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临床试验/NCT03247101
NCT03247101Unknown不适用

Probiotics for Gallstones in Post-bariatric Surgery Patients:A Prospective

Min-Sheng General Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Miyarisan-BM (Clostridium Butyricum Miyairi) 40 mg po tid x 6 months

干预措施: Miyarisan-BM (Clostridium Butyricum Miyairi) (Drug)

Urso group

Active Comparator

ursodoxycholic acid, 200mg po tid x 6 months

干预措施: Urso group (Drug)

Biotase group

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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