Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome: a Randomized, Parallel Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Improvement in menstrual cycle
研究概览
简要总结
The purpose of this clinical trial is to evaluate the safety and effectiveness on the clinical and biological parameters of reproductive-aged PCOS women after a 12-week metformin and/or probiotics administration.
详细描述
Probiotics are live bacteria that offer a health benefit to the host when administered in adequate amounts. Probiotic supplementation is safe for use and has demonstrated beneficial effects for metabolic diseases such as obesity and diabetes. In this study, about 90 reproductive-aged women with PCOS will be enrolled. Participants will be randomly assigned into one of the following three groups: Metformin tablets (0.5g tid po), ProMetS probiotics powder (4g qN po), Metformin tablets (0.5g tid po) and ProMetS probiotics powder (4g qN po), for 12 weeks. Blood and stool samples will be collected before and after treatment. Fasting glucose levels, fasting insulin levels, sex hormone levels, serum lipid profiles, inflammation markers, other metabolic related parameters and change of gut microbiota and immune cells 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal between 18-40 years of age.
- •Diagnosed PCOS defined as 2003 Rotterdam diagnostic criteria.
排除标准
- •During the pregnancy and lactation period.
- •Significant impaired liver function, impaired renal function, mental disease, severe infection, severe anemia, severe heart disease and neutropenia disease.
- •Use of antibiotics within 3 months.
- •Symptoms of any infection at screening.
- •Immunodeficient or use of immunosuppressive drugs.
- •Use of products containing prebiotics or probiotics within the last 3 months.
- •Previous history of gastrointestinal surgery or disease (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
Metformin
干预措施: Metformin tablets (Drug)
Probiotics
干预措施: ProMetS probiotics powder (Drug)
Metformin and Probiotics
干预措施: 1. Metformin tablets; 2. ProMetS probiotics powder (Drug)
结局指标
主要结局
Improvement in menstrual cycle
时间窗: 12 weeks
Patients will be required to maintain a menstrual calendar and record their basal body temperature for the duration of the study and asked to fill a questionnaire before and after study. The questionnaire will cover menstrual cycle dates, duration and amount.
Improvement in hirsutism
时间窗: 12 weeks
Modified Ferriman and Gallwey score (m-FG scores) will be measured before and after study. M-FG score \> 8 is considered hirsutism and when the score is higher, the symptom is more serious.
Improvement in acne score
时间窗: 12 weeks
Visual assessment of acne using "mild/moderate/severe" grades will be assessed before and after study.
次要结局
- Fasting glucose levels(12 weeks)
- Fasting insulin levels(12 weeks)
- Gut microbiota(12 weeks)
- Serum lipid profiles(12 weeks)
- Inflammation markers(12 weeks)
- Serum testosterone levels(12 weeks)
- Immune cells(12 weeks)
- Serum follicle-stimulating hormone levels(12 weeks)
- Serum luteinizing hormone levels(12 weeks)
- Serum estradiol levels(12 weeks)
研究者
Dalong Zhu
Chief Physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School