Long-term Lactobacillus rhamnosus BMX 54 application to restore a balanced vaginal ecosystem: a promising solution against HPV-infection

Ettore Palma, Nadia Recine, Lavinia Domenici, Margherita Giorgini, Alessandra Pierangeli, Pierluigi Benedetti Panici, Ettore Palma, Nadia Recine, Lavinia Domenici, Margherita Giorgini, Alessandra Pierangeli, Pierluigi Benedetti Panici

Abstract

Background: Over recent years, a growing interest has developed in microbiota and in the concept of maintaining a special balance between Lactobacillus and other bacteria species in order to promote women's well-being. The aim of our study was to confirm that vaginal Lactobacilli long-lasting implementation in women with HPV-infections and concomitant bacterial vaginosis or vaginitis might be able to help in solving the viral infection, by re-establishing the original eubiosis.

Methods: A total of 117 women affected by bacterial vaginosis or vaginitis with concomitant HPV-infections were enrolled at Department of Gynecological Obstetrics and Urological Sciences, La Sapienza University, Rome, Italy between February 2015 and March 2016. Women were randomized in two groups, standard treatment (metronidazole 500 mg twice a day for 7 days or fluconazole 150 mg orally once a day for 2 consecutive days) plus short-term (3 months) vaginal Lactobacillus implementation (group 1, short probiotics treatment protocol group, n = 60) versus the same standard treatment plus long-lasting (6 months) vaginal Lactobacillus rhamnosus BMX 54 administration (group 2, treatment group, n = 57).

Results: After a median follow up of 14 months (range 9-30 months) the chance to solve HPV-related cytological anomalies was twice higher in probiotic long-term users (group 2) versus short probiotics implementation group (group 1) (79.4% vs 37.5%, p = 0.041). Moreover, a total HPV-clearance was shown in 11.6% of short schedule probiotics implementation patients compared to a percentage of 31.2% in vaginal Lactobacilli long term users (p = 0.044), assessed as negative HPV-DNA test documented at the end of the study period.

Conclusions: The consistent percentage of clearance of PAP-smear abnormalities and HPV-clearance obtained in long-term treatment group has been interestingly high and encouraging. Obviously, larger and randomized studies are warranted to confirm these encouraging results, but we believe that eubiosis re-establishment is the key to tackle effectively even HPV-infection.

Trial registration: Retrospectively registered on PRS NCT03372395 (12/12/2017).

Keywords: HPV infection; Lactobacillus rhamnosus BMX 54; Probiotics.

Conflict of interest statement

Ethics approval and consent to participate

Institutional Review Board approved the study (Clinical Trial Centre, Policlinico Umberto I Hospital, Rome-Italy). Written informed consent was collected from all patients enrolled. 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.

Consent for publication

Not applicable.

Competing interest

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart. t0: time of inclusion; t3, t6 and t9: follow up time at 3, 6 and 9 months respectively
Fig. 2
Fig. 2
Trend of HPV abnormalities resolution in the two groups (group 1 – short probiotics implementation group, n = 60; group 2 – long probiotics implementation group, n = 57; p = 0.041)
Fig. 3
Fig. 3
HPV clearance at the end of follow up period (t9) in the two groups (group 1 – short probiotics implementation group, n = 60; group 2 – long probiotics implementation group, n = 57). HPV clearance was significantly higher in long term probiotics users than in the other group (p = 0.044). t0: before treatment; t9: after 9 months follow up

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