The Ability of an Orally Administered Preparation of Four Lactobacillus Species to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy. A Prospective Randomized Placebo-controlled, Double-blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- change in Nugent score between baseline and end of treatment (improvement or no improvement)
研究概览
简要总结
The aim of this study is the improvement of the vaginal flora by at least two grades of the Nugent scale after application of oral probiotics.
详细描述
The aim of this study is the improvement of the vaginal flora by at least two grades of the Nugent scale. Improvement of Nugent scores should be considered the primary end point of the study. The outcome of the study would be considered positive if significantly more women in the verum cohort achieve such improvement than in the placebo cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Only women with breast cancer and neoadjuvant / adjuvant chemotherapy, at least 4 weeks postoperative, without vaginal bleeding without abnormal vaginal discharge, Only women with Nugent scores between 4 and 6
排除标准
- •Patients with diarrhoea, constipation, vaginal or urinary tract infection requiring antibacterial treatment and women receiving antibiotic therapy in the previous 4 weeks.
结局指标
主要结局
change in Nugent score between baseline and end of treatment (improvement or no improvement)
时间窗: day 0, 7 and day 14 of oral probiotic application
Using Nugent scoring system, from each participant first swab from the vagina will be taken before start of oral probiotic use.(baseline information) Second swab will be taken on the day following the last administration.(information about change in Nugent)
次要结局
- Isolation of specific Lactobacilli from vaginal microbiologic cultures after oral administration of probiotic(day 0, 7 and day 14 after oral probiotic application)
研究者
Associate Prof. Ljubomir Petricevic MD
Assistant Professor
Medical University of Vienna