NCT04892238已完成不适用
Helicobacter Pylori Infection Occurrence in Primary Care Settings in Russia
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology2 个研究点 分布在 1 个国家目标入组 70,000 人开始时间: 2017年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70,000
- 试验地点
- 2
- 主要终点
- Presence of H.pylori infection
研究概览
简要总结
This study is planned to reveal the occurrence rate of H.pylori infection in ambulatory settings' patients in Russia and to compare the occurrence rates in different years in treatment-naïve and previously treated subjects.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •willingness to participate (based on the signed informed consent form);
- •age older than 12 y.o. (for subjects younger than 18 y.o. written informed consent of a legal representative was obligatory);
- •availability of demographic data and medical history, including previous treatment for H.pylori infection
- •For subjects of "treatment-naïve" group:
- •no previous treatment for H.pylori infection in the anamnesis;
- •at least 6 weeks after previous use of any antimicrobial agents for any reason;
- •at least 2 weeks' time frame free of use of proton pump inhibitors, other anti-secretory agents and bismuth preparations.
- •For "Previously treated" group of subjects:
- •infection caused by H.pylori established earlier and
- •not less than 6 weeks after the end of eradication therapy with at least 2 antibiotics and a proton pump inhibitor for at least 7 days, based on a patient's report
排除标准
- •history of surgery on chest, stomach, gut (excluding appendectomy or laparoscopic cholecystectomy performed more than 6 month before the enrolment);
- •advanced stage of chronic obstructive pulmonary disease,
- •allergies to citruses,
- •pregnant and breastfeeding women.
结局指标
主要结局
Presence of H.pylori infection
时间窗: during the procedure
Delta over the baseline (δ) of 13C/12C based on the results of the initial and second samples ≥4.0‰ are positive
次要结局
未报告次要终点
研究者
Sergey Morozov
Leading researcher
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
研究点 (2)
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