NCT02819037已完成不适用
Modification of Digestive Flora After Gastric Bypass : Pilot Study on Microbial Overgrowth Using Gas Chromatography
Lille Catholic University4 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2016年5月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Changes in expired hydrogen H2 concentration
研究概览
简要总结
The objective of this research is to determine the incidence of microbial overgrowth of the small intestine before and after a gastric bypass. For this purpose, the study is based on the analysis of the expired hydrogen H2 with gas chromatography before surgery and at 1, 3, 6, 12, 18 and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Severe obesity (BMI>35kg/m² with at least one comorbidity or BMI>40kg/m² without comorbidity) and after medical care for at least 6 months
- •Patient who will follow bariatric surgery by bypass gastric
- •Social insurance affiliation
- •Signature of the informed consent
排除标准
- •Contraindication criteria for bariatric surgery (cognitive or mental severe disorders, severe and non-stabilized eating disorders, etc.)
- •Chronic inflammatory bowel disease (Crohn's disease, hemorrhagic rectocolitis)
- •Previous intestinal surgery
- •Antibiotic periodicity treatment of less than 3 months
- •Other diseases responsible for bacterial overgrowth
- •Pregnancy or breastfeeding
研究组 & 干预措施
Gas chromatography and stool analysis
Experimental
gas chromatography and stool analysis for detection of malabsorption
干预措施: gas chromatography (Procedure)
Gas chromatography and stool analysis
Experimental
gas chromatography and stool analysis for detection of malabsorption
干预措施: Stool analysis for detection of malabsorption (Procedure)
结局指标
主要结局
Changes in expired hydrogen H2 concentration
时间窗: change at baseline et up to 24 months
Measured by gas chromatography
次要结局
- Changes in intestinal transit(change at baseline et up to 24 months)
- Changes in malabsorption(change at baseline et up to 24 months)
- Changes in digestive symptoms(change at baseline et up to 24 months)
研究者
研究点 (4)
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