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. 2025 Feb 28;13(3):547.
doi: 10.3390/microorganisms13030547.

Refining Unfavorable Vaginal Microbial Community in Infertile Women Subjected to Precision Probiotic Intervention: An Exploratory Single-Arm, Prospective, Open-Label, Interventional Study

Giovanna Cocomazzi  1 , Viviana Contu  2 , Silvia De Stefani  3 , Lino Del Pup  4 , Matteo Buccheri  5 , Monica Antinori  6 , Lodovico Parmegiani  7 , Daniele De Ruvo  8 , Francesco Marino  9 , Edy Virgili  10 , Christine Allen  11 , Simone Palini  12 , Walter Ciampaglia  7 , Matteo Cerboneschi  13 , Domenico Baldini  14 , Giorgio Maria Baldini  14 , Valerio Pazienza  1
Affiliations

Refining Unfavorable Vaginal Microbial Community in Infertile Women Subjected to Precision Probiotic Intervention: An Exploratory Single-Arm, Prospective, Open-Label, Interventional Study

Giovanna Cocomazzi et al. Microorganisms. .

Abstract

Background and aims: Vaginal microbiomes have been classified into five different general categories, termed Community State Type (CSTs), with CST-III and CST-IV often associated with vaginal dysbiosis which makes women more prone to recurrent infections and assisted reproductive technology (ART) failure. Since a healthy microbiome is one of the key steps for successful reproduction, we investigated the impact of modulating the vaginal microbiota through the oral administration of probiotic formula consisting of a consortium of vaginal-specific lactobacilli and prebiotics (Personal Flora 2®).

Methods: We recruited 32 women who had previous failed IVF cycles and were scheduled to undergo ART. We examined the composition of the vaginal microbiota before and after oral probiotic supplementation using 16S ribosomal RNA (rRNA) sequencing technology.

Results: Our data show a noticeable modulation of the vaginal microbiome upon probiotic supplementation. In particular, precision probiotic intervention lowers the species diversity, favoring the dominance of Lactobacillus (p = 0.015) and Bifidobacterium (p = 0.000) whilst decreasing the percentage of Atopobium (p = 0.003), Gardnerella (p = 0.022), and Prevotella (p = 0.000).

Conclusions: Although CST-III and CST-IV are generally considered detrimental, gynecologists should not refrain from performing IVF in these women if they have been previously subjected to a consortium of precision probiotics treatments, as the administration of specific probiotics reduces the presence of pathogenic bacteria promoting the increase in lactobacilli associated with a healthy vaginal ecosystem, which could impact pregnancy success.

Keywords: infertility; probiotics; vaginal microbiome.

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Conflict of interest statement

Matteo Cerboneschi is employed by the Company Next Genomic (a spin-off of University of Firenze). Personal Flora is a product distributed by PharmaBiotiX founded by V.P. Christine Allen is employed by the Reproductive Laboratory Services, LLC. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Flow diagram for a single-arm study of a probiotics treatment.
Figure 2
Figure 2
Box-plots of Chao1 index of species richness (A) in patient’s baseline and after administration of probiotics; box-plot of Shannon index (B).
Figure 3
Figure 3
The vaginal microbiota composition pre-intervention (baseline) and post-intervention (after administration of probiotics). (A) abundance at the phylum level; (B) abundance at the family-level; (C) genus-level abundance.
Figure 4
Figure 4
Radar chart of the species-level in patients’ baseline and patients after administration of probiotics. (A) Representation of the bacteria associated with healthy vaginal ecosystem; (B) representation of the species associated with infertility.
Figure 5
Figure 5
Characteristics of the types of community structures of the vaginal microbiome (CST). The proportion of the Community State Types (CSTs) in patients’ baseline (A) and after administration of probiotics (B).
Figure 6
Figure 6
Relationships between age, height, weight and BMI metrics, and vaginal microbiota composition (phylum, family, genus and species) in infertile patients receiving ART at baseline and following oral probiotic treatment.
See this image and copyright information in PMC

References

    1. Wei X., Tsai M.-S., Liang L., Jiang L., Hung C.-J., Jelliffe-Pawlowski L., Rand L., Snyder M., Jiang C. Vaginal microbiomes show ethnic evolutionary dynamics and positive selection of Lactobacillus adhesins driven by a long-term niche-specific process. Cell Rep. 2024;43:114078. doi: 10.1016/j.celrep.2024.114078. - DOI - PubMed
    1. Lehtoranta L., Ala-Jaakkola R., Laitila A., Maukonen J. Healthy Vaginal Microbiota and Influence of Probiotics Across the Female Life Span. Front. Microbiol. 2022;13:819958. doi: 10.3389/fmicb.2022.819958. - DOI - PMC - PubMed
    1. Ravel J., Gajer P., Abdo Z., Schneider G.M., Koenig S.S.K., McCulle S.L., Karlebach S., Gorle R., Russell J., Tacket C.O., et al. Vaginal microbiome of reproductive-age women. Proc. Natl. Acad. Sci. USA. 2011;108((Suppl. S1)):4680–4687. doi: 10.1073/pnas.1002611107. - DOI - PMC - PubMed
    1. Kwon M.S., Lee H.K. Host and Microbiome Interplay Shapes the Vaginal Microenvironment. Front. Immunol. 2022;13:919728. doi: 10.3389/fimmu.2022.919728. - DOI - PMC - PubMed
    1. Hugerth L.W., Krog M.C., Vomstein K., Du J., Bashir Z., Kaldhusdal V., Fransson E., Engstrand L., Nielsen H.S., Schuppe-Koistinen I. Defining Vaginal Community Dynamics: Daily microbiome transitions, the role of menstruation, bacteriophages, and bacterial genes. Microbiome. 2024;12:153. doi: 10.1186/s40168-024-01870-5. - DOI - PMC - PubMed

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