Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspepsia Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,242
- 试验地点
- 26
- 主要终点
- Relief of Helicobacter pylori related dyspepsia
研究概览
简要总结
The objectives of this multicenter, prospective, observational study were to investigate the incidence of dyspeptic symptoms in patients with Helicobacter pylori (H. pylori) infection and to continuously follow up the remission of dyspeptic symptoms after H. pylori eradication, so as to provide reference for the clinical diagnosis and treatment strategies of patients with H. pylori infection and dyspeptic symptoms.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18-80 years
- •H. pylori infection diagnosed by 13C/ 14C-UBT (> 2 times the cutoff value) and/or gastroscopy (rapid urease strong positive and histological positive)
- •Treatment-naive patients with Helicobacter pylori
- •Ability and willingness to participate in the study and to sign and give informed consent
排除标准
- •Under 18 or over 80 years old
- •Organic digestive diseases, such as active peptic ulcer, gastroesophageal reflux, gastrointestinal bleeding, acute/chronic pancreatitis, acute/chronic cholecystitis, gallstones, intestinal obstruction, inflammatory bowel disease, etc.
- •Combined with melena, hematemesis, anemia, emaciation and other alarm symptoms
- •Pregnant and lactating women
- •History of cancer
- •History of subtotal gastrectomy
- •Severe organ dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases, such as grade IV heart failure, liver failure, uremia, respiratory failure, hemophilia, Wilson's disease, etc.
结局指标
主要结局
Relief of Helicobacter pylori related dyspepsia
时间窗: Patients with dyspepsia who have successfully eradicated Helicobacter pylori infection will be followed up for dyspepsia symptoms after 2 months and after 6 months to assess the remission of dyspepsia symptoms
The Functional Dyspepsia Symptom Diary (FDSD) will be used to evaluate the dyspepsia symptoms of the patients
the incidence of dyspepsia in patients with Helicobacter pylori infection
时间窗: Time 0 when finished the Epidemiological questionnaire and Functional Dyspepsia Symptom Diary
Proportion of patients with Helicobacter pylori infection with dyspeptic symptoms
次要结局
未报告次要终点
研究者
Hong Lu, MD
Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine
RenJi Hospital