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

Not Applicable

Not yet recruiting

• Conditions: Patients With Bacterial Vaginosis

• Registration Number: NCT06830122
• Lead Sponsor: Wecare Probiotics Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17
• Study Start: 2025-03-20
• Primary Completion: 2025-09-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cure rates for bacterial vaginitis	8 weeks	The Nugent score of ≤3 is considered successful in bacterial vaginosis treatment.