Bacterial vaginosis (BV)
Conditions
Interventions
Control group:Simultaneous administration of XLF055 mimicant and metronidazole, 1 capsule of XLF055 mimicant each time, once a day, vaginal administration, for 14 consecutive days. Take metronidazole
Experimental Group:Simultaneous administration of XLF055 and metronidazole: XLF055(Lactobacillus not less than 1.0x108 CFU/g) 1 capsule each time, once a day, vaginal administration, for 14 consecutiv
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Women of childbearing age aged 18 to 55 (including the boundary value) with a history of sexual life. 2. The menstrual cycle is relatively regular, and as determined by the researcher, the investigational drugs can be continuously used as required by the protocol. 3. During the screening visit, patients with a clinical diagnosis of bacterial vaginosis (BV), that is, those with at least three abnormal Amsel standard clinical diagnosis results, among which positive clue cells are a necessary condition, and the Nugent score is >=7 points (the diagnosis results of the baseline vaginal secretion microecological test within 3 days before randomization). 4. During the period from screening to receiving the study drug treatment and within 3 months after drug withdrawal, the subjects had no pregnancy plans and agreed to take effective contraceptive measures (no sexual activity or full use of condoms for barrier contraception). 5. Voluntarily participate in this clinical trial and be able to understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those currently known to be suffering from pelvic inflammatory disease, acute cervicitis and acute infection of the urinary and reproductive systems, and whom the researchers consider to affect the evaluation of the trial. 2. Those who suffer from vaginitis caused by other infectious reasons, such as aerobic vaginitis (AV, score >=4 with clinical symptoms), vulvovaginal candidiasis (VVC), vaginal trichomoniasis, etc., and whom the researchers consider to affect the evaluation of the test. 3. Patients with other vaginal or vulvar disease conditions who may confuse the interpretation of clinical responses. 4. Unexplained vaginal bleeding or known cases of uterine fibroids, endometrial hyperplasia or adenomyosis, which researchers believe require intervention treatment. 5. Those who have received local or systemic antimicrobial treatment within 7 days prior to screening or within 5 half-lives of known drugs (whichever is longer), and/or are expected to need such treatment during the trial period. 6. For those with a history of malignant tumors before screening and who are considered unsuitable for inclusion by the researchers, the following situations are excluded: well-treated basal cell carcinoma or squamous cell carcinoma of the skin, and cervical carcinoma in situ. 7. Those who meet any of the following laboratory tests during screening: hemoglobin (HGB) 1.5 times the upper limit of the normal value (ULN); Urea (BU)/urea nitrogen (BUN) >1.5 times the upper limit of the normal value (ULN); Alanine aminotransferase (ALT) >3.0 times the upper limit of normal value (ULN); Aspartate aminotransferase (AST) >3.0 times the upper limit of the normal value (ULN); Alkaline phosphatase (ALP) >3.0 times the upper limit of normal value (ULN); Total bilirubin (TBIL) >3.0 times the upper limit of the normal value (ULN). 8. The subject has a history of major diseases such as cardiovascular, liver, kidney, lung, digestive tract, nervous system, metabolic disorders, urinary and reproductive system, endocrine system, and mental illness, which the researcher determines may affect the safety of the subject. 9. Those who are known or suspected of being allergic to any component of the investigational drug (such as lactose). 10. Those who have received any other vaccine within one month prior to administration and/or are expected to receive the vaccine during the trial period. 11. Pregnant or lactating women, or those whose screening or baseline blood pregnancy test results show pregnancy. 12. Those who have a history of alcohol abuse, drug abuse or have used any drugs within 6 months prior to administration. 13. The patient has participated in any clinical trial study within 30 days prior to the first administration of the drug, or has been enrolled in or plans to be enrolled in any other intervention study during the period of participating in this study. 14. The researcher determines that there are other medical conditions that may affect the evaluation of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The recurrence rate of BV within 90 days after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The recurrence rate of BV within 30 and 60 days after treatment.;The cure rate of BV after 7 days of treatment;The time from the completion of treatment to the first recurrence of BV.; | — |
Countries
China
Contacts
Public ContactZhang Dai
Peking University First Hospital
Outcome results
None listed