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

Effects of Lacticaseibacillus Rhamnosus LRa05 on Bacterial Vaginosis and Ovarian Function in Women: a Randomized, Double-blind, Placebo-controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patients With Bacterial Vaginosis
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; Conventional medication (ornidazole vaginal suppositories for 7 days) + maltodextrin, one strip/day (before meals);	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).
Experimental: Probiotic group; Conventional medication (ornidazole vaginal suppositories for 7 days) + 30B CFU/strip/day LRa05 (before meals);	Dietary supplement: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure rate of bacterial vaginosis	The Nugent score of ≤3 is considered successful in bacterial vaginosis treatment	8 weeks

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2025
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Genital Diseases, Female; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginosis, Bacterial; Vaginal Diseases
• Other Study ID Numbers: WK2025004

Drug and device information, study documents

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