Patients With Bacterial Vaginosis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
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).
DIETARY_SUPPLEMENTProbiotic
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).
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate of bacterial vaginosis | 8 weeks | The Nugent score of ≤3 is considered successful in bacterial vaginosis treatment |
Outcome results
None listed