Rapisarda Agnese Maria Chiara, Pino Alessandra, Grimaldi Raffaela Luisa, Caggia Cinzia, Randazzo Cinzia Lucia, Cianci Antonio
Department of General Surgery and Medical Surgical Specialties, University of Catania, Catania, Italy.
ProBioEtna SRL, Spin off of the University of Catania, Catania, Italy.
Front Surg. 2023 Jan 9;9:1075612. doi: 10.3389/fsurg.2022.1075612. eCollection 2022.
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 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 CA15 (DSM 33960) strain at 1.0 × 10 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 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 CA15 (DSM 33960) strain could be a safe and effective approach to restore and maintain a balanced vaginal microbiota.
益生菌在维持女性生殖道健康方面发挥着关键作用，是保障或恢复阴道微生物群稳态的一种有前景的替代方法。本随机双盲安慰剂对照研究旨在评估口服潜在益生菌CA15（DSM 33960）菌株平衡阴道生态失调女性阴道微生物群的能力。招募了60名有阴道生态失调体征和症状的女性，并将她们随机分配，每天一次口服含有1.0×10菌落形成单位的CA15（DSM 33960）菌株的胶囊或安慰剂，持续10天。在三个预定时间点评估临床和微生物学参数：基线时（T0）、治疗开始10天后（T1）以及治疗结束30天后（T2）。此外，通过世界卫生组织生活质量评估问卷，在基线时（T0）和治疗结束30天后（T2）评估生活质量。该益生菌耐受性良好，未报告副作用。口服潜在益生菌CA15（DSM 33960）菌株不仅在治疗开始10天后（T1），而且在治疗结束30天后（T2）都使临床体征和症状有了显著改善。通过微生物计数发现，在T1和T2采样时间点，潜在病原体显著减少，乳酸杆菌同时增加。此外，还报告了感知到的身体健康、社会关系和环境方面的改善。相比之下，安慰剂组的临床和微生物学参数以及生活质量几乎没有变化。潜在益生菌CA15（DSM 33960）菌株可能是恢复和维持阴道微生物群平衡的一种安全有效的方法。
