The Efficacy of Bismuth-containing Quadruple Therapy in the First-line Treatment of Helicobacter Pylori Infection in 10 Days and 14 Days: a Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 398
- 试验地点
- 1
- 主要终点
- Eradication rate
研究概览
简要总结
The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of Tegoprazan bismuth-containing quadruple eradication therapy at 6 weeks after treatment, subjects underwent another 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.
详细描述
The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a 10-day or 14-day course of Tegoprazan bismuth-containing quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results.
After all subjects were tested, the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group were calculated.
According to the course of treatment, it is randomized into a 10-day treatment group and a 14-day treatment group. The two groups of bismuth quadruple regimens are the same, as follows:
Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 not previously received helicobacter pylori eradication therapy
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.
研究组 & 干预措施
10-day treatment group
10-day Tegoprazan bismuth-containing quadruple therapy Tegoprazan（Luo Xin Pharmaceutical Group Co. LTD）50mg bid Amoxicillin (Amoxicillin, United Laboratories Co., LTD) 1000mg bid Tetracycline (Huanan Brand, Guangdong Huanan Pharmaceutical Co. LTD.) 500mg qid Bismuth potassium Citrate (Lizhu Delle, Lizhu Group Pharmaceutical Factory) 2g bid
干预措施: 10-day Tegoprazan bismuth-containing quadruple therapy (Drug)
14-day treatment group
14-day Tegoprazan bismuth-containing quadruple therapy Tegoprazan（Luo Xin Pharmaceutical Group Co. LTD）50mg bid Amoxicillin (Amoxicillin, United Laboratories Co., LTD) 1000mg bid Tetracycline (Huanan Brand, Guangdong Huanan Pharmaceutical Co. LTD.) 500mg qid Bismuth potassium Citrate (Lizhu Delle, Lizhu Group Pharmaceutical Factory) 2g bid
干预措施: 10-day Tegoprazan bismuth-containing quadruple therapy (Drug)
结局指标
主要结局
Eradication rate
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
- Rate of adverse reactions(immediately after the procedure)
- Cost-effectiveness index(immediately after the procedure)
- Patient compliance(immediately after the procedure)
研究者
Xiuli Zuo
Director of Qilu Hospital gastroenterology department
Shandong University