Abstract

Bacterial vaginosis and vulvovaginal candidiasis are common causes of impaired health and quality of life for women. Although antimicrobial agents remain the main strategy for the treatment of vaginal infections, their repeated use involves high rates of resistance and recurrence. Alternative approaches such as probiotics are studied. Saccharomyces cerevisiae CNCM I-3856 already demonstrated beneficial effects in experimental models of vaginal infections. This randomized, double-blind, placebo-controlled clinical study was performed to evaluate the recovery of S. cerevisiae CNCM I-3856 in vaginal samples in healthy women after oral consumption. Sixty healthy women were randomized to receive a daily dose of S. cerevisiae CNCM I-3856 or a placebo for 4 weeks. Subcultures and quantitative polymerase chain reaction (qPCR) were used to detect the strain in vaginal and stool samples. A safety assessment was carried out throughout the study. Fifty-seven women completed the study. Over the 4-week supplementation phase, S. cerevisiae CNCM I-3856 has been detected in the vaginal samples of 21% of women (n = 4/19) in the 500 mg Probiotic group and 16% of women (n = 3/19) in the 1000 mg Probiotic group. The strain was detected in the faeces of 90% of women consuming the probiotic. This is the first clinical study demonstrating the migration of yeast from intestine to vagina where it may exert its benefits.

Highlights

  • The vaginal microbiota is a dynamic microbial community subjected to internal and external factors such as hormones variations occurring in women’s life, phases of the menstrual cycle, drug treatments such as antibiotics and contraceptives, concomitant pathologies and life habits [1,2,3]

  • Over the 4-week supplementation phase, S. cerevisiae CNCM I-3856 has been detected in the vaginal samples of 21% of women (n = 4/19) in the 500 mg Probiotic group and 16% of women

  • Considering that the ability of a probiotic to migrate from intestinal to vaginal sphere is probably multifactorial and associated with the strain properties, the implementation of a new protocol would be the opportunity to study the influence of inter-individual morphology and genetic background, intrinsic factors such as age, smoking, ethnic groups and environmental factors on the vaginal microbiota composition [53] and the migration of a probiotic after oral administration. This exploratory clinical study demonstrates the recovery of S. cerevisiae CNCM I-3856 in vaginal samples after oral administration

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Summary

Introduction

The vaginal microbiota is a dynamic microbial community subjected to internal and external factors such as hormones variations occurring in women’s life, phases of the menstrual cycle, drug treatments such as antibiotics and contraceptives, concomitant pathologies and life habits [1,2,3]. These factors can influence the fragile balance of the vaginal ecosystem, creating a favorable environment to the development of opportunistic pathogens. These infections may cause severe complications of the upper genital tract (e.g., endometritis, salpingitis and pelvic inflammatory disease) leading to tubal scarring, infertility or ectopic pregnancies [8,9]

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