Premature Ovarian Insufficiency
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus johnsonii
The 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).
OTHERPlacebo
The 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.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 20 and 39 years; 2. Irregular menstruation or amenorrhea for \> 4 months; 3. At least two serum baseline follicle-stimulating hormone (FSH) levels \> 25 IU/L (with an interval of more than 4 weeks between measurements); 4. Willing to voluntarily participate in this study, sign the informed consent form, and comply with the investigation and follow-up; 5. Not having participated in other clinical trials within the past 3 months.
Exclusion criteria
1. Use of antibiotics or probiotics, prebiotics, and live bacterial preparations within the past month or during the intervention period; 2. Received hormone replacement therapy within the past 2 months; 3. Chromosomal abnormalities and genetic defects; 4. Iatrogenic premature ovarian insufficiency; 5. Stage IV endometriosis; 6. Uncontrolled endocrine diseases or autoimmune diseases; 7. Organic gastrointestinal diseases; 8. Infectious diseases of the reproductive, urinary, or digestive systems; 9. Severe cardiovascular, respiratory, renal, hematologic, endocrine, neurological, psychiatric, or other systemic diseases that the investigator believes may interfere with the study evaluation; 10. History of venous thromboembolism; 11. Allergic or intolerant to the components of the investigational probiotic product; 12. Allergic to two or more types of food/medications; 13. Refusal to provide written informed consent; 14. Other conditions deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovarian function markers | 6 months | Changes in sex hormone levels (including follicle-stimulating hormone, luteinizing hormone, estradiol, progesterone, testosterone, prolactin and anti-Müllerian hormone) and menstruation resumption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in antral follicle counts | 6 months | — |
| Changes in perimenopausal symptom | 6 months | MENQOL Score (Menopause-Specific Quality of Life Questionnaire) |
| Changes in mental and psychological status | 6 months | DASS-21 Scale (Depression, Anxiety, and Stress Scale-21) |
| Achievement of pregnancy | 8 months | Pregnancy outcomes achieved through natural or assisted conception methods include biochemical pregnancy, clinical pregnancy, miscarriage, and ectopic pregnancy. |
| Changes in the gut microbiota. | 6 months | — |
Contacts
Primary ContactLiangjing Wang
Outcome results
None listed