Changes of Oral and Intestinal Microbiota After Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-Y Gastric Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of microbiota in oral cavity
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent to participate in the study
- •meeting the eligibility criteria for bariatric treatment (either for LSG or LRYGB).
排除标准
- •treatment with antibiotics within 30 days prior to gathering microbiological material
- •gastrointestinal infections
- •inflammatory bowel disease
- •thyroid diseases
- •cancer (especially the digestive tract)
- •immunodeficiency.
结局指标
主要结局
Change of microbiota in oral cavity
时间窗: 6 months
Change of microbiota in large intestine
时间窗: 6 months
次要结局
未报告次要终点
研究者
Tomasz Stefura
Reasearch Associate, PhD student at 2nd Department of General Surgery, Principal Investigator, Medical Doctor
Jagiellonian University