Bacterial Vaginosis (BV)
Conditions
Interventions
Experimental group :Metronidazole sequential Vaginal quadruple Live Lactobacillus capsule KAL-001
Control group:metronidazole sequential Vaginal quadruple Live Lactobacillus capsule simulation agent
Sponsors
Beijing Tsinghua Chang Gung Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: (1) Women of childbearing age, between 18 and 55 years old (including boundary values) with sexual life history (2) Having regular menstrual cycles as judged by the investigator, and being able to use study drugs according to protocol requirements (3) During the screening visit, patients with clinical diagnosis of BV, that is, at least 3 of the Amsel standard clinical diagnosis results were positive (clue cell is a necessary condition), and Nugent score =7 (the diagnosis results of hospital within 3 days before signing the informed consent) (4) Subjects are willing to have no pregnancy plan from screening to receiving study drug treatment and agree to use effective contraception (no sex or full condom use for barrier contraception) for 3 months after drug withdrawal (5) Participate in the clinical trial voluntarily and can understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Known current patients with pelvic inflammatory disease, acute cervicitis, urinary tract infection requiring intervention and other acute infections of the urogenital system (2) Patients with vulvovaginal candidiasis (VVC), vaginal trichomoniasis, suspected gonorrhea, gonorrhea, herpes simplex virus infection, and/or condyloma acuminatum (CA) (3) Patients with other vaginal or vulvar disease conditions that would confuse the interpretation of clinical responses; (4) Patients with unexplained vaginal bleeding or known uterine fibroids, endometrial hyperplasia, or adenomyosis, for which the investigator believes intervention is required; (5) Patients had received topical or systemic antimicrobial therapy within 7 days prior to screening and/or expected to require such therapy during the trial period (6) Patients had a history of malignant tumor before screening and were considered unsuitable for inclusion by the investigators (7) Patients with a history of major gynecological surgery (deep wound and long recovery time) within 6 months prior to screening, or a history of superficial gynecological surgery or common procedures (including but not limited to Cyst of the greater vestibular gland cystotomy, Cyst of the greater vestibular gland abscess incision, contraceptive ring removal (placement), cervical or vaginal wall biopsy, cervical conectomy or cervical circular electrotomy) within 60 days prior to screening, Or within 60 days of the last termination at the time of screening (8) Gynecological examination results during screening showed obvious vaginal mucosal injury (such as mucosal edema, congestion, ulcer) (9) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times ULN, serum creatinine (Cr) >1.5 times ULN, urea nitrogen (BUN) >1.5 times ULN (10) In the investigator's judgment, there are any Comorbidity/co-operative surgery/medication/clinically significant laboratory abnormalities that may affect the evaluation of the investigational drug (11) Known allergy to similar drugs (such as vaginal Lactobacillus live capsules) or to metronidazole (12) Pregnant or lactating women (13) Participated in any intervention study within 30 days prior to the initial administration of the study, or was enrolled in or planned to be enrolled in any other intervention study during the study (14) The investigators determined that there are other medical conditions that might have influenced the results of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE;Physical examination;Vital signs;laboratory test;12-lead ECG;gynecologic examination;The recurrence rate of BV;Comprehensive cure rate;Bacterial cure rate;Changes in microbial community characteristics in vaginal secretions; | — |
Countries
China
Contacts
Public ContactLiao Qinping
Beijing Tsinghua Changgung Hospital
Outcome results
None listed