Intestinal Probiotics Dietary Supplement
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- gonadal hormone concentrations
研究概览
简要总结
In order to study the community profile of the intestinal microbiome in women with ovarian dysfunction, as well as the relationship between the changes in the intestinal microbiota and sex hormones, this study recruited 30 women with ovarian dysfunction and 30 healthy women. Sequencing was performed on the V3-V4 region of the 16S rDNA gene in fecal samples, and blood serum of the patients was collected for the study of changes in the systemic metabolome to reveal the significant differences in the intestinal microbiota between the subjects with ovarian dysfunction and the control group, as well as the related metabolic pathways.
详细描述
At the same time, in order to evaluate the effectiveness, safety and tolerance of supplementing the Akk. muciniphila bacteria, as well as to explore the impact of supplementing Akk. muciniphila bacteria on human ovarian function, this study aims to be the first clinical research to explore the effect of supplementing Akk. muciniphila bacteria on human ovarian function.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •1. Ovarian dysfunction
- •Age < 40 years old; ② Irregular menstruation or amenorrhea for ≥ 4 months; ③ Two abnormal FSH levels (POF: FSH > 40 U/L; POI: FSH > 25 U/L);
- •Agree to participate in the study and be able to provide biological samples as required;
- •Body mass index within the normal range (18.5 kg/m² ≤ BMI < 24 kg/m²);
- •Strict contraception during treatment;
- •Control group:
- •Women have normal ovarian function;
- •No history of menstrual irregularity and infertility;
- •Regular menstruation;
- •Normal FSH levels (< 10 IU/L);
- •Age (< 40 years old) and body mass index (within the normal range 18.5 kg/m² ≤ BMI < 24 kg/m²) are matched with the case group; (The matching settings for the case group and the control group have been completed);
排除标准
- •1. Difficult to cooperate with researchers;
- •Those with congenital reproductive system disorders;
- •Those with chromosomal disorders;
- •Those with other systemic diseases;
- •Those with a history of ovarian surgery resection;
- •Chemotherapy/radiotherapy treatment;
- •Patients who have used antibiotics, antifungal drugs, antiviral drugs, proton pump inhibitors, corticosteroids or oral contraceptives within 3 months;
- •Patients who have been taking large doses of probiotic preparations for a long time.
结局指标
主要结局
gonadal hormone concentrations
时间窗: After taking the medicine for three months
Number of antral follicles
时间窗: After taking the medicine for three months
次要结局
未报告次要终点
研究者
Songling Zhang
Doctor
The First Hospital of Jilin University