NCT05810805尚未招募不适用
Measurement and Analysis of Gas Composition in Digestive Tract: a Prospective, Single-center Observational Study
Xiuli Zuo1 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2023年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Concentrations of different gas in digestive tract
研究概览
简要总结
The purpose of this study is to detect the concentration of various gases，including hydrogen, methane, hydrogen sulfide, nitric oxide in different parts of the digestive tract by a safe and direct method, and to establish a human digestive tract gas profiles. Analyze the differences in gas components in different segments of the digestive tract in patients with different diseases, and analyze the correlation between specific gases and digestive tract diseases and non-specific symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 to 70 years.
- •Patients undergoing endoscopic examination
排除标准
- •Patients with serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, coronary heart disease (angina pectoris or coronary artery stenosis ≥ 75%).
- •Patients have history of gastrointestinal surgery
- •Patients who failed to complete the endoscopic examination due to various reasons
- •Patients Boston score of Bowel preparation≤ 6 points
- •Patients who have medication history of probiotics, antibiotics, PPIs and prokinetic drugs in the last 4 weeks
- •Patients who combined with thyroid disease and other diseases that affect gastrointestinal motility
- •Patients who combined with other risk factors such as mental illness, alcoholism, and drug abuse
- •Patients who unable or unwilling to provide informed consent
结局指标
主要结局
Concentrations of different gas in digestive tract
时间窗: immediately after the procedure
Concentrations of H2, CH4, NO and H2S in various parts of digestive tract
次要结局
- Correlation between digestive tract and breath test(Immediately after the procedure)
- The correlation between the severity of gastrointestinal symptoms and gas concentrations in various parts of the digestive tract.(Immediately after the procedure)
- Differences in concentrations of H2, CH4, NO, and H2S in the digestive tract between patients with different gastrointestinal diseases and normal individuals.(Immediately after the procedure)
研究者
Xiuli Zuo
director of Qilu Hospital gastroenterology department
Shandong University
研究点 (1)
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