Probiotics for Gallstones in Post-bariatric Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The incidence of gallstones in bariatric surgery patients
研究概览
简要总结
Obesity is an increasing epidemic worldwide and has a significant impact on human health and socioeconomics. Multiple studies have shown that bariatric surgery increases the risk of postoperative gallbladder stones. Contributing factors to gallstone formation include gallbladder motility and bile supersaturation due to rapid weight loss and cholesterol mobilization. At present, the prevention and treatment of gallbladder stones in obese patients after bariatric surgery are still controversial. In recent years, the study of ursodeoxycholic acid in preventing gallbladder stone formation after bariatric surgery has become a research hotspot. At the same time, other studies have shown that taking probiotics or digestive enzymes may improve gastrointestinal symptoms and improve quality of life after bariatric surgery. Therefore, the purpose of this study was to determine the ability of probiotics to prevent gallstone formation after bariatric surgery and to evaluate the impact of oral probiotics on quality of life in patients after bariatric surgery.
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 60 Years(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 60 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
Ursodoxycholic acid group
Ursodoxycholic acid, 250mg po tid x 6 months
干预措施: Ursodoxycholic acid group (Drug)
Bifidobacterium group
Bifidobacteria, 210 mg po tid x 6 months
干预措施: Bifidobacterium group (Drug)
Bifidobacterium and ursodeoxycholic acid group
Ursodoxycholic acid, 250mg po tid x 6 months Bifidobacteria, 210 mg po tid x 6 months
干预措施: Ursodoxycholic acid group (Drug)
Bifidobacterium and ursodeoxycholic acid group
Ursodoxycholic acid, 250mg po tid x 6 months Bifidobacteria, 210 mg po tid x 6 months
干预措施: Bifidobacterium group (Drug)
结局指标
主要结局
The incidence of gallstones in bariatric surgery patients
时间窗: 1 year
次要结局
未报告次要终点
研究者
Xuan Qiu
MD
Shandong Linglong Yingcheng Hospital
