Study of Lactobacillus in Adjuvant Treatment of RVVC

Sponsor

Peking University Shenzhen Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04699240

Collaborator

(none)

140

Enrollment

Location

Arms

35.9

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Recurrent Vulvovaginal Candidiasis	Drug: clotrimazole vaginal tablets Drug: Clotrimazole vaginal tablets+ Lactobacillus	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Clotrimazole vaginal tablets 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 Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months Other Names: clotrimazole vaginal tablets（Bayer）
Active Comparator: Clotrimazole vaginal tablets+ Lactobacillus 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 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 Other Names: Clotrimazole vaginal tablets+ Lactobacillus（Umeta-mimi）

Arm

Intervention/Treatment

Active Comparator: Clotrimazole vaginal tablets

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

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

Other Names:

clotrimazole vaginal tablets（Bayer）

Active Comparator: Clotrimazole vaginal tablets+ Lactobacillus

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

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

Other Names:

Clotrimazole vaginal tablets+ Lactobacillus（Umeta-mimi）

Outcome Measures

Primary Outcome Measures

The cure rate of RVVC, [6 months]
The cure rate of RVVC,

Secondary Outcome Measures

Recurrence of RVVC [6 months]
Recurrence of RVVC

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 52 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.)