NCT04579263已完成不适用
Assessment of Improvement in Glycemic Control, Weight, and Insulin Sensitivity in Obese Patients After Fecal Microbiota Transplantation (FMT) Against the Background of Glucose-lowering Therapy
Federal Research and Clinical Center of Physical-Chemical Medicine4 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2020年2月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Change in insulin sensitivity within FMT, 6 months after FMT]
研究概览
简要总结
Search for mechanisms of the effect of fecal microbiota transplantation on patients with obesity
详细描述
- To select recipients of fecal samples according to eligibility criteria;
- To perform fecal microbiota transplantation for patients with obesity;
- To analyze the efficacy of fecal microbiota transplantation for patients with obesity within six months after therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age of patients - from 18 to 75 years, both sexes;
- •patients with obesity (body mass index ≥40
- •patient's informed consent to perform fecal microbiota transplantation
排除标准
- •presence of a concomitant chronic infectious disease or malignancy
- •patients with a proven allergy to foods not excluded from the donor's diet
- •absence of the patient for one or more intermediate stages of the examination.
- •informed refusal to continue therapy
结局指标
主要结局
Change in insulin sensitivity within FMT, 6 months after FMT]
时间窗: 6 months after FMT
participants will undergo euglycaemic glucose clamp study
次要结局
未报告次要终点
研究者
研究点 (4)
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