The Preventive Effect of Probiotics in Pregnant Women With High-risk for Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- the incidence of gestational diabetes
研究概览
简要总结
Gut microbiota is instrumental in the microbial and metabolic network of pregnant women, and is potentially related with gestational diabetes. Perinatal probiotic intervention contributes to improved glucose regulation during pregnancy. Our randomized, double-centered, placebo-controlled study is planned to recruit 334 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly probiotic powder per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about neonatal weight will be registered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
The random number table is compiled by the investigator who is specially responsible for grouping and saved. The investigator packaged and coded drugs according to random number table, and recorded. The packaged and numbered drugs are stored in the enrollment office.
When the participants meet the inclusion criteria by care providers (doctors), the enrollment office generates a random number for each subject. The participants received the package of drugs according to their random number, and the random number was recorded in the record book.
If there are adverse events or the subjects request to withdraw from the trial, the investigator should uncover the blind.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women who meet the high-risk indicators for GDM and agree to participate in this study.
- •included between 12-16 gestational weeks
- •A woman was considered high risk when her pre-pregnancy BMI ≥ 24 kg/m^2, having family history of diabetes (type 1 or 2), GDM or PCOS (polycystic ovary syndrome) history, history of delivering macrosomia or stillbirth, or glucose in urine (+)
排除标准
- •Taking probiotics or prebiotics within the past month
- •Have a history of allergies to the drug components or similar drugs in this study
- •Having long-term smoking or drinking habits
- •Type 1 or type 2 diabetes patients with definite diagnosis before pregnancy
- •Diseases in other important organs such as heart, liver, and kidney
- •with clear digestive system diseases
- •Multiple pregnancy
- •with mental or cognitive impairments who are unable to complete this study
研究组 & 干预措施
Probiotics
Probiotic powder 1 bag per day, as well as health guidance about diet and exercise. From recruitment until OGTT.
干预措施: Probiotics (Dietary Supplement)
Placebo
Placebo 1 bag per day. Similar health guidance about diet and exercise. From recruitment until OGTT
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
the incidence of gestational diabetes
时间窗: 24-28th weeks gestation
The number of cases and incidence of gestational diabetes according to OGTT
次要结局
- The incidence of macrosomia(Delivery)
- Weight gain during pregnancy (kg)(Delivery)