Breast cancer
Conditions
Interventions
Vaginal Microbiota Transplantation Group (VMT Group):Participants will receive a vaginal microbiota preparation containing two Lactobacillus strains (VB247 and VB250). The dose is 10^8CFU per adminis
Control Group:Participants in the control group will receive a placebo preparation identical in appearance, odor, texture, and packaging to the intervention product but without active Lactobacillus (o
Sponsors
Women's Hospital School of Medicine Zhejiang University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Demographic characteristics: (1) Women aged 18-45; (2) Previously regular menstruation, confirmed premenopausal status. 2. Disease characteristics: (1) Pathologically confirmed invasive breast cancer; (2) Immunohistochemistry confirms hormone receptor positivity (ER and/or PR); (3) Currently receiving OFS AI therapy for >=6 months; (4) GSM-related symptoms (vaginal dryness, dyspareunia, vulvar itching, urinary irritation, etc.) persisting for >=3 months. 3. Laboratory criteria: (1) Nugent score >=4; (2) Vaginal pH >4.5; (3) qPCR detection of Lactobacillus concentration <10^4 CFU/ml.
Exclusion criteria
Exclusion criteria: 1. Presence of a definitely diagnosed active vaginal infection, including any of the following, at the screening visit: (1) Bacterial vaginosis (BV): At least three clinical diagnoses meet Amsel criteria, or a Nugent score of 7-10 for vaginal discharge. (2) Vulvovaginal candidiasis (VVC): with typical clinical symptoms, and vaginal secretions are found to be pseudohyphae or spores of Candida or positive fungal culture. (3) Trichomoniasis vaginitis: Vaginal secretions wet film microscopic examination found Trichomonas vaginalisis, or positive pathogen nucleic acid test. (4) Aerobic vaginitis (AV): According to the Donders standard, the comprehensive score based on wet film microscopy of vaginal secretions >=3 points. 2. Have a severe immunodeficiency disease, including but not limited to: (1) Human immunodeficiency virus (HIV) infected. (2) Patients who are receiving high-dose, systemic immunosuppressive therapy (defined as: continuous use of prednisone>=20mg/day or equivalent dose of other immunosuppressants for more than 2 weeks within 4 weeks prior to study screening). (3) Other known primary or secondary immunodeficiency diseases. 3. Received systemic (oral or intravenous) antibiotic therapy for any reason within 1 month prior to the start of study intervention. 4. Current use of systemic hormone therapy that may significantly affect the vaginal microbiome, including estrogen, progestogen, or glucocorticoids in oral, injectable, or patch form. Note: For patients on long-term (>3 months) and stable use of low-dose topical estrogen (e.g., estriol cream) for the treatment of urogenital atrophy, it is not an exclusion criterion if the dose remains unchanged during the study, but it needs to be documented in detail in the case report form. 5. Known or suspected history of allergy to any active ingredient (such as Lactobacillus) or excipients (such as milk product ingredients) in the investigational product. 6. Participated in any other interventional clinical study within 3 months before screening. 7. Subject has any medical, psychological, or social condition that may affect his completion of the study, or poor compliance, according to the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaginal microbiome restoration rate 3 months after treatment;Incidence of intervention-related adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Female Sexual Function Index (FSFI) score;Change in Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT?ES) score;Change in Vaginal Health Index (VHI) score;Persistence of vaginal microbiota restoration; | — |
Countries
China
Contacts
Public ContactFang Wan
Women's Hospital School of Medicine Zhejiang University
Outcome results
None listed