Composition and Laboratory Correlation of Commercial Probiotics in India

Abstract

Objectives Probiotics are defined as live microorganisms that, when administered in adequate amounts, confer health benefits to the host. Probiotics are currently being recommended and considered for many medical conditions. The Asia-Pacific region contributes to more than 40% of the global industry. Quality of commercial probiotics remains a challenge globally and has been a major concern in various countries in Europe, South Africa, Taiwan, India, Pakistan, and the USA. Research from these countries indicate that the contents do not correspond to the label information in terms of identity, viability, number of microorganisms or purity. The objective of this study is to assess the commercial probiotic bacterial contents and their label accuracy in India. No previous research has been done in this area in India, on commercial probiotics that are sold as “pharmaceuticals”. Methods A random selection of the most prescribed probiotics for various clinical indications were chosen with a minimum shelf life of 12 months. The probiotics were single and multiple strains and these were evaluated by culture, viable plate count, DNA isolation and targeted metagenomics. Our study is the first step in scrutinizing probiotics in terms of quality and quantity analysis which are used across various age groups for multiple indications. Results Out of the 20 chosen probiotics eight products were single strain and 12 products were multiple strains. These probiotics showed very poor correlation between the declared contents on the pack and lab values in viable cell count colonies, the genus and species strain identification, presence of contaminants and these were confirmed with 16s RNA and next generation sequencing. Conclusion Poor correlation in the quality and quantity of probiotics proves that the label claim and actual claim of these “drugs” show exceptionally poor correlation and raises safety concerns in clinical use, especially in vulnerable age groups such as neonates, children and the elderly. Our study shows that “policing” of these probiotics is essential in protecting these patients who are at risk and ensuring quality control and helping clinicians making the right choice.

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

“…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 ).…”

Spotlight on the Compositional Quality of Probiotic Formulations Marketed Worldwide

“…In culture-dependent analyses, enumeration of different species in multi-species formulations can be critical. To overcome this limit, selective media are commonly used to discriminate species with different metabolic features (Fasoli et al, 2003;Elliot and Teversham, 2004;Aureli et al, 2010;Drago et al, 2010;Toscano et al, 2013;Chen et al, 2014;Di Pierro et al, 2019;Korona-Glowniak et al, 2019;Yonkova Marinova et al, 2019;Kesavelu et al, 2020). Nevertheless, this aim remains challenging, particularly for Lactobacillus and Bifidobacterium species.…”

“…Although some probiotic cells have been shown to maintain their beneficial properties also in a dead form ( Taverniti and Guglielmetti, 2011 ; de Almada et al, 2016 ), probiotics are required to be alive to benefit host health ( FAO/WHO, 2001 ). Considering the limits of culture-dependent and culture-independent techniques, we believe that a combination of both methods should be reasonably applied to definitely decipher the microbial composition of commercial probiotic products, as performed in some of the included studies ( Fasoli et al, 2003 ; Temmerman et al, 2003b ; Masco et al, 2005 ; Angelakis et al, 2011 ; Toscano et al, 2013 ; Lewis et al, 2016 ; Patro et al, 2016 ; Patrone et al, 2016 ; Di Pierro et al, 2019 ; Ullah et al, 2019 ; Kesavelu et al, 2020 ). Recently, whole genome sequence analysis has been proposed as a promising method for the identification of microbes contained in probiotic formulations ( Fusco et al, 2021 ).…”

“…In this study, we also evidenced that the labels of some formulations, particularly functional foods, did not comply general guidelines for probiotic labeling, since not indicating the contained microbes or only reporting a general and inaccurate description (e.g., “LAB,” “probiotics,” “lactic ferment,” “lactic acid bacillus,” “live probiotic AB cultures,” “active bifidus,” “special live cultures,” “viable LAB,” “bifidus essensis,” “life yeast”) ( Fasoli et al, 2003 ; Temmerman et al, 2003a , b ; Elliot and Teversham, 2004 ; Masco et al, 2005 ; Theunissen et al, 2005 ; Lin et al, 2006 ; Perea Vélez et al, 2007 ; Angelakis et al, 2011 ; Chen et al, 2014 ; Kesavelu et al, 2020 ). In addition, we found that some preparations only indicated the contained microbes at the genus level, thus resulting in disagreement with the FAO/WHO guidelines ( Fasoli et al, 2003 ; Temmerman et al, 2003a , b ; Masco et al, 2005 ; Theunissen et al, 2005 ; Lin et al, 2006 ; Perea Vélez et al, 2007 ; Chen et al, 2014 ; Yonkova Marinova et al, 2019 ).…”