Effects of Lactobacillus Crispatus LCr86 on Bacterial Vaginosis and Ovarian Function in Women

NCT ID: NCT06830122

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2026-04-30

Brief Summary

Lactobacillus crispatus LCr86 was selected as a test preparation to observe its clinical efficacy in an intervention trial of combined antibiotic treatment and evaluate its effect on the cure rate, recurrence rate and vaginal flora of patients with bacterial vaginitis.

Conditions

Patients With Bacterial Vaginosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotic group

Conventional medication (ornidazole vaginal suppositories for 7 days) + 30B CFU/strip/day LCr86 (before meals);

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

The experimental phase of this study will last 8 weeks and each subject will receive 4 follow-up visits (week 0, week 4, week 8, week 20).

Placebo group

Conventional medication (ornidazole vaginal suppositories for 7 days) + maltodextrin, one strip/day (before meals);

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

The experimental phase of this study will last 8 weeks and each subject will receive 4 follow-up visits (week 0, week 4, week 8, week 20).

Interventions

Probiotic

The experimental phase of this study will last 8 weeks and each subject will receive 4 follow-up visits (week 0, week 4, week 8, week 20).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The experimental phase of this study will last 8 weeks and each subject will receive 4 follow-up visits (week 0, week 4, week 8, week 20).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. 18 to 65 years of age, history of sexual activity, premenopausal women;

2. Nugent score ≥ 7 for diagnosis of BV;

3. Signed informed consent.

Exclusion Criteria

1. Mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection, or gonococcal vaginitis;

2. History of systemic organic or psychiatric disease;

3. Planned pregnancy, breastfeeding, or menstruation;

4. Have used any antibiotics within 5 days of disease onset;

5. Long-term use of contraceptives or immunosuppressants;

6. Hypersensitivity or allergy to known components of the study drug.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

WK2025005

Identifier Type: -

Identifier Source: org_study_id