Lactobacilli Implementation to Restore a Balanced Vaginal Ecosystem: a Promising Solution Against Vaginosis, Vaginitis and HPV Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 主要终点
- Evaluation of a possible role of probiotics in vaginal infections resolution
研究概览
简要总结
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 the study was to confirm that vaginal Lactobacilli long-lasting implementation in women with HPVinfections and concomitant bacterial vaginosis or vaginitis might be able to help in solving the viral infection, by re-establishing the original eubiosis.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age>18 years
- •documented BV or yeast vaginitis associated with HPV-infection documented as PAP-smear abnormalities (ASCUS, L-SIL or H-SIL histologically demonstrated as CIN1) and/or positive for HPV-DNA
排除标准
- •pregnancy or breastfeeding
- •previous abnormal PAP-smear
- •concomitant malignancies
- •immunological diseases
- •severe comorbidities
- •prolonged corticosteroid treatment.
研究组 & 干预措施
Group 1
Standard treatment plus short-term (3 months) vaginal Lactobacillus rhamnosus BMX 54 implementation
干预措施: Lactobacillus rhamnosus BMX 54 (Other)
Group 2
Standard treatment plus long-lasting (6 months) Lactobacillus rhamnosus BMX 54 administration
干预措施: Lactobacillus rhamnosus BMX 54 (Other)
结局指标
主要结局
Evaluation of a possible role of probiotics in vaginal infections resolution
时间窗: 9 months
Changes in clinical responses (absence of typical symptoms associated with vaginal infections)
次要结局
- Treatment-related adverse events record(9 months)
研究者
Pierluigi Benedetti Panici
Full Professor and Director of Dept Obstetrics and Gynecology
University of Roma La Sapienza