Study of Lactobacillus in Adjuvant Treatment of RVVC

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

Detailed Description
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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.

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

Conditions
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Recurrent Vulvovaginal Candidiasis

Intervention / Treatment
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* Drug: clotrimazole vaginal tablets
* Drug: Clotrimazole vaginal tablets+ Lactobacillus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clotrimazole vaginal tablets<br>Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months | Drug: clotrimazole vaginal tablets<br>* Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months<br>* Other names: clotrimazole vaginal tablets（Bayer）;|
| Active Comparator: Clotrimazole vaginal tablets+ Lactobacillus<br>Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times + Lactobacillus Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months | Drug: Clotrimazole vaginal tablets+ Lactobacillus<br>* Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months Human Reproductive Tract Active Lactobacillus,4g,qd ,3months<br>* Other names: Clotrimazole vaginal tablets+ Lactobacillus（Umeta-mimi）;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cure rate of RVVC, | The cure rate of RVVC, | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of RVVC | Recurrence of RVVC | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent Vulvovaginal Candidiasis, Lactobacillus, reproductive tract flora