The goal of this clinical trial is to explore the effectiveness and safety of Lactobacillus johnsonii in improving ovarian function and perimenopausal symptoms in patients with premature ovarian insufficiency (POI). The main questions it aims to answer are: ① To explore the effectiveness and safety of Lactobacillus johnsonii in improving ovarian function and perimenopausal symptoms in patients with POI; ② To explore the potential mechanism of action of Lactobacillus johnsonii in improving ovarian function and perimenopausal symptoms in patients with POI. Participants who meet all the inclusion criteria will be enrolled in the study and randomly assigned in a 1:1 ratio to either the Lactobacillus johnsonii group or the placebo group.
Age between 20 and 39 years;
Irregular menstruation or amenorrhea for > 4 months;
At least two serum baseline follicle-stimulating hormone (FSH) levels > 25 IU/L (with an interval of more than 4 weeks between measurements);
Willing to voluntarily participate in this study, sign the informed consent form, and comply with the investigation and follow-up;
Use of antibiotics or probiotics, prebiotics, and live bacterial preparations within the past month or during the intervention period;
Received hormone replacement therapy within the past 2 months;
Chromosomal abnormalities and genetic defects;
Iatrogenic premature ovarian insufficiency;
Parallel
Lactobacillus johnsonii
Dietary supplementThe investigational product is a probiotic containing Lactobacillus johnsonii. It is recommended to be stored under refrigerated conditions at approximately 4°C. Participants are instructed to take one sachet twice daily, dissolved in warm water, with a total daily oral dose exceeding 1×10¹¹ colony-forming units (CFU).
Placebo
Other interventionThe placebo product contains the same excipients as the investigational product, except for the absence of Lactobacillus johnsonii. It is identical to the investigational product in appearance, color, weight, and taste. It is recommended to be stored under refrigerated conditions at approximately 4°C. The administration method is the same as that of the experimental group.
Ovarian function markers
Changes in sex hormone levels (including follicle-stimulating hormone, luteinizing hormone, estradiol, progesterone, testosterone, prolactin and anti-Müllerian hormone) and menstruation resumption.
Changes in antral follicle counts
Changes in perimenopausal symptom
MENQOL Score (Menopause-Specific Quality of Life Questionnaire)
Changes in mental and psychological status
DASS-21 Scale (Depression, Anxiety, and Stress Scale-21)
Achievement of pregnancy
Pregnancy outcomes achieved through natural or assisted conception methods include biochemical pregnancy, clinical pregnancy, miscarriage, and ectopic pregnancy.
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