Study of Lactobacillus in Adjuvant Treatment of RVVC
Primary Purpose
Recurrent Vulvovaginal Candidiasis
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
clotrimazole vaginal tablets
Clotrimazole vaginal tablets+ Lactobacillus
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Vulvovaginal Candidiasis focused on measuring Recurrent Vulvovaginal Candidiasis, Lactobacillus, reproductive tract flora
Eligibility Criteria
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.)
Sites / Locations
- Dept Obstetrics and GynecologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Clotrimazole vaginal tablets
Clotrimazole vaginal tablets+ Lactobacillus
Arm Description
Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months
Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times + Lactobacillus Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months
Outcomes
Primary Outcome Measures
The cure rate of RVVC,
The cure rate of RVVC,
Secondary Outcome Measures
Recurrence of RVVC
Recurrence of RVVC
Full Information
NCT ID
NCT04699240
First Posted
January 5, 2021
Last Updated
May 4, 2023
Sponsor
Peking University Shenzhen Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04699240
Brief Title
Study of Lactobacillus in Adjuvant Treatment of RVVC
Official Title
A Prospective, Case-controlled Randomized Study of Human Reproductive Tract Active Lactobacillus in Adjuvant Treatment of Recurrent Vulvovaginal Candidiasis.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Shenzhen Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Vulvovaginal Candidiasis
Keywords
Recurrent Vulvovaginal Candidiasis, Lactobacillus, reproductive tract flora
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clotrimazole vaginal tablets
Arm Type
Active Comparator
Arm Description
Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months
Arm Title
Clotrimazole vaginal tablets+ Lactobacillus
Arm Type
Active Comparator
Arm Description
Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times + Lactobacillus Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months
Intervention Type
Drug
Intervention Name(s)
clotrimazole vaginal tablets
Other Intervention Name(s)
clotrimazole vaginal tablets(Bayer)
Intervention Description
Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months
Intervention Type
Drug
Intervention Name(s)
Clotrimazole vaginal tablets+ Lactobacillus
Other Intervention Name(s)
Clotrimazole vaginal tablets+ Lactobacillus(Umeta-mimi)
Intervention Description
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
Primary Outcome Measure Information:
Title
The cure rate of RVVC,
Description
The cure rate of RVVC,
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Recurrence of RVVC
Description
Recurrence of RVVC
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yiheng liang, M.D.
Phone
86-755-83923333
Ext
5518
Email
liangyiheng.cn@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ping liu, M.D.
Phone
86-755-83923333
Ext
5505
Email
253783006@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shangrong Fan, M.D.
Organizational Affiliation
Peking University Shenzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept Obstetrics and Gynecology
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiheng liang, M.D.
Phone
86-755-83923333
Ext
5518
Email
liangyiheng.cn@163.com
First Name & Middle Initial & Last Name & Degree
Piu liu, M.D.
Phone
86-755-83923333
Ext
5505
Email
253783006@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of Lactobacillus in Adjuvant Treatment of RVVC
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