NCT06830122已完成不适用
Oral Lactobacillus Crispatus LCr86 Reduces Nugent Score and Improves Vaginal Microecology in Women With Intermediate Vaginal Microbiota
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Nugent score
研究概览
简要总结
Lactobacillus crispatus LCr86 was selected as a test preparation to evaluate its effect on the Nugent score, vaginal pH, vaginal microbiota composition, serum inflammatory cytokines, and functional prediction analyse.
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
- 19 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women of childbearing age over 19 years of age and under 50 years of age.
- •A person with a score of 4-6 on the Nugent core.
- •A person who agrees to participate in the human application test before the human application test begins and has prepared the written consent form.
- •A person who agrees to follow the contraception methods permitted by PI.
排除标准
- •Those who are currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal tract/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychiatric, infectious disease, tumor and malignant.
- •The subjects who treated for vaginal or urinary tract infection as of within 3 months (e.g., candidiasis, trichomonas infection, gonorrhea, chlamydial infection, etc.).
- •The subjects with vaginal or urinary tract bleeding, or abnormality.
- •The subjects who has been given antibiotics, antimicrobial agents, steroids, immunosuppressants, estrogen-based drugs (pneumonia-related drugs are allowed) within 4 weeks of visit 1 (but those who used them within 2 weeks of visit 1 cannot participate in the test).
- •The subjects who has consumed health functional foods related to improving immune function and vaginal health.
- •The subjects who has administered probiotics and prebiotics within two weeks based on visit 1 or has continuously administered or ingested fermented milk and lactobacillus products.
- •Allergic constitution or hypersensitivity to known components of the study drug.
- •The subjects who has received salivary treatment for sedimentation, women's cleansers, vaginal sanitizers, left fumigation, and vaginal health within two week of screening visit.
- •The subjects with unregulated hypertension (above 160mmHg or 90mmHg of blood pressure).
- •The subjects who AST (GOT) or ALT (GPT) is at least three times the normal limit of the testing agency.
- •The subjects who are sensitive or allergic to the ingredients of this human-applied test food.
- •Subjects who are pregnant, breastfeeding, or planning to conceive within three months.
- •If the daily alcohol intake is more than 20g.
- •Excessive smokers (≥20 pieces/day).
- •The subjects who has participated in another interventional clinical trial within three month of the commencement of this trial or who has a plan to participate in another interventional clinical trial (including a human application test) after the commencement of this human application test.
- •The subjects who is deemed inappropriate by the human application test testers for this human application test.
- •Other vaginitis: Trichomonas vaginalis (TV) infection or fungal infection.
研究组 & 干预措施
Placebo group
Placebo Comparator
maltodextrin, one strip/day;
干预措施: Placebo (Dietary Supplement)
Probiotic group
Experimental
10B CFU/strip/day LCr86;
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Change in Nugent score
时间窗: 8 weeks
Vaginal swab specimens were Gram-stained and independently scored by two trained professionals according to the standard method. Nugent scores range from 0 to 10, with scores of 0-3 considered normal, 4-6 indicating an intermediate state, and 7-10 suggesting bacterial vaginosis.
次要结局
未报告次要终点
研究者
研究点 (1)
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