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Effect of vaginal probiotics containing Lactobacillus casei rhamnosus (Lcr regenerans) on vaginal dysbiotic microbiota and pregnancy outcome, prospective, randomized study.
Petricevic, L, Rosicky, I, Kiss, H, Janjic, N, Kaufmann, U, Holzer, I, Farr, A
Scientific reports. 2023;13(1):7129
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Preterm delivery (PTD) of babies is thought in some women to be associated with the development of vaginal infections. An imbalance in the bacteria normally present in the vagina and especially a lack of Lactobacillus species can develop into a condition known as bacterial vaginosis (BV), which is a risk factor for PTD. The use of antibiotics is the standard treatment, however concerns on its effectiveness in preventing PTB have been raised. Antibiotics not only eradicate the abnormal bacteria, but also the Lactobacillus. This randomised control trial of 129 women with BV aimed to determine the effect of vaginally applied lactobacilli on the restoration of normal bacteria in the vagina and the rate of PTD. The results showed that women who had a complete lack of Lactobacillus, the vaginal application of Lactobacillus casei rhamnosus, BV was improved and gestational age at delivery and birthweight were both significantly increased, although PTD rate was not. It was concluded that vaginally applied Lactobacillus may be of some benefit to women with BV during pregnancy. This study could be used by healthcare professionals to understand the importance of vaginal microbiota during pregnancy. However, this was a study of very small numbers of women and larger studies are needed before vaginally applied microbiota can be definitively recommended.
Abstract
The intermediate bacterial microbiota is a heterogeneous group that varies in the severity of the dysbiosis, from minor deficiency to total absence of vaginal Lactobacillus spp. We treated women with this vaginal dysbiosis in the first trimester of pregnancy using a vaginally applied lactobacilli preparation to restore the normal microbiota in order to delay the preterm delivery rate. Pregnant women with intermediate microbiota of the vagina and a Nugent score of 4 were enrolled in two groups: intermediate vaginal microbiota and a Nugent score of 4 with lactobacilli (IMLN4) and intermediate vaginal microbiota and a Nugent score of 4 without lactobacilli (IM0N4), with and without vaginal lactobacilli at baseline, respectively. Half of the women in each group received the treatment. Among women without lactobacilli (the IM0N4 group), the Nugent sore decreased by 4 points only in the women who received treatment, and gestational age at delivery and neonatal birthweight were both significantly higher in the treated subgroup than in the untreated subgroup (p = 0.047 and p = 0.016, respectively). This small study found a trend toward a benefit of treatment with vaginal lactobacilli during pregnancy.
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Long-term Lactobacillus rhamnosus BMX 54 application to restore a balanced vaginal ecosystem: a promising solution against HPV-infection.
Palma, E, Recine, N, Domenici, L, Giorgini, M, Pierangeli, A, Panici, PB
BMC infectious diseases. 2018;18(1):13
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There is increasing interest in the role that the vaginal microbiome (the bacterial profile) plays in women’s health. Lactobacilli are the most dominant vaginal bacteria present in healthy women and it is known that when the bacteria get out of balance (a state called dysbiosis), disorders such as vaginosis and sexually transmitted diseases such as the Human Papilloma Virus (HPV) increase. This randomised pilot study aimed to investigate whether long-term use of Lactobacillus rhamnosus in women with dysbiosis and HPV-infection had an impact on treatment outcomes. 117 women with diagnosed vaginosis or vaginitis and HPV-infection were treated with standard antibiotic therapy and then randomly assigned to receive either 2-months or 6 months of vaginal Lactobacillus. At the median follow-up of 14 months post treatment, more than double the number of women in the 6-month probiotic treatment group received a negative HPV-pap smear, when compared to the 2-month treatment group. Randomised controlled trials are required to further this research, however Nutrition Practitioners working with women with vaginosis/vaginitis may want to consider the possible use of probiotics to support a healthy vaginal microbiome.
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).