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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus johnsonii | Experimental | Participants receive Lactobacillus johnsonii |
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| Placebo | Placebo Comparator | Participants receive placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus johnsonii | Dietary Supplement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in antral follicle counts | 6 months | |
| Changes in perimenopausal symptom | MENQOL Score (Menopause-Specific Quality of Life Questionnaire) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liangjing Wang | Contact | 86-13777848083 | wangljzju@zju.edu.cn |
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| Placebo | Other | 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. |
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| Changes in mental and psychological status | DASS-21 Scale (Depression, Anxiety, and Stress Scale-21) | 6 months |
| Achievement of pregnancy | Pregnancy outcomes achieved through natural or assisted conception methods include biochemical pregnancy, clinical pregnancy, miscarriage, and ectopic pregnancy. | 8 months |
| Changes in the gut microbiota. | 6 months |
| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C444423 | CbsT2 protein, Lactobacillus johnsonii |
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