The Effect of Different Time Intervals on Rescue Treatment of Helicobacter Pylori Infection: a Prospective, Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 628
- 试验地点
- 1
- 主要终点
- Eradication rate at different time intervals
研究概览
简要总结
The researchers collect patients who accepted eradication program of the helicobacter pylori but failed to eradicate helicobacter pylor from the outpatient clinic. After rescue therapy, evaluating the effect of retreatment interval on eradication effect of Helicobacter pylori infection.
详细描述
The researchers collect patients who accepted eradication program of the helicobacter pylori but failed to eradicate helicobacter pylor from the outpatient clinic. Record the interval between the last eradication therapy and this time，6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculating the eradication rates, adverse reaction rates, patient compliance of each group. Evaluating the effect of retreatment interval on eradication effect of Helicobacter pylori infection.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-
- •Patients with H.pylori infection (Positive for any of the following: 13C/14C-urea breath test, histopathology test, rapid urease test, stool H.pylori antigen test).
- •Patients who have previously received helicobacter pylori eradication therapy and failed.
排除标准
- •Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
- •Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
- •Patients with active gastrointestinal bleeding.
- •Patients with a history of upper gastrointestinal surgery.
- •Patients allergic to treatment drugs.
- •Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
- •Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
- •Patients who are unwilling or incapable to provide informed consents.
结局指标
主要结局
Eradication rate at different time intervals
时间窗: immediately after the procedure
Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
次要结局
- Patient compliance(Immediately after the procedure)
- Type、Rate and severtiry of adverse reactions(Immediately after the procedure)
研究者
Xiuli Zuo
director of Qilu Hospital gastroenterology department
Shandong University