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NCT Number: NCT06821789

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

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.

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Key information

Conditions

Patients With Bacterial Vaginosis

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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).

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).

Primary outcomes

  1. Cure rate of bacterial vaginosis

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 12, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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