Bacterial Vaginosis
Conditions
Interventions
Treatment Group:Live quadruple lactobacillus capsules
Control Group:Live quadruple lactobacillus capsules placebo
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 55 years (inclusive), females of childbearing potential with sexual history; 2.Have a regular menstrual cycle as assessed by the investigator, and be able to administer the investigational product as required by the protocol; 3.Subjects with a clinical diagnosis of Bacterial Vaginosis (BV) at the screening visit: meeting at least 3 positive items of the Amsel clinical criteria (a positive result for clue cells is a mandatory requirement) with a Nugent score of >= 7 points; being newly treated or recurrent BV cases (i.e., first-ever diagnosis of BV, or new-onset BV with a prior history of BV). Diagnostic results issued by the study hospital within 3 days before the signing of the informed consent form are acceptable; 4.After the metronidazole lead-in period (i.e., baseline period), subjects are clinically diagnosed with cured BV [defined as at least 2 negative items in the Amsel clinical criteria (negative clue cells are a mandatory requirement) and a Nugent score < 7 points]; 5.Participants are willing to have no pregnancy plan from screening through study drug administration and within 3 months after drug discontinuation, and agree to adopt effective contraceptive measures (abstinence from sexual intercourse or consistent barrier contraception with condoms); 6.The participant is able to understand and comply with the procedures and requirements of this study, and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects with known current acute genitourinary tract infections, including pelvic inflammatory disease, acute cervicitis, and urinary tract infection requiring intervention; 2.Subjects with vulvovaginal candidiasis (VVC), trichomoniasis vaginalis, suspected gonorrhea, confirmed gonorrhea, herpes simplex virus infection and/or condyloma acuminata (CA) at screening; 3.Patients with other vaginal or vulvar conditions that may confound the interpretation of clinical response; 4.Subjects with unexplained vaginal bleeding, or known uterine leiomyoma, endometrial hyperplasia or adenomyosis that require interventional treatment as judged by the investigator; 5.Subjects who have received local or systemic antimicrobial therapy within 7 days prior to screening, and/or are expected to receive such treatment during the trial period (excluding metronidazole and fluconazole); 6.Subjects with a history of malignancy prior to screening who are deemed ineligible for enrollment by the investigator; 7.Subjects with a history of major gynecological surgery within 6 months prior to screening (with deep wounds and prolonged recovery period); or those with a history of superficial gynecological surgery or routine gynecological procedures within 60 days prior to screening (including but not limited to Bartholin’s cyst incision, Bartholin’s abscess incision, intrauterine device insertion/removal, cervical or vaginal wall biopsy, cervical conization or loop electrosurgical excision procedure [LEEP]); or those within 60 days since the last pregnancy termination at screening; 8.Subjects with obvious vaginal mucosal lesions indicated by gynecological examination at screening (e.g., mucosal edema, congestion, and ulceration); 9.Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN), serum creatinine (Cr) > 1.5 times ULN, and urea / blood urea nitrogen (BUN) > 1.5 times ULN at screening; 10.As assessed by the investigator, subjects with any concomitant diseases, prior surgeries, concurrent medications, or clinically significant abnormal laboratory findings that may interfere with the evaluation of the investigational product; 11.Known allergy to similar drugs (e.g., live lactobacillus capsules for vaginal use), or hypersensitivity to metronidazole or fluconazole; 12.Pregnant or breastfeeding female subjects; 13.Subjects who have participated in any interventional clinical study within 30 days prior to the first study drug administration of this trial, or who are enrolled in or plan to participate in any other interventional study during the present trial; 14.Any other medical conditions deemed by the investigator to potentially affect the interpretation of trial results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BV cumulative recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs, physical examination, laboratory tests (blood routine, blood biochemistry, urine routine), gynecological examination, 12-lead electrocardiogram (ECG), adverse events, etc.;BV recurrence rate;Time to first BV recurrence; | — |
Countries
China
Contacts
Public ContactLan Zhu
Peking Union Medical College Hospital
Outcome results
None listed