Changes of Oral and Intestinal Microbiota After Bariatric Surgery
Changes of Oral and Intestinal Microbiota After Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-Y Gastric Bypass
Purpose
The aim of this study was to analyze the changes of microbiota among patients undergoing LSG or LRYGB on two levels of gastrointestinal tract (using oral swab and stool sample). We compared samples from patients before and after bariatric operation.
Materials and methods This prospective cohort study was conducted in one academic, teaching hospital. The recommendations of the Metabolic and Bariatric Surgery Section of the Polish Surgical Society were used as indication for surgery, that is: Body Mass Index (BMI) ≥35 kg/m2 with obesity-related comorbidities or BMI ≥40 kg/m2.
Analysis and endpoints
Primary endpoint was to determine the difference in microbiota present in oral cavity and large intestine between patients before and after bariatric surgery. Secondary endpoint was to compare the difference in microbiota changes between patients undergoing LSG and LRYGB
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Małopolska
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Cracovia、Małopolska、波兰、30-688
- 2nd Department of General Surgery, Jagiellonian University Medical College
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- informed consent to participate in the study
- meeting the eligibility criteria for bariatric treatment (either for LSG or LRYGB).
Exclusion Criteria:
- treatment with antibiotics within 30 days prior to gathering microbiological material
- gastrointestinal infections
- inflammatory bowel disease
- thyroid diseases
- cancer (especially the digestive tract)
- immunodeficiency.
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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LSG
Patients undergoing laparoscopic sleeve gastrectomy.
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Surgical treatment of morbid obesity.
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LRYGB
Patients undergoing laparoscopic Roux-en-Y gastric bypass.
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Surgical treatment of morbid obesity.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change of microbiota in oral cavity
大体时间：6 months
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6 months
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Change of microbiota in large intestine
大体时间：6 months
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6 months
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Bariatric surgery的临床试验
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St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences Organization完全的
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Seoul National University HospitalJohnson & Johnson Medical Companies完全的