BV?HPV
Conditions
Interventions
Part I: BH group (patients with BV and HPV):None
Part I: C group (healthy females):None
Part II: BHO group (conventional treatment):Matrine gel (used strictly according to clinical guidelines) + interferon vaginal suppositories (used strictly according to clinical guidelines)
Part II: BHLC group (probiotic intervention):Matrine gel (used strictly according to clinical guidelines) + probiotic capsules vaginal administration (once daily, for three months)
Sponsors
The Ninth Hospital of Nanchang
Eligibility
Sex/Gender
Female
Age
20 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Females aged 20–55 years; 2. Diagnosed with BV via vaginal smear, Nugent score, etc., with HPV DNA testing confirming HPV infection (including high-risk and/or low-risk types); 3. No use of antibiotics, antifungal agents, or vaginal topical medications within the preceding 2 months; 4. No HPV-related antiviral or immunomodulatory treatment within the preceding 4 months; 5. Absence of immunological disorders, diabetes mellitus, or other metabolic diseases; 6. Agreement during the trial period to refrain from using other vaginal antibacterial/antibiotic products, oral antibiotics, or probiotic-containing medications/supplements, and to not participate in other clinical studies; 7. Understanding of the study content, compliance with trial requirements, and signing of the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects who have taken oral contraceptives, antibiotics, immunosuppressants, or other medications within the past three months; 2. Patients with a history of high-grade cervical intraepithelial neoplasia (CIN), cervical cancer, or genital tract tumors; those who have undergone hysterectomy; or those with a known allergy to the study drug(s) or probiotics; 3. Patients suffering from acute urogenital infections, such as pelvic inflammatory disease (PID), acute cervicitis, or urinary tract infections requiring intervention; 4. Patients diagnosed with uterine fibroids, endometrial hyperplasia, endometriosis, or adenomyosis; 5. Patients infected with Human Immunodeficiency Virus (HIV) or syphilis; 6. Patients with active infections of gonorrhea, chlamydia, or trichomoniasis; 7. Pregnant or lactating women, postmenopausal women, or individuals with immunocompromised states (such as diabetes mellitus or immunodeficiency disorders).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of bacterial vaginosis symptoms (e.g., abnormal vaginal discharge, vulvar pruritus, odor);HPV clearance rate;Change in HPV viral load;Cervical local immune status (distribution of immune cell subpopulations);Cervical local immune status (secretion levels of immune-related cytokines);Vaginal microbiota diversity, dominant microbial species and abundance, and pH value;Recurrence rate of bacterial vaginosis;Dynamic changes in HPV infection status; | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in vaginal microecological metabolic profile;Improvement in TCT findings (improvement rate of cervical cytological abnormalities and inflammation);Improvement rate of pathogenic bacterial infections (e.g., BV, AV) by Gram staining; | — |
Countries
China
Contacts
Public ContactHe Xia
The Ninth Hospital of Nanchang
Outcome results
None listed