Abstract

In the last decade, many authors have reported low viability for probiotic products. Investigators commonly find they are not meeting claimed active counts and/or incorrect species and/or strains have been identified. We have therefore decided to verify viability, the real dose and species correspondence in nine probiotic products (seven nutritional supplements and two medical devices) collected from the Italian and French markets claiming to contain at least one strain of L. crispatus among the different species/strain included in the formulation. In fact, the medical relevance of L. crispatus strains has recently grown., as evaluating the possible dominance clusters typical of the vaginal microbiota, the Community State Type I, the one dominated by L. crispatus, appears to be “protective” in terms of infections, fertility and gestational duration of pregnancy. The results obtained demonstrate the generally poor quality of probiotics. Out of nine products, only two definitely contained viable Lactobacillus crispatus cells with a daily dose of at least 1 × 109 CFU/g and with an acceptable correspondence with what is declared on the label. Among these two, only one was found to be formulated with a strain (M247) that has been scientifically documented.

Highlights

  • Probiotics, defined by a consensus panel of experts in 2014 as “live microorganisms that when administered in adequate amounts confer a health benefit on the host”, are considered to be endowed with properties capable of enhancing health and reducing the risk of disease [1]

  • MRS agar (DeMan Rogosa Sharpe, BD, Difco, Milan, Italy) was used for the total viable count, MRS agar supplemented with 0.1 and 10 μg/mL clindamycin and ciprofloxacin was used for the enumeration of L. crispatus and L. gasseri, and MRS agar supplemented with 10 μg/mL vancomycin was used for the selection of L. rhamnosus and L. reuteri [17]

  • All products were counted on MRS agar to determine the total viable count of lactobacilli, on MRS agar supplemented with 0.1 and 10 μg/mL clindamycin and ciprofloxacin for the selection of L. crispatus and L. gasseri species (ISO 20128:2006) and MRS agar supplemented with 10 μg/mL of vancomycin for the isolation of L. rhamnosus and L. reuteri (ISTISAN 2008/36: 35–63)

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Summary

Introduction

Probiotics, defined by a consensus panel of experts in 2014 as “live microorganisms that when administered in adequate amounts confer a health benefit on the host”, are considered to be endowed with properties capable of enhancing health and reducing the risk of disease [1]. The public’s growing interest in probiotics as a tool to enhance quality of life has strongly prompted the probiotics market to expand, and analysis forecasts confirm increasing sales [3]. For all these reasons, new probiotic strains are being continuously selected and formulated in finished forms by the dairy and pharma industries. Low-quality profiles reduce both professional and consumer confidence in probiotics and instill the idea that anyone, even those with low-grade competence, can develop, manufacture, promote and sell probiotics This situation, if not properly addressed, will likely determine in the future a decrease in probiotic use and sales. This threat is so real that it has prompted the International

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