Effects of Lacticaseibacillus Rhamnosus LRa05 on Bacterial Vaginosis and Ovarian Function in Women: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Cure rate of bacterial vaginosis
研究概览
简要总结
In this study, Lacticaseibacillus rhamnosus LRa05 was selected as test preparations to observe the clinical efficacy in the intervention trial of combined antibiotic therapy, and to evaluate its effects on the cure rate, recurrence rate and vaginal microbiota of patients with bacterial vaginitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 to 65 years old, sexual activity, premenopausal women;
- •Nugent score for diagnosing BV ≥7;
- •Signed informed consent.
排除标准
- •Mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;
- •history of systemic organic disease or psychiatric illness;
- •Planning pregnancy, breastfeeding, menstruation;
- •within 5 days of the onset of the disease, any antibiotics have been used;
- •long-term use of contraceptives or immunosuppressants;
- •Allergic constitution or hypersensitivity to known components of the study drug.
研究组 & 干预措施
Placebo group
Conventional medication (ornidazole vaginal suppositories for 7 days) + maltodextrin, one strip/day (before meals);
干预措施: Placebo (Dietary Supplement)
Probiotic group
Conventional medication (ornidazole vaginal suppositories for 7 days) + 30B CFU/strip/day LRa05 (before meals);
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Cure rate of bacterial vaginosis
时间窗: 8 weeks
The Nugent score of ≤3 is considered successful in bacterial vaginosis treatment
次要结局
未报告次要终点