Effects of Lacticaseibacillus Rhamnosus LRa05 on Bacterial Vaginosis and Ovarian Function in Women

Not Applicable

Not yet recruiting

• Conditions: Patients With Bacterial Vaginosis

• Registration Number: NCT06821789
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief Summary

In this study, Lacticaseibacillus rhamnosus LRa05 was selected as test preparations to observe the clinical efficacy in the intervention trial of combined antibiotic therapy, and to evaluate its effects on the cure rate, recurrence rate and vaginal microbiota of patients with bacterial vaginitis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-12
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-19
• Study Start: 2025-03-15
• Primary Completion: 2025-10-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

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

Inclusion Criteria

1. 18 to 65 years old, sexual activity, premenopausal women;
2. Nugent score for diagnosing BV ≥7;
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 disease or psychiatric illness;
3. Planning pregnancy, breastfeeding, menstruation;
4. within 5 days of the onset of the disease, any antibiotics have been used;
5. long-term use of contraceptives or immunosuppressants;
6. Allergic constitution or hypersensitivity to known components of the study drug.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cure rate of bacterial vaginosis	8 weeks	The Nugent score of ≤3 is considered successful in bacterial vaginosis treatment