Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- difference in euglycemic clamp value at baseline and after the treatment
研究概览
简要总结
Obesity is associated with changes in the composition and metabolic function of the gut microbiota. Fecal microbiota transplantation (FMT), also known as "fecal bacteriotherapy" or "fecal infusion", refers to the process of injecting a liquid suspension of stool from a healthy donor into the gastrointestinal (GI) tract of a patient to cure a specific disease. However, since the recently established concept of human gut microbiome and its significant role in health and disease has caught on in the medical scientific world, this procedure has gained a great pathophysiological strength, meaning not only the simple infusion of stools, but the transplantation of a healthy gut microbiota in a patient with a disrupted one. In a recent dutch experience, FMT from lean donors was able to increase the insulin sensitivity in patients with metabolic syndrome.
Our primary aim is to evaluate if FMT from lean healthy donors, in association to lifestyle changes, is able to reduce insulin-resistance more than lifestyle changes alone in patients with metabolic syndrome.
All the patients with metabolic syndrome will receive lifestyle counselling (1400 kilocalories diet and physical activity encouragement), than will be randomized to FMT from healthy lean donors by upper endoscopy (group A) or no treatment (group B)
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both males and females between 30 and 60 years old
- •BMI>30 and >35 kg/m2
- •Diagnosis of Metabolic Syndrome according to National Cholesterol Education Program's Adult Treatment Panel III criteria
- •No ongoing therapy for diabetes, hyperlipidemia or arterial hypertension
- •Signature of written informed consent
排除标准
- •recent (3 months) use of probiotic, antibiotics or other drugs
- •Increase in triglycerides levels, (≥ 300 mg/dl), LDL levels (≥ 190 mg/dl, or modification of body weight (±5%) during the last 3 months
- •Relevant cardiovascular diseases or kidney diseases
- •Relevant gastrointestinal diseases (such as inflammatory bowel disease or celiac disease)
- •Former gastrointestinal surgery
结局指标
主要结局
difference in euglycemic clamp value at baseline and after the treatment
时间窗: 6 months
次要结局
- Modification in blood pressure(6 months)
- Modification in fasting blood glucose(6 months)
- Modification in serum interleukin-6(6 months)
- Modification in serum Tumor Necrosis Factor-alpha(6 months)
- Modification in serum High Density Lipoprotein cholesterol(6 months)
- Disappearance of metabolic syndrome(6 months)
- Modification in serum triglycerides(6 months)
- Modification in abdominal circumference(6 months)
- Modification in serum C-Reactive Protein(6 months)
- Modification in flow-mediated dilatation (FMD) of the brachial artery(6 months)
研究者
Giovanni Cammarota
Prof
Catholic University of the Sacred Heart