal DNA was amplified using qPCR with universal 18S fungal primers, and cultures were performed to assess viability.
Over 82% of bacterial DNA extracted from samples corresponded to species listed on product labels. Contaminating bacteria were closely related species. Lot-to-lot variation in bacterial species abundance was greater in multi-strain products compared with single-strain products. Fungal DNA was detected in some samples, but culture results indicated these organisms were not viable.
This pilot study highlights that most bacterial species in commercial infant probiotic products are accurately represented on labels. Single-strain products reliably match product labels whereas multi-strain products were more prone to variation of species abundance and species omission. Additionally, fungal contamination of limited samples was not viable. These findings emphasize the need for improved regulatory guidelines and standardization of probiotic products, particularly those marketed for infants.
Commercial infant probiotic products were interrogated for label accuracy using 16S ribosomal RNA sequencing. Most bacterial species in commercial infant probiotic products are accurately represented on labels without pathogenic bacterial contamination. Live fungal contamination is absent. To date, no studies have interrogated infant probiotic products on this scale (other studies have been limited to single or dual strain infant probiotics). Since probiotics lack FDA regulation, this pilot study provides important information for pediatricians and consumers, further highlighting the need for improved quality control and standardization of probiotics.
评估市售婴儿益生菌产品的标签准确性，并识别潜在的微生物污染。
从一家大型在线供应商购买的17种婴儿益生菌产品中提取DNA。样本进行16S核糖体RNA基因测序、QIIME分析和细菌分类学分类。将鉴定出的细菌物种与产品标签进行比较，以评估标签准确性和潜在污染物。此外，使用通用18S真菌引物通过qPCR扩增真菌DNA，并进行培养以评估活力。
从样本中提取的超过82%的细菌DNA与产品标签上列出的物种相对应。污染细菌是密切相关的物种。与单菌株产品相比，多菌株产品中细菌物种丰度的批次间差异更大。在一些样本中检测到真菌DNA，但培养结果表明这些微生物没有活力。
这项初步研究强调，市售婴儿益生菌产品中的大多数细菌物种在标签上有准确的表述。单菌株产品与产品标签可靠匹配，而多菌株产品更容易出现物种丰度变化和物种遗漏。此外，有限样本中的真菌污染没有活力。这些发现强调了改进益生菌产品监管指南和标准化的必要性，特别是针对面向婴儿销售的产品。
使用16S核糖体RNA测序对市售婴儿益生菌产品的标签准确性进行了调查。市售婴儿益生菌产品中的大多数细菌物种在标签上有准确表述，无致病细菌污染。不存在活真菌污染。迄今为止，尚无研究在如此规模上对婴儿益生菌产品进行调查（其他研究仅限于单菌株或双菌株婴儿益生菌）。由于益生菌缺乏FDA监管，这项初步研究为儿科医生和消费者提供了重要信息，进一步凸显了改进益生菌质量控制和标准化的必要性。
