Commercial Probiotic Products

Abstract

Probiotics have been proposed for a number of indications ranging from the hypothetical long-term immunomodulatory effects to proven benefits in the management of different clinical conditions.An increasing number of commercial products containing probiotics are available. In those products, irrespective if it is food, food supplement, medical food, or drug, the probiotic microorganisms have to be present in a sufficient number by the end of the shelf-life, to pass through the gastrointestinal tract resisting acid and bile, to colonize the gut, and to retain functional properties required to obtain the suggested beneficial effect. Finally, it should be contamination-free.Studies organized worldwide and summarized in this article have shown that inconsistencies and deviations from the information provided on the product label are surprisingly common. Frequently strains are misidentified and misclassified, products are occasionally contaminated, sometimes with even facultative or obligatory pathogens, strains are not viable, the labeled number of colonies cannot be verified, or the functional properties are diminished to the extent that preclude the proposed health benefit. As the probiotic preparations are commonly used for a wide range of conditions, the aim of the Working Group was to summarize results of the studies looking into the quality of the probiotic products and to raise the awareness of the important issue of their quality control.Based on the results obtained, we strongly suggest a more stringent quality control process. This process should ensure that the probiotic content as mentioned on the label meets the actual content throughout the shelf life of the product, while no contamination is present.

Reviewing the Composition of Vaginal Microbiota: Inclusion of Nutrition and Probiotic Factors in the Maintenance of Eubiosis

“…Indeed, if probiotics are prescribed in the treatment with specific disorders, they should be regulated as drugs rather than foods or supplements. Under this formula, adverse consequences connected to the use of probiotics should be shared and registered by health authorities [220]. Nowadays, probiotic effects seem to be strain specific and dose dependent, and the lack of standardized manufacturing procedures affect multiple factors such as microbial survival, their growth, and their viability [220].…”

“…Under this formula, adverse consequences connected to the use of probiotics should be shared and registered by health authorities [220]. Nowadays, probiotic effects seem to be strain specific and dose dependent, and the lack of standardized manufacturing procedures affect multiple factors such as microbial survival, their growth, and their viability [220]. At the research level, active work in the field is needed and well-designed studies in the future should also focus on other aspects such as: (i) the efficacy and search of distinct mixtures of strains of probiotic species in the restoration of vaginal microbiota, (ii) a consensus in the duration of the treatment with probiotics and colony-forming units employed for restoration in launched studies, and (iii) a better understanding of the combination of antibiotics and probiotics when both are provided together [39].…”

How to Assess in vitro Probiotic Viability and the Correct Use of Neutralizing Agents

“…Two more terms are useful to understand this opinion: "microbiota, " which is a collective term for the microorganisms that live in or on the human body (specific clusters of microbiota are found on the skin or in the gastrointestinal tract, mouth, vagina, and eyes) and "microbiome, " which comprises all the genetic material within a microbiota (the entire collection of microorganisms in a specific niche, such as the human gut) and which can also be referred to as the metagenome of the microbiota (Rothschild et al, 2018). After the first attempts made by FAO andWHO (Food andAgriculture Organization of the United Nations, 2002, 2006) to provide health and nutritional information and guidelines to evaluate probiotics, in view of the growing popularity of probiotic foods and the lack of international consensus on the methodology to assess their efficacy and safety, several societies and associations have more recently released a number of guidelines or position papers on this topic (Hill et al, 2014;Kolacek et al, 2017). Despite many attempts made by regulatory bodies (Kolacek et al, 2017), the status of probiotic products has not been established on an international basis-there is no label control and there are no periodic screenings of the products' quality and safety.…”

“…After the first attempts made by FAO andWHO (Food andAgriculture Organization of the United Nations, 2002, 2006) to provide health and nutritional information and guidelines to evaluate probiotics, in view of the growing popularity of probiotic foods and the lack of international consensus on the methodology to assess their efficacy and safety, several societies and associations have more recently released a number of guidelines or position papers on this topic (Hill et al, 2014;Kolacek et al, 2017). Despite many attempts made by regulatory bodies (Kolacek et al, 2017), the status of probiotic products has not been established on an international basis-there is no label control and there are no periodic screenings of the products' quality and safety. Apart from the issues related to hygiene and safety and to the taxonomy, nomenclature, and classification of strains (Aureli et al, 2010;Lefevre et al, 2015;Llewellyn and Foey, 2017;Suez et al, 2018;Zmora et al, 2018), research mainly focuses on the viability and survival of commercial probiotic formulations during their passage through the gastro-intestinal (GI) tract (Drago et al, 2004;Cook et al, 2011;Dominici et al, 2011;Sahadeva et al, 2011;Jensen et al, 2012;Fredua-Agyeman and Gaisford, 2014;Vecchione et al, 2018).…”

“…However, whatever the consensus is on colonization, acid and bile resistance are characteristics used to select potential probiotic strains. In fact, although probiotic formulations have to contain a sufficient number of living microorganisms (Kolacek et al, 2017), it is of the utmost importance for the release of bacteria from the formulation to be controlled and their deposition to be spread along the intestine in order to deliver probiotics to both small and large intestine. To this end, many in vitro studies have been conducted, and the results show heterogeneous behavior, depending on the species or strains analyzed and methods applied (Chandramouli et al, 2004;Lin et al, 2006;Cook et al, 2011;Sahadeva et al, 2011;Jensen et al, 2012;Fredua-Agyeman and Gaisford, 2014;Li et al, 2019).…”