Malabsorption and Gut Microbiota Profile Changes After Laparoscopic Mini-Gastric Bypass (MGB) vs Roux-en-Y Gastric Bypass (RYGB): a Prospective Multicenter Comparative 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
- 2
- 主要终点
- Gut Microbiota
研究概览
简要总结
Bariatric surgery represents the best therapeutic option to induce sustainable weight loss and to solve serious comorbidities improving the life-expectancy and the quality of life. Actually the choice of the procedure is based on the surgeon's and patients preference . Mini gastric bypass(MGB) is an emerging procedure offering excellent results in terms of weight loss and comorbidities (mainly metabolic) control. On the other hand, recent data indicated that the gut microbiota may mediate some of the beneficial effects of bariatric surgery and changes in the composition and diversity of the gut microbiota have been observed after RY Gastric Bypass (RYGB) in humans as well as in mice. However, there are no prospective investigations on Gut Microbiota changes after MGB, despite the procedure is described as "malabsorptive" and there are no studies comparing gut microbiota shift and malabsorption entity in humans after RYGB vs MGB. Thereafter prospective data on the incidence of bile reflux esophageal lesions after MGB are lacking.
The aim of the present multicentric prospective comparative study is to evaluate malabsorption and gut microbiota shift after laparoscopic RYGB vs MGB at 1 year.
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
- None
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
- 是
入选标准
- •BMI 40-55 kg/m2
- •Non smokers
- •Primary Mini Gastric Bypass or Roux en Y Gastric Bypass without any concomitant surgeries except hiatal hernia repair
- •Enrollment in the two study groups will be on the basis of patient choice.
排除标准
- •Different bowel measurement (plus or minus 10%).
- •Conversion to open surgery, reoperation
- •Helicobacter Pylori positive previous or current
- •Free PPI 4 weeks before 6th month (after surgery)
- •Corticosteroids, vitamine E, fish oil treatment 2 months before surgery
- •Anti or pre- biotics treatment 2 months before surgery
- •Chronic gastrointestinal diseases or syndromes
- •Previous bariatric surgery (intragastric balloon excluded)
- •Previous resective bowel surgery
- •Previous pancreatic surgery
- •Previous Hepato BilioPancreatic surgery
- •Gallbladder gallstones
结局指标
主要结局
Gut Microbiota
时间窗: 0-6-12 Months
To evaluate and compare Roux en Y Gastric Bypass vs Mini Gastric Bypass microbiota profile shift 1 year after surgery and its impact on metabolic and nutritional status after surgery.
次要结局
- Glucagon - like peptide 1 (GLP-1)(0-12 Months)
研究者
Gianfranco Silecchia
MD PhD Prof. G. Silecchia
University of Roma La Sapienza