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

NCT06821789 | Not Yet Recruiting

• 1 other identifier: WK2025004
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patients With Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• Cure rate of bacterial vaginosis

  The Nugent score of ≤3 is considered successful in bacterial vaginosis treatment

  8 weeks

Study Arms (2)

Probiotic group

EXPERIMENTAL

Conventional medication (ornidazole vaginal suppositories for 7 days) + 30B CFU/strip/day LRa05 (before meals);

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic 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).

Probiotic group

Placebo 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old, sexual activity, premenopausal women;
• Nugent score for diagnosing BV ≥7;
• Signed informed consent.

You may not qualify if:

• Mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;
• history of systemic organic disease or psychiatric illness;
• Planning pregnancy, breastfeeding, menstruation;
• within 5 days of the onset of the disease, any antibiotics have been used;
• long-term use of contraceptives or immunosuppressants;
• Allergic constitution or hypersensitivity to known components of the study drug.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: March 15, 2025
• Primary Completion: October 30, 2025
• Study Completion: May 30, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02