Family-based Screening and Treatment of Helicobacter Pylori：A Real World Study
2021年10月11日 更新者：Yanqing Li、Shandong University
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (预期的)
400
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Li Yanqing, PhD
- 电话号码：053182169385
- 邮箱：liyanqing@sdu.edu.cn
研究联系人备份
- 姓名：Li Yueyue, PhD
- 电话号码：18560089751
- 邮箱：lyynqj@126.com
学习地点
-
-
Shandong
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Jinan、Shandong、中国、250012
- 招聘中
- Department of Gastroenterology,Qilu Hospital,Shandong University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
3年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Community population aged above 3 years in family unit,The family unit is determined by actual living together rather than household registration relationship, with at least 2 people in the family and living together for at least 10 months each year in the past 5 years.
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：以家庭为基础
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Family members in the study
Community groups that meet the inclusion criteria
|
Patients with positive Helicobacter pylori infection were determined by carbon 13 breath test ,The diagnosis and treatment of positive patients were followed up without other intervention.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient compliance of performing medical examination.
大体时间：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.
|
1 year
|
|
Patient compliance of taking medication
大体时间：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%.
|
1 year
|
|
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
大体时间：1 year
|
Adverse reactions related to medication were recorded
|
1 year
|
|
Lesion detection ratio
大体时间：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.
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1 year
|
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Eradication rate
大体时间：1 year
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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.
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1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The high-risk factors of Helicobacter pylori infection in families were investigated by questionnaire statistics.
大体时间：1 year
|
Questionnaire survey was used to conduct information statistics on families undergoing Helicobacter pylori screening.Statistics include family members of the general situation, basic information, personal health and life habit, individual disease history, personal nearly 1 month medications, family health and lifestyle, family history, history of HP infection and the eradication of history, screening results, doctor give opinions and patient adherence and follow-up outcome after screening process, etc. Statistical soft ware was used to analyze factor correlations.
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1 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Li Yanqing, PhD、Qilu Hospital, Shandong University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年7月10日
初级完成 (预期的)
2022年5月1日
研究完成 (预期的)
2022年6月1日
研究注册日期
首次提交
2021年6月25日
首先提交符合 QC 标准的
2021年6月29日
首次发布 (实际的)
2021年7月9日
研究记录更新
最后更新发布 (实际的)
2021年10月12日
上次提交的符合 QC 标准的更新
2021年10月11日
最后验证
2021年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.