Do Your Kids Get What You Paid for? Evaluation of Commercially Available Probiotic Products Intended for Children in the Republic of the Philippines and the Republic of Korea

Abstract

A wide range of probiotic products is available on the market and can be easily purchased over the counter and unlike pharmaceutical drugs, their commercial distribution is not strictly regulated. In this study, ten probiotic preparations commercially available for children’s consumption in the Republic of the Philippines (PH) and the Republic of Korea (SK) have been investigated. The analyses included determination of viable counts and taxonomic identification of the bacterial species present in each formulation. The status of each product was assessed by comparing the results with information and claims provided on the label. In addition to their molecular identification, safety assessment of the isolated strains was conducted by testing for hemolysis, biogenic amine production and antibiotic resistance. One out of the ten products contained lower viable numbers of recovered microorganisms than claimed on the label. Enterococcus strains, although not mentioned on the label, were isolated from four products. Some of these isolates produced biogenic amines and were resistant to one or several antibiotics. Metagenomic analyses of two products revealed that one product did not contain most of the microorganisms declared in its specification. The study demonstrated that some commercial probiotic products for children did not match their label claims. Infants and young children belong to the most vulnerable members of society, and food supplements including probiotics destined for this consumer group require careful checking and strict regulation before commercial distribution.

Evaluation of Dietary Supplements Containing Viable Bacteria by Cultivation/MALDI-TOF Mass Spectrometry and PCR Identification

“…In addition, advanced formulations or strain characteristics often require optimised protocols, and protocols developed by manufacturers are often not available. Nevertheless, several recent studies conducted in different parts of the world, such as China, United States–Canada, Philippines–Korea, Italy–France, and Poland, have demonstrated through plate counting that products that do not comply with labels are still regularly found in the market ( Chen et al, 2017 ; Di Pierro et al, 2019 ; Korona-Glowniak et al, 2019 ; Dioso et al, 2020 ; Shehata and Newmaster, 2020 ). Chen et al (2017) reported that viable cells could not be recovered from two (25%) probiotic supplements from the Chinese market.…”

“…Five out of 10 (50%) tested products available in Poland did not reach the number of viable bacteria claimed by the manufacturer ( Korona-Glowniak et al, 2019 ). One in 10 (10%) probiotic preparations available for consumption by children in the Republic of the Philippines and the Republic of Korea contained a lower number of viable microorganisms than claimed on the label ( Dioso et al, 2020 ). The number of viable microorganisms determined in 72 samples of probiotic products from the United States and Canada was lower than labelled in 5 samples (6.9%), including one product that had no viable cells ( Shehata and Newmaster, 2020 ).…”

“…2016; Chen et al, 2017;Ansari et al, 2019;Di Pierro et al, 2019;Korona-Glowniak et al, 2019;Seol et al, 2019;Aldawsari et al, 2020;Dioso et al, 2020;Kesavelu et al, 2020;Shehata and Newmaster, 2020;Vermeulen et al, 2020).…”

“…The need for stricter control of orally administered probiotic formulations, which should contain the specified number of viable bacteria and be free of contaminating microorganisms, was also recently highlighted by the European Society for Paediatric Gastroenterology Hepatology and Nutrition Working Group for Probiotics and Prebiotics ( Kolacek et al, 2017 ). Although significant improvements in the quality of these products have been observed in other markets in recent years, deficiencies in the content and viability of the declared microorganisms are still regularly reported ( Lewis et al, 2016 ; Chen et al, 2017 ; Ansari et al, 2019 ; Di Pierro et al, 2019 ; Korona-Glowniak et al, 2019 ; Seol et al, 2019 ; Aldawsari et al, 2020 ; Dioso et al, 2020 ; Kesavelu et al, 2020 ; Shehata and Newmaster, 2020 ; Vermeulen et al, 2020 ).…”

“…Products containing multiple strains present a particular challenge, as not all strains need to be present in the same quantity at the time of production and can vary greatly in viability during storage. In addition to conventional cultivation-based and PCR-based methods for viability assessment and identification, more advanced methods are increasingly being used, such as next-generation sequencing, terminal restriction fragment length polymorphism, and matrix-assisted laser desorption ionisation time-of-flight mass spectrometry (MALDI-TOF MS) ( Angelakis et al, 2011 ; Lewis et al, 2016 ; Morovic et al, 2016 ; Patro et al, 2016 ; Čanžek Majhenič et al, 2018 ; Huang and Huang, 2018 ; Vecchione et al, 2018 ; Celandroni et al, 2019 ; Seol et al, 2019 ; Dioso et al, 2020 ; Vermeulen et al, 2020 ). Although some of them, such as viability PCR methods and advanced flow cytometry methods, are rapid and provide high-quality results, they may not be as useful for routine quality control because they require expensive equipment and chemicals as well as well-trained personnel.…”