Study on the effects of an oral lactobacilli and lactoferrin complex in women with intermediate vaginal microbiota

General Gynecology

Abstract

Purpose

In the vagina of healthy reproductive-aged women, several microbial species maintain a finely tuned mutualistic relationship with the host providing the first-line of defense against the colonization by opportunistic pathogens, which are the leading cause of dysbiosis or vaginal infections (bacterial vaginosis, vulvovaginal candidiasis, and aerobic vaginitis). The use of probiotic lactobacilli to prevent vaginal infections has a good rationale, and an excellent safety record, but so far only a few strains have been clinically proven to be effective, particularly to prevent BV. The aim of the clinical trial was to evaluate the changes in Nugent score in women with intermediate vaginal microbiota treated with oral Lactobacillus acidophilus GLA-14 and Lactobacillus rhamnosus HN001 mixture, in combination with bovine lactoferrin RCX™ (Respecta®) or placebo, for 15 days.

Methods

Vaginal swabs were collected from each woman at baseline and at the end of probiotic treatment and analyzed by RT-PCR. Both symptoms of abnormal vaginal micorbiota and adverse effects were assessed throughout the study.

Results

The results showed that oral intake of lactobacilli/lactoferrin mixture led to significant vaginal colonization by L. acidophilus GLA-14 and L. rhamnosus HN001 showing that both strains can colonize vagina following oral ingestion. The effect of such colonization is correlated with the restoration of normal Nugent score (values 0–3) and an improvement of symptoms of abnormal vaginal micorbiota including itching and discharge.

Conclusions

Oral consumption of lactobacilli/lactoferrin complex corroborates the effectiveness of using lactobacilli for supporting vaginal health and provides a rational basis for future studies on vaginal infections.

Keywords

Lactobacillus acidophilus Lactobacillus rhamnosus Lactoferrin Respecta® Nugent score 

Notes

Acknowledgements

We are grateful to all the staff of Cebis International, Lugano (Switzerland) for their assistance in data management and clinical procedures and to all patients that participated to the study.

Author contributions

RR: Project development; data analysis; manuscript writing. AE: Data management; clinical operations. FDS: Project development; data analysis; manuscript writing.

Compliance with ethical standards

Conflict of interest

RR is employed by Giellepi. He had no influence on the interpretation of results. AE and FDS have no conflict of interest.

Ethical approval

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.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Giellepi S.p.A. Health ScienceLissoneItaly
  2. 2.Unit of Obstetrics and GynecologyUniversity of Medicine and Pharmacy Carol DavilaBucharestRomania
  3. 3.Department of Medical ScienceUniversity of TriesteTriesteItaly

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