Bacterial vaginosis
Conditions
Interventions
Experimental group A :Live quadruple Lactobacillus capsules for vaginal use
Control groupA:Live quadruple Lactobacillus capsules simulant for vaginal use
Experimental group B :Live quadruple Lactobacillus capsules for vaginal use
Control groupB:Live quadruple Lactobacillus capsules simulant for vaginal use
Sponsors
West China Second University Hospital of Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Subjects fully understand the purpose, nature, method and possible adverse reactions of the study, voluntarily participate in the study, and sign the informed consent before the study begins; 2. Healthy reproductive age women aged 18 to 45 years(including the critical value); 3. Body mass index (BMI) = body weight (kg)/ height^2(m^2),BMI higher than 18.0 and lower than 30.0(including the critical value), subject weight higher than 45.0 kg; 4. Sexual life history,and willing to use vaginal medication,avoid using another vaginal products (such as contraceptive cream, gel, foam, sponge, lubricant, lavage fluid, tampons, etc.) throughout the study period; 5. Not to use antimicrobial drugs or microbiological drugs without permission during the study; 6. Take effective contraceptive measures during the trial (non-sexual behavior or barrier contraception using condoms throughout the trial); 7. No birth plan within 3 months after the end of the study, and voluntarily take effective contraceptive measures during this period; 8. Good communication with the researchers, comprehend and abide by the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Allergic to any ingredient in this product and accessories; Or people with allergies (such as those allergic to two or more drugs or food); 2. Diseases or factors with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, kidney, liver, gastrointestinal system, respiratory system, metabolic system, skeletal system, etc.; There are factors that will endanger the safety of the subject; Or other factors that may affect the medication, such as genital deformities; 3. A history of genital herpes infection, a history of more than two vaginal infections within 6 months prior to administration, or a urogenital infection within 21 days prior to administration (including but not limited to urinary tract infection, bacterial vaginosis, trichomonas vaginalis infection); 4. Patients who had undergone surgical vaginal procedures, pelvic or cervix-related surgical treatment or gynecological examination results showing obvious vaginal wall injury within 3 months before administration; 5. Patients who had undergone major surgery within 30 days prior to administration, or who were scheduled to have surgery during the trial; 6. A history of drug abuse or use of any drug within 6 months before administration; 7. Blood donation or massive blood loss (>=400ml) within 3 months before administration, receiving blood transfusion or using blood products; Or plan to donate blood or blood components during the trial; 8. Pregnancy or lactation. 9. Subjects' sexual behavior without effective and appropriate contraceptive measures within 30 days before administration; 10. Subjects have an egg donation plan within 3 months after the initial medication and the end of the study; 11. Use of any prescription drugs or nonprescription drugs within 14 days before administration; 12. Have received any vaccine within 7 days before administration; 13. Smoke more than 5 cigarettes or use equivalent amount of tobacco products per day in the 30 days before administration; Or cannot guarantee to stop smoking from the date of signing the informed consent to the end of the study; 14. An average of more than 2 units of alcohol intake per day (1 unit =360ml beer with 5% alcohol, or 45ml spirit with 40% alcohol, or 150ml wine with 12% alcohol) during the 30 days prior to administration; Or cannot guarantee to stop drinking alcohol and alcohol products from the time of signing the informed consent to the end of the study; 15. Chronic excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups a day, 1 cup =250ml) within 30 days before administration, or do not agree to stop drinking tea, coffee and/or caffeinated beverages during the study period; 16. People who have special requirements on diet, can't follow the unified diet or have significantly abnormal/special diet (such as diet and low sodium diet) within 30 days before screening; 17. Participated in other drug clinical trials or device clinical trials within 3 months, Use of any other intravaginal medicinal product or medical device; 18. Abnormal vital signs, physical examination or gynecological examination have clinical significance; 19. Laboratory examination (including vaginal discharge, blood routine, blood biochemical, urine routine, the first four items of blood transfusion, pregnancy examination), liquid based thin-layer cytology (cervix and lateral vaginal wall), electrocardiogram examinatio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs;Physical examination;Gynecological examination;Laboratory examination;12 lead electrocardiogram;Adverse events;Liquid based thin-layer cytology; | — |
Secondary
| Measure | Time frame |
|---|---|
| Detection of the vaginal microbiota; | — |
Countries
China
Contacts
Public ContactYu Qin
West China Second University Hospital of Sichuan University
Outcome results
None listed