The aim of this study was to evaluate in the vagina of 60 pre-menopausal women the detection of orally administered multispecies probiotic formulations showing anti-microbial properties in test in vitro.
A randomized, double-blind, three-arm parallel pilot study was carried out on 60 pre-menopausal women. Subjects were randomly divided in three groups (F_1, F_2, F_3). Each group received a daily oral administration of probiotic mixtures (for 14 days and at the day 21, 7 days after the wash-out) containing: Lactobacillus acidophilus and Lactobacillus reuteri (F_1), or Lactobacillus plantarum, Lactobacillus rhamnosus and Bifidobacterium animalis subsp. lactis (F_2), or placebo (F_3), respectively. Vaginal swabs were collected at four experimental times, at t0 and at t7, t14 and t21 days, and analyzed by qPCR. At the same time, the anti-microbial activity of the probiotic formulations was verified by assays in vitro against microorganisms as Escherichia coli and Candida albicans.
L. acidophilus and L. reuteri as well as L. plantarum, L. rhamnosus and B. lactis were significantly increased on 7 days in the groups administered with F_1 and F_2, respectively, compared to group F_3. A similar significant trend was observed on 21 days, 7 days after the wash-out. F_1 and F_2 showed coherent anti-microbial properties.
Both probiotic formulations F_1 and F_2, chosen because of their anti-microbial activity against pathogens responsible for vaginal dysbiosis and infections, led to vaginal detection and enhancement of the amount of species of formulates when orally administered. This work provides the basis for further clinical investigations of the F_1 and F_2 capacity to prevent or treat uro-genital infections.
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The research was conducted through the Probioplus4Food Project, funded by MIUR and Lombardy Region, Italy. We thank Principium Europe Srl for supplying the bacterial strains and oral probiotic capsules. We thank Dr. Anna Sandionigi for supporting the statistical analyses.
Conflict of interest
The authors declare that there is no conflict of interest regarding the publication of this paper.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
An erratum to this article is available at http://dx.doi.org/10.1007/s00404-016-4280-x.
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Mezzasalma, V., Manfrini, E., Ferri, E. et al. Orally administered multispecies probiotic formulations to prevent uro-genital infections: a randomized placebo-controlled pilot study. Arch Gynecol Obstet 295, 163–172 (2017). https://doi.org/10.1007/s00404-016-4235-2