Study of Lactobacillus in Adjuvant Treatment of RVVC

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

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

Study Overview

• Status: Recruiting
• Conditions: Recurrent Vulvovaginal Candidiasis
• Intervention / Treatment: Drug: clotrimazole vaginal tablets; Drug: Clotrimazole vaginal tablets+ Lactobacillus

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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yiheng liang, M.D.; Phone Number: 5518 86-755-83923333; Email: liangyiheng.cn@163.com
• Study Contact Backup: Name: Ping liu, M.D.; Phone Number: 5505 86-755-83923333; Email: 253783006@qq.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518036
      • Recruiting
      • Dept Obstetrics and Gynecology
      • Contact: Yiheng liang, M.D.; Phone Number: 5518 86-755-83923333; Email: liangyiheng.cn@163.com
      • Contact: Piu liu, M.D.; Phone Number: 5505 86-755-83923333; Email: 253783006@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 52 years (Adult)
• Accepts Healthy Volunteers: No

Description

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:

1. Taking / injecting antibiotics in the past two weeks;
2. A woman who intends to be pregnant, pregnant or lactating;
3. Long term use of contraceptives and immunosuppressants;
4. Postmenopausal;
5. There was no same fixed sexual partner (RSP) before and after treatment
6. 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;
7. 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.)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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）

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University Shenzhen Hospital
• Investigators: Principal Investigator: Shangrong Fan, M.D., Peking University Shenzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Lactobacillus; Recurrent Vulvovaginal Candidiasis; reproductive tract flora
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Recurrence; Candidiasis, Vulvovaginal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Clotrimazole; Miconazole
• Other Study ID Numbers: pkuszh-2020-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No