Probiotics for Gallstones in Post-bariatric Surgery Patients:A Prospective
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Gallstones formation
研究概览
简要总结
Morbid obesity has become a major global health problem, and the use of bariatric surgery is increasing. One common complication seen following bariatric surgery is the formation of gallstones. Contributing factors to gallstone formation include hypomotility of gall bladder and supersaturation of bile due to rapid weight loss and mobilization of cholesterol. Previous studies revealed oral probiotics could reduce the cholesterol level by as much as 22% to 33%. The possible mechanisms included bile salt hydrolase activity, assimilation of cholesterol by the bacteria, binding of cholesterol to the bacterial cell wall and physiological actions of the end products of short chain fatty acid fermentation. Therefore, the aim of this study was to determine the ability of probiotics to prevent gallstones formation after bariatric surgery and to evaluate the impact of oral administration of probiotics on the post bariatric surgery patients 's quality of life.
Gastrointestinal Quality of Life Index is a widely accepted questionnaire for evaluating the quality of life for patients receiving bariatric surgery. It consists of five domains: digestive symptoms; physical function; emotional condition; social condition and effect of medical treatment, which could access the quality of life of bariatric patient effectively and completely.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving bariatric surgery for morbid obesity
- •Patiets at ages between 20 to 65 y/o
- •Patients willing to follow up regulary after bariatric surgery.
排除标准
- •Patients having gallstones before bariatric surgery
- •Patients refusing taking probiotics or refusing regular follow up after bariatric surgery
研究组 & 干预措施
Probiotics group
Miyarisan-BM (Clostridium Butyricum Miyairi) 40 mg po tid x 6 months
干预措施: Miyarisan-BM (Clostridium Butyricum Miyairi) (Drug)
Urso group
ursodoxycholic acid, 200mg po tid x 6 months
干预措施: Urso group (Drug)
Biotase group
Biotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months
干预措施: Biotase group (Drug)
结局指标
主要结局
Gallstones formation
时间窗: 6 months
次要结局
- serum total cholesterol and LDL level(6 months)
