Perimenopausal Syndrome
Conditions
Interventions
Control Group:placebo
Sponsors
Nanchang Reproductive Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Female participants aged 18–55 years (inclusive of boundary values); 2. Have experienced irregular menstrual cycles within the past year, or have had natural amenorrhea for no more than 12 months; 3. For natural perimenopausal female patients, serum baseline follicle-stimulating hormone (FSH) > 10 IU/L; 4. Modified KMI score >= 15; 5. Willing and able to comply with the study visit schedule and other requirements of the study protocol.
Exclusion criteria
Exclusion criteria: 1. Study participants who have received any of the following treatments prior to the first dose: a. Within 1 month before the first dose, consumption of any dietary supplements containing active probiotics, prebiotics, or postbiotics, or intake of health foods with phytoestrogenic effects (e.g., soy isoflavone extracts, red clover, etc.) and black cohosh; b. Within 1 month before the first dose, receipt of systemic antibiotic therapy; c. Within 3 months before the first dose, receipt of any form of hormone replacement therapy (HRT); d. Within 1 month before the first dose, use of traditional Chinese medicines or patented Chinese patent medicines whose labels or prescriptions explicitly indicate treatment for perimenopausal syndrome. 2. Presence of clinically significant disorders of the cardiovascular, respiratory, digestive, endocrine, hematopoietic, or nervous systems, or psychiatric disorders, or any other serious and/or unstable disease or history thereof, which, in the investigator's opinion, would pose a safety risk to participation in this study; 3. Clinical evaluation by the research staff suggests a risk of malignancy; 4. History of malignant tumors; 5. Persistent intermenstrual bleeding or heavy uterine bleeding resembling collapse; 6. Allergy to probiotic excipients; 7. Pregnant or breastfeeding women; 8. Other conditions that, in the investigator's opinion, make the participant unsuitable for enrollment in the trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified KMI;Gut microbiota; | — |
Countries
China
Contacts
Public ContactWeijun Chen
Nanchang Reproductive Hospital
Outcome results
None listed