Family-based Screening and Treatment of Helicobacter Pylori：A Real World Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Patient compliance of performing medical examination.
研究概览
简要总结
The habit of family meals makes the infection rate of Helicobacter pylori high in China, which is also the main cause of reinfection of Helicobacter pylori. Eating together can easily cause family members to be infected with Helicobacter pylori. We used a real-world study to understand the risk factors, epidemiological characteristics, and safety and effectiveness of eradication therapy for helicobacter pylori infection in family-based screening and treatment.
详细描述
Helicobacter pylori infection is a worldwide problem, which is the main cause of gastric cancer. The habit of sharing meals in the family is one of the factors contributing to the high infection rate of HP in China, as well as the main cause of reinfection of HP. Sharing meals can easily cause family members to be infected with HP.Family members live together, eat together, share tableware and other behaviors through the "mouth to mouth" transmission of Helicobacter pylori may be infected with each other, is also one of the reasons for the eradication of many patients after re-infection.At the same time, repeated infection and treatment of Helicobacter pylori will increase the difficulty of Helicobacter pylori reeradication.As a family unit, to study the status of our country family helicobacter pylori infection, epidemiological characteristics, infection risk factor, the different schemes, such as the safety and efficacy of treatment to take measures to reduce the infection rate is of great significance to prevention and treatment of gastric cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community population over 3 years old who signed the informed consent.
- •at least 2 people in the family.
- •living together for at least 10 months each year in the past 5 years except child aged below 5.
排除标准
- •PPI drugs such as esomeprazole、pantoprazole、 rabeprazole,、lansoprazole、famotidine and H2 receptor antagonists were taken within two weeks.
- •antibiotics、bismuth agents or traditional Chinese medicine with antibacterial effect were taken within four weeks
- •There are other factors that researchers think are not suitable for participation
结局指标
主要结局
Patient compliance of performing medical examination.
时间窗: 1 year
Good compliance of medical examination advice was defined as the subjects took the medical advice given by the doctor and the rate of adoption and implementation of the medical examination advice.
Patient compliance of taking medication
时间窗: 1 year
Patient compliance of taking medication is defined as the ratio of the actual dose of medication taken by the patient to the total amount of medication required by the prescription. Good medication compliance is defined as the ratio greater than 80%.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: 1 year
Adverse reactions related to medication were recorded
Eradication rate
时间窗: 1 year
Eradication rate was defined as the ratio of the number of patients diagnosed positive on the carbon 13 breath test to the number of subjects who turned negative after taking the eradication drug to the number of subjects diagnosed positive before taking the drug.
Lesion detection ratio
时间窗: 1 year
The lesion detection ratio was defined as the ratio of the number of subjects who underwent medical examination on the basis of doctor's recommendation and were finally diagnosed with lesion to the number of subjects who underwent examination.
次要结局
- The high-risk factors of Helicobacter pylori infection in families were investigated by questionnaire statistics.(1 year)
研究者
Yanqing Li
Vice president of QiLu Hospital
Shandong University