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临床试验/NCT06287931
NCT06287931招募中不适用

Probiotics for Gallstones in Post-bariatric Surgery Patients

Shandong Linglong Yingcheng Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Ursodoxycholic acid, 250mg po tid x 6 months

干预措施: Ursodoxycholic acid group (Drug)

Bifidobacterium group

Experimental

Bifidobacteria, 210 mg po tid x 6 months

干预措施: Bifidobacterium group (Drug)

Bifidobacterium and ursodeoxycholic acid group

Experimental

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

Experimental

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

发起方
Shandong Linglong Yingcheng Hospital
申办方类型
Network
责任方
Principal Investigator
主要研究者

Xuan Qiu

MD

Shandong Linglong Yingcheng Hospital

研究点 (1)

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