跳至主要内容
临床试验/NCT01431651
NCT01431651Unknown不适用

Asian Pacific Weight Loss and Metabolic Surgery Center

Min-Sheng General Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Questionnaire of gastrointestinal quality of life

研究概览

简要总结

Obesity has been a global epidemic. Currently, bariatric surgery has been recognized as the only successful treatment for morbid obesity. Laparoscopic gastric bypass (LGB) is the leading bariatric surgery worldwide including Taiwan, it's resulted in significant weight loss and resolution of metabolic co-morbidities in morbidly obese patients .

However, annoyed Gastro-Intestinal (GI) symptoms are a common complaint after gastric bypass like foul smell flatus, oil flatus and over flatus. The aim of this study was to determine whether probiotics would improve annoyed GI symptoms after gastric bypass.

Probiotics are live microorganisms (in most cases, bacteria) that are similar to beneficial microorganisms found in the human gut. They are also called "friendly bacteria" or "good bacteria." Probiotics are available to consumers mainly in the form of dietary supplements and foods.

详细描述

Probiotics are available in foods and dietary supplements (for example, capsules, tablets, and powders) and in some other forms as well. Examples of foods containing probiotics are yogurt, fermented and unfermented milk, miso, and some juices and soy beverages. In probiotic foods and supplements, the bacteria may have been present originally or added during preparation. In this study, we investigate the efficacy of probiotics for alleviating the annoyed GI symptoms after LGB.

Clostridium butyricum Probiotics is a novel microecological feed additive, it has the characteristic of heat tolerance, acid tolerance and antibiotic resistance and is general used to treat the intestinal tract disease in the clinical treatment. Its potential function in the situation that feed has been added universally with antibiotics will make it have a good development.

This randomized, placebo-controlled, double blind, prospective clinical trial was conducted among 60 patients undergoing gastric bypass for morbid obesity who had annoyed GI symptoms. Patients were randomized to the clostridium butyricum MIYAIRI group (80 mg daily , n=20,), bifidobacterium Longum BB536 group (2 packs daily, n=20),and biotase group(4 tablets daily, n=20). Control group (Biotase per day). Quality of life was measured and compared by the gastro-intestinal quality of life index (GIQLI) before and two weeks after in both groups. The higher score means that they have better quality of life. Through this study, we hope that we can find a effective probiotics can help all the patient received gastric bypass and bothered by their gastrointestinal problems also can improve their satisfaction of this operation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • morbid obesity patients after gastric bypass with annoyed intestinal symptoms

排除标准

  • cannot obey the orders to take medicine

结局指标

主要结局

Questionnaire of gastrointestinal quality of life

时间窗: two weeks after taken drugs

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

WEI-CHENG YAO

Min-Sheng general hospital IRB

Min-Sheng General Hospital

研究点 (2)

Loading locations...

相似试验