Bacterial Vaginosis (BV)
Conditions
Interventions
Experimental group 1:Low dose (1.0x10^7) vaginal tetracylactobacillus live capsule + metronidazole tablet simulant oral
Experimental group 2:Medium dose (1.0x10^8) for vaginal use of live Lactobacillus tetrabactyl capsule + metronidazole tablet simulant oral
Experimental group:High dose (1.0x10^9) vaginal use of live Lactobacillus tetrabactyl capsule + metronidazole tablet simulant oral
Control group:Vagina with quadruple Lactobacillus live bacteria capsule simulation agent +metronidazole tablets oral
Sponsors
Beijing Tsinghua Chang Gung Hospital
Eligibility
Sex/Gender
Female
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Women of childbearing age, between 20 and 50 years old (including boundary values) with sexual life history; 2. Have regular menstrual cycle (21-35 days), and can use study drugs continuously according to protocol requirements according to researchers' judgment; 3. During screening visit, Nugent score >=7 for patients with clinical diagnosis of BV (the diagnosis results of our hospital within 3 days before signing informed consent); 4. Negative blood pregnancy test; 5. 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 6 months after drug withdrawal, and shall not breastfeed; 6. Participate in the clinical trial voluntarily and can understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Positive for HPV16 and/or HPV16 and/or HPV16/18; 2. Known current patients with pelvic inflammatory disease, acute cervicitis, and acute infections of the genitourinary system; 3. Suffer from other infection causes of vulvovaginitis, such as aerobic vaginitis (AV, score >=4), vulvovaginal candidiasis, trichomoniasis vaginitis, suspected gonorrhea, herpes simplex virus infection and condyloma acuminatum, and the researchers think that the impact of the test evaluation; 4. Patients with other vaginal or vulvar disease conditions that would confuse the interpretation of clinical responses; 5. Used within 7 days prior to screening and used vaginal douching or other intravaginal therapy during the expected trial period; 6. Patients with unexplained vaginal bleeding or known uterine fibroids, endometrial hyperplasia, or adenomyosis, for which the investigator believes intervention is required; 7. Had received topical or systemic use within 14 days prior to screening and expected to require vaginal antifungal or antimicrobial therapy during the trial period; 8. A history of prescreening malignancy considered inappropriate for inclusion, except for adequately treated basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the cervix; 9. Patients with a history of gynecological surgery within 6 months before screening; 10. Gynecological examination results during screening showed obvious vaginal mucosal injury (such as mucosal edema, congestion, ulcer); 11. When screening, laboratory examination meets any of the following: (1) Hemoglobin (HGB) 1.5 times the upper limit of normal (ULN); (5) Urea/urea nitrogen (BUN) >1.5 times the upper limit of normal (ULN); (6) Alanine aminotransferase (ALT) >1.5 times the upper limit of normal value (ULN); (7) Aspartate aminotransferase (AST) >1.5 times the upper limit of normal value (ULN); (8) Alkaline phosphatase (ALP) >1.5 times the upper limit of normal (ULN); (9) Total bilirubin (TBIL) was higher than 1.5 times the upper limit of normal (ULN); 12. History of cardiovascular, liver, kidney, lung, digestive tract, nervous system, metabolic abnormalities, urinary and reproductive system, endocrine system, mental diseases and other serious diseases, which may affect the safety of the subjects according to the researchers; 13. Known allergy to any component of the test capsule (e.g., lactose, gelatin) and other similar drugs (e.g., Lactobacillus live capsule for vaginal use) or to metronidazole; 14. Those who received the novel coronavirus vaccine within 14 days and/or any other vaccine within 3 months prior to administration; 15. Within 60 days of the last termination of pregnancy at the time of screening; 16. A history of alcohol abuse, drug abuse or use of any drug in the six months prior to administration; 17. Infectious disease test positive [hepatitis B surface antigen (HBsAg) positive with HBV-DNA titer >1000 IU/mL, HCV, HIV-1, syphilis]; 18. Participated in any study during the 30 days preceding the study, or was enrolled in or planned to be enrolled in any other intervention study during the study; 19. The investigator determined that there were other medical conditions that might affect the judgment of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vaginal microecology; | — |
Secondary
| Measure | Time frame |
|---|---|
| subjective symptoms;adverse events;physical examination;vital signs;laboratory test;12-lead ECG;gynecologic examination; | — |
Countries
China
Contacts
Public ContactLiao Qinping
Outcome results
None listed