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临床试验/NCT04699240
NCT04699240已完成4 期

A Prospective, Case-controlled Randomized Study of Human Reproductive Tract Active Lactobacillus in Adjuvant Treatment of Recurrent Vulvovaginal Candidiasis.

Peking University Shenzhen Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
The cure rate of RVVC,

研究概览

简要总结

We are trying to determine if Clotrimazole vaginal tablets with oral Lactobacillus is better than Clotrimazole vaginal tablets in Preventing the Recurrence of vulvovaginalcandidiasis

详细描述

vulvovaginal candidiasis is common disease in women. Its refractory and high recurrence rate has always been a clinical problem. Some cases even recur several times a year, and those who recur more than four times a year are diagnosed as recurrent vaginal candidal infection Candidiasis, RVVC)。 The common clinical regimen for VVC is to strengthen and consolidate clotrimazole vaginal tablets for up to 25 weeks. However, long-term antibiotic treatment will lead to the decrease of vaginal microflora and the disappearance of inflammation and pathogenic bacteria, which will greatly increase the probability of repeated infection and become a barrier to clinical treatment. If probiotics are added in the treatment, the abundance of lactobacillus can be ensured while antibiotic treatment is carried out, the homeostasis of reproductive tract flora can be reestablished, the defense mechanism can be improved fundamentally, and the re invasion of pathogenic bacteria can be reduced, which will become a new treatment idea and method for radical cure of refractory RVVC.

We hypothesize that Clotrimazole vaginal tablets with oral Lactobacillus is better than Clotrimazole vaginal tablets in Preventing the Recurrence of vulvovaginalcandidiasis.

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
None

入排标准

年龄范围
18 Years 至 52 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women be at least 18 years of age
  • Have symptoms of vulva irritation and or abnormal discharge
  • Meet the clinical criteria for RVVC
  • Willing to participate in research

排除标准

  • Taking / injecting antibiotics in the past two weeks;
  • A woman who intends to be pregnant, pregnant or lactating;
  • Long term use of contraceptives and immunosuppressants;
  • Postmenopausal;
  • There was no same fixed sexual partner (RSP) before and after treatment
  • Patients with severe gastrointestinal diseases, including colorectal cancer, IBS, IBD, chronic or acute diarrhea, long-term constipation, etc., or receiving gastrointestinal surgery and abdominal surgery within one year, such as cholecystectomy;
  • Patients with severe heart, liver and kidney dysfunction, mental diseases, infectious diseases, tumors, severe anemia, and severe autoimmune diseases (such as rheumatoid arthritis, lupus erythematosus, etc.)

研究组 & 干预措施

Clotrimazole vaginal tablets

Active Comparator

Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months

干预措施: clotrimazole vaginal tablets (Drug)

Clotrimazole vaginal tablets+ Lactobacillus

Active Comparator

Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times + Lactobacillus Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months

干预措施: Clotrimazole vaginal tablets+ Lactobacillus (Drug)

结局指标

主要结局

The cure rate of RVVC,

时间窗: 6 months

The cure rate of RVVC,

次要结局

  • Recurrence of RVVC(6 months)

研究者

发起方
Peking University Shenzhen Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shangrong Fan

Profesor

Peking University Shenzhen Hospital

研究点 (1)

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