Oral Administration of Four Lactobacillus Species Preparation to Improve the Quality of the Neovaginal Flora in Male to Female Transsexual Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 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 penile linked neovaginal flora in male-to-female transsexuals after application of oral probiotics.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants underwent the sex reassignment surgery (SRS) with the technique of the inverted penile skin flap longer than 1 year.
- •All transsexual women treated according to the Standards of Care of the World Professional Association of Transgender Health (WPATH).
排除标准
- •clinical signs of vaginal or urinary tract infection,
- •abnormal neovaginal discharge,
- •neoplasia,
- •bleeding,
- •diarrhoea,
- •constipation,
- •rectal pathologies including hemorrhoids,
- •antibiotic therapy in the previous 4 weeks
研究组 & 干预措施
Lactobacilli
30 Participants with verum
干预措施: Probiotics (Dietary Supplement)
Placebo
30 Participants
干预措施: Placebo (Other)
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 day 7 of oral probiotic application
Using Nugent scoring system, from each participant first swab from neovagina and rectum will be taken before start of oral probiotic use.(baseline information) Second swab from neovagina and rectum will be taken on the day following the last administration.(information about change in Nugent)
次要结局
- Isolation of specific Lactobacilli from neovaginal microbiologic cultures after oral administration of probiotic(Day 7 of oral probiotic application)
研究者
Associate Prof. Ljubomir Petricevic MD
Ass. Prof MD
Medical University of Vienna