Observational Prospective Clinical Study on Lactobacillus plantarum in Women with Bacterial Vaginosis/Vaginitis
Background - We have analysed the role of Lactobacillus plantarum P 17630 in women with bacterial vaginosis/aerobic vaginitis.
Methods - We conducted an observational, prospective, multicenter study on women with a diagnosis of bacterial vaginosis/aerobic vaginitis treated or not treated with Lactobacillus plantarum P 17630 >100.000.000 UFC. Eligible for the study were women aged 18 years or more with one or more moderate/severe clinical symptom: itching, vaginal burning and dryness (evaluated according to a self reported four level scale: absent, mild, moderate and severe), diagnosis of bacterial vaginosis or aerobic vaginitis. At study entry women were asked about presence and intensity (on a four level scale: absent, mild, moderate and severe) of itching, vaginal burning and dryness and leucorrhea. The same information was also collected at follow up visit 15 days after study entry. Women were proposed together with specific treatment the use of Lactobacillus plantarum P 17630, according to the following schedule: 1 vaginal capsule for 6 consecutive days, then a capsule per week. For the purposes of this study, resolution of the clinical infection was defined as: absence of clue cells and negative results for at least 2 Amsel criteria (for bacterial vaginosis) and / or absence of clinical symptoms and vaginal pH normal or score Donders < 3 (for aerobic vaginitis) and/or culture negative.
Results - A total of 94 patients were enrolled: of those 48 (51.1%) were treated with Lactobacillus plantarum. At the follow up visit, 40 women treated with Lactobacillus plantarum reported clinical resolution (83.3%). The corresponding value in no treated women was 22 women (47.8%) (P<0.05). No adverse event was reported in both groups.
Conclusion - This observational study suggests that Lactobacillus plantarum given in association with specific treatment may improve clinical resolution in women with BV and aerobic vaginitis.