Background. Bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) are common conditions that significantly impact the quality of life for women of reproductive age. Although standard treatments for BV and VVC are effective at alleviating acute symptoms, they often fail to restore the vaginal microbiota in the long term.

Aim. To evaluate the efficacy and safety of oral multiprobiotics as part of the comprehensive therapy for BV and VVC.

Materials and methods. A prospective, randomized, double-blind, placebo-controlled, parallel study was conducted involving 180 patients of reproductive age. The cohort comprised 90 individuals with confirmed BV and 90 with VVC. Patients were randomized into four groups: BV with probiotic (n = 50), BV with placebo (n = 40), VVC with probiotic (n = 50), and VVC with placebo (n = 40). The investigational agent was a multiprobiotic formulation containing Lactobacillus rhamnosus, L. plantarum, L. helveticus, L. gasseri, and L. crispatus. The treatment duration was one month. Parameters assessed included changes in clinical symptoms (using a 10-point scale), vaginal pH, vaginal microflora composition (analyzed via real-time polymerase chain reaction using Femoflor-16), and patient satisfaction with treatment outcomes.

Results. The addition of the multiprobiotic from the initiation of standard therapy significantly contributed to the restoration of normal vaginal microbiota composition, evidenced by a substantial increase in the proportion of Lactobacillus spp. (p < 0.001), normalization of vaginal pH and more pronounced relief of clinical symptoms compared to placebo (p < 0.001), and increased patient satisfaction with the treatment outcomes (p < 0.05). Specifically, the increase in Lactobacillus spp. in the BV + probiotic group was 33.3% vs. 14.4% in the placebo group (p < 0.001), while in the VVC + probiotic group, it was 19.8% vs. 6.7% (p < 0.001). According to Femoflor-16 data, the absolute increase in Lactobacillus spp. concentration in the BV + probiotic group was 1.8 times greater (+3.48lg vs. +1.94lg), and the reduction of BV-associated anaerobes was 1.8–2.3 times more significant than in the placebo group (all p < 0.001). For the VVC + probiotic group, the elimination of Candida spp. was 1.4 times more pronounced (-3.86lg vs. -2.72lg; p < 0.001), and the increase in lactobacilli was six times greater. Additionally, significant reductions in Staphylococcus spp., Streptococcus spp., and Enterobacteriaceae were documented in the probiotic group, with no similar changes observed in the placebo group. Patients diagnosed with VVC exhibited a significant decrease in pH levels by 0.46 units (p < 0.001). Following therapy, the probiotic groups presented statistically significant reductions in clinical symptom severity when compared with the placebo groups (p < 0.001). In BV patients, the intensity of abnormal discharge averaged 1.2 ± 0.8 points vs. 2.1 ± 1.2 points, and the unpleasant odor intensity averaged 0.8 ± 0.6 points vs. 1.5 ± 0.9 points. In VVC patients, the severity of itching and burning was recorded at 0.9 ± 0.7 points vs. 1.8 ± 1.1 points. Treatment satisfaction was notably higher in the probiotic groups: 88% vs. 70% for BV (p = 0.034) and 86% vs. 65% for VVC (p = 0.019).

Conclusions. The findings of this study support the inclusion of oral multiprobiotics that contain combinations of L. rhamnosus, L. plantarum, L. helveticus, L. gasseri, and L. crispatus in comprehensive treatment regimens from the first day of therapy for BV and VVC, as this approach enhances treatment efficacy and may reduce the risk of relapse.