Characterization of the Vaginal Microbiota in Fertile Age: Correlations Clinical and Pathogenetic Correlations Among Gynecological Disorders.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Microbiota
研究概览
简要总结
Characterization of the vaginal microbiota of women under fertile age and study of correlations with gynecological disorders
详细描述
The study aimed to characterize, in women under fertile age, the composition and dynamics of the vaginal microbiota as well as to in-depth study correlations among microbiota and gynecological disorders
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 45 years;
- •Presence of at least one vaginal sign or symptom (leucorrhoea, burning, itching, and subjective vaginal discomfort);
- •Presence of at least 3 Amsel criteria;
- •Nugent score ≥ 7;
- •lactobacillary grade ≥ 2 (LBG) (according to Donders classification);
- •presence of blastospores and/or pseudohyphae evaluated by fresh mount microscopy
排除标准
- •Age < 18 years;
- •Nugent score < 7;
- •presence of sexually transmitted disease due to Chlamydia, Neisseria gonorrhoeae, or Trichomonas vaginalis as well as specific cervico-vaginitis or severe vulvovaginal symptoms related to acute candidiasis;
- •Clinically apparent herpes simplex infection;
- •Human papillomavirus or human immunodeficiency virus infections;
- •Use of antibiotic, antifungal, probiotic, or immunosuppressive drugs during the past four weeks;
- •Use of vaginal contraceptives;
- •Pregnancy or breastfeeding, chronic diseases, neoplastic disease, diabetes, genital tract bleeding)
结局指标
主要结局
Microbiota
时间窗: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Change from baseline in the composition of the vaginal microbiota with the increase of the cell density of lactobacilli (at least 3 log units) and decrease of pathogens (at least 2 log units) at the end of the treatment (10 days) and during the wash-out period (4 weeks after the end of the treatment)
Signs
时间窗: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Change from baseline of the Nugent score with values between 0 and 3 at the end of the treatment (10 days) and during the wash-out period (4 weeks after the end of the treatment)
Symptomatology
时间窗: Baseline; end of the treatment (10 days) ; wash-out (4 weeks)
Change from baseline of vulvovaginal erythema/edema, vulvar discomfort, burning, and itching
次要结局
- Wellbeing(Baseline; end of the treatment (10 days) ; wash-out (4 weeks))
研究者
Agnese Maria Chiara Rapisarda
doctor
Universita degli Studi di Catania