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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorWecare Probiotics Co., Ltd.

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 to 65 years old, sexual activity, premenopausal women;

Nugent score for diagnosing BV ≥7;

Signed informed consent.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Probiotic groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cure rate of bacterial vaginosis

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

Time frame
8 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: