Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- Change of gut microbiome
研究概览
简要总结
The aims of the investigators' study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.
详细描述
Accumulating evidence shows that Helicobacter pylori protects against some metabolic and immunological diseases in which the development of these diseases coincide with temporal or permanent dysbiosis. Helicobacter pylori eradication therapy has the potential to improve symptoms of functional dyspepsia. The aims of our study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who has diagnosed with functional dyspesia by Rome IV criteria
排除标准
- •Known GI malignancy
- •Previous Helicobater pylori eradication history
- •Severe systemic disease
- •Previous GI surgery
- •Uncorrectable coagulopathy: INR > 1.5 or platelet < 50,000/ml
- •Pregnant or breastfeeding women
- •Atrophic gastritis, open type
研究组 & 干预措施
HP eradication group
HP eradication group
Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
干预措施: Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days (Drug)
结局指标
主要结局
Change of gut microbiome
时间窗: at 3 months, and 6 months
Change of gut microbiome at 3 months, and 6 months regardless of Helicobater positive or negative
次要结局
- Eradication of helicobacter pylori(at 3 months)
- Histologic finding of UGI tract(at initial and 3 months)
- Symptom of dyspepsia(at 3 months, and 6 months)
研究者
Kee Wook Jung
Professor
Asan Medical Center