FAECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF MORBID OBESITY
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Reduction of weight
研究概览
简要总结
40 patients meeting the criteria for obesity surgery are enrolled. Fecal microbiota transplantation (FMT) will be administered in gastroscopy 6 months before obesity surgery. 20 of the patients will receive a fecal transplant of a thin donor and 20 will receive placebo - a transplant made of their on feces. Changes in weight, laboratory values, general well being and stool microbiota will be measured up to one year after the surgery; one and a half years after FMT. The hypothesis is that FMT and the change in gut microbiota will help to reduce and maintain lower weight.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for the bariatric surgery
- •BMI ≥ 40 or BMI ≥35 and at least two obesity-related co-morbidities such as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease.
- •Availability of consecutive fecal samples during one year
- •Compliance to attend gastroscopy and FMT
- •18-65 years
排除标准
- •Unable to provide informed consent
- •Pregnancy
- •Type I Diabetes Mellitus
- •Severe renal insufficiency, GFR<30%
- •Chronic or recurrent bacterial infection needing antimicrobial treatment
- •Large hiatal hernia
研究组 & 干预措施
Intervention arm
Fecal transplant from a thin donor
干预措施: Fecal microbiota transplantation (Other)
Placebo arm
Fecal transplant made from patients own feces
干预措施: Fecal microbiota transplantation (Other)
结局指标
主要结局
Reduction of weight
时间窗: 1,5 years
次要结局
未报告次要终点