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.

Keywords: 16srna; cell count; commercial; india; ngs; paediatrics; probiotics; quality; safety; targeted metagenomics.