Effect of Metformin and Probiotics on Gut Microbiome in Healthy Subjects: a Randomized, Double-blind Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Gut microbiota alterations
研究概览
简要总结
This clinical trial is designed to evaluate the alteration of gut microbiome in healthy subjects after a 12-week metformin and/or probiotics administration.
详细描述
Gut microbiome dysbiosis have been linked with the onset and progression of several diseases. Metformin and probiotics have been confirmed to function partly by regulating the gut microbiome. The investigators are now wondering if metformin/probiotics treatment will change the gut microbiota in healthy subjects and show some benefits.
In this study, about 60 healthy subjects will be enrolled. Participants will be randomly assigned into one of the following three groups: Metformin powder (0.5g tid po), Probiotics powder (0.5g tid po), Placebo powder (0.5g tid po), for 12 weeks.
Blood and stool samples will be collected before and after treatment. Fasting glucose levels, fasting insulin levels, serum lipid profiles, inflammation markers and alteration of gut microbiota will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 20-60 years of age.
- •Healthy subjects without known diseases.
排除标准
- •During pregnancy and lactation period.
- •Impaired liver function, impaired renal function, mental disease, severe infection, severe anemia, severe heart disease and neutropenia disease.
- •Use of metformin/antibiotics within 3 months.
- •Immunodeficient or use of immunosuppressive drugs.
- •Previous history of gastrointestinal surgery or diseases (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder).
- •Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator.
研究组 & 干预措施
Drug: Metformin powder
0.5g of Metformin powder administered three times a day orally before meal
干预措施: Metformin powder (Drug)
Drug: Probiotics powder
0.5g of Probiotics powder administered three times a day orally before meal
干预措施: Probiotics powder (Drug)
Drug: Placebo powder
0.5g of Placebo powder administered three times a day orally before meal
干预措施: Placebo powder (Other)
结局指标
主要结局
Gut microbiota alterations
时间窗: 12 weeks
Gut microbiota composition and function will be assessed before and after study.
次要结局
未报告次要终点
研究者
Mingming Zhang
Physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School