Exploratory Clinical Study on the Efficacy and Safety of Lactobacillus Johnsonii in the Treatment of Patients with Premature Ovarian Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Ovarian function markers
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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;
- •Not having participated in other clinical trials within the past 3 months.
排除标准
- •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;
- •Stage IV endometriosis;
- •Uncontrolled endocrine diseases or autoimmune diseases;
- •Organic gastrointestinal diseases;
- •Infectious diseases of the reproductive, urinary, or digestive systems;
- •Severe cardiovascular, respiratory, renal, hematologic, endocrine, neurological, psychiatric, or other systemic diseases that the investigator believes may interfere with the study evaluation;
- •History of venous thromboembolism;
- •Allergic or intolerant to the components of the investigational probiotic product;
- •Allergic to two or more types of food/medications;
- •Refusal to provide written informed consent;
- •Other conditions deemed unsuitable for participation in the study by the investigator.
结局指标
主要结局
Ovarian function markers
时间窗: 6 months
Changes in sex hormone levels (including follicle-stimulating hormone, luteinizing hormone, estradiol, progesterone, testosterone, prolactin and anti-Müllerian hormone) and menstruation resumption.
次要结局
- Changes in antral follicle counts(6 months)
- Changes in perimenopausal symptom(6 months)
- Changes in mental and psychological status(6 months)
- Achievement of pregnancy(8 months)
- Changes in the gut microbiota.(6 months)