Lacticaseibacillus rhamnosus CA15 (DSM 33960) strain as a new driver in restoring the normal vaginal microbiota: A randomized, double-blind, placebo-controlled clinical trial

Abstract

Probiotics play a key role in maintaining the health of the female reproductive tract, representing a promising alternative to safeguard or restore the homeostasis of the vaginal microbiota. The present randomized double-blind placebo-controlled study was performed to evaluate the ability of the potential probiotic Lacticaseibacillus rhamnosus CA15 (DSM 33960) strain, orally administrated, to balance the vaginal microbiota of women with vaginal dysbiosis. Sixty women, with signs and symptoms of vaginal dysbiosis, were recruited and randomly allocated to receive oral capsules containing the L. rhamnosus CA15 (DSM 33960) strain at 1.0 × 1010 colony-forming units or placebo once daily for 10 days. Clinical and microbiological parameters were evaluated in three scheduled appointments: at baseline (T0), 10 days after the start of the treatment (T1), and 30 days after the end of the treatment (T2). In addition, the quality of life, through the WHO quality of life assessment questionnaire, was assessed at baseline (T0) and 30 days after the end of the treatment (T2). The probiotic was well tolerated and no side effects were reported. The oral consumption of the potential probiotic L. rhamnosus CA15 (DSM 33960) strain determined a significant improvement of both clinical signs and symptoms not only 10 days after the start of the treatment (T1) but also 30 days after the end of the treatment (T2). A significant reduction of potential pathogens and a concomitant increase of lactobacilli was revealed, by microbial count, at both T1 and T2 sampling times. In addition, the enhancement of the perceived physical health, social relations, and environment was reported. Differently, in placebo group clinical and microbiological parameters as well as quality of life remained almost unchanged. The potential probiotic L. rhamnosus CA15 (DSM 33960) strain could be a safe and effective approach to restore and maintain a balanced vaginal microbiota.

Use of probiotic lactobacilli in the treatment of vaginal infections: In vitro and in vivo investigations

“…Participants taking daily oral probiotic lactobacilli capsules can lead to a substantial improvement in the vaginal flora in terms of an increase in lactobacilli and a decrease in enterococci, staphylococci, Gardnerella spp., and Candida spp. in mixed vaginal infected patients ( Pino et al., 2022b ; Rapisarda et al., 2023 ).…”

Avaliação do efeito dos probióticos na saúde vaginal: revisão integrativa

“…Eles têm sido amplamente utilizados no tratamento de desregulações intestinais, mas seu efeito no trato reprodutivo feminino ainda é controverso (JEPSEN et al, 2022). Ao que parece, os probióticos são capazes de desempenhar um importante papel na manutenção da estabilidade do microambiente vaginal, melhorando a frente imunológica e bloqueando a progressão de câncer cervical (RAPISARDA et al, 2023).…”

“…A saúde vaginal das diferentes mulheres está constantemente influenciada e determinada pela composição e aspectos de seu microbioma (JEPSEN et al, 2022). O manejo dietético e o uso de probióticos podem apresentar potenciais resultados no tratamento de patologias (RAPISARDA et al, 2023).…”