Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Helicobacter pylori eradication
研究概览
简要总结
This study aims to evaluate the efficacy of vonoprazan combined with different antibiotics in dual therapy for Helicobacter pylori eradication treatment. Newly infected patients were randomly assigned to four groups: amoxicillin dual therapy, tetracycline dual therapy, minocycline dual therapy, and bismuth quadruple therapy. At the follow - up visit in the 6th week, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be conducted to confirm eradication.
详细描述
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 14 and 16.
Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test#rapid urease test or helicobacter pylori stool antigen test.
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
- •Aged 18 - 70 years, regardless of gender;
- •Patients with definite Hp infection (positive result in any one of the 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) who have never received Helicobacter pylori eradication treatment;
- •For women of child - bearing age, it is required to use medically acceptable contraceptive methods during the trial period and within 30 days after the end of the trial.
排除标准
- •Patients who have been definitely diagnosed with Hp infection and have received antibiotic eradication treatment;
- •Patients with contraindications to the study drug or who are allergic to the study drug;
- •Patients with severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases;
- •Patients who have been continuously using anti - ulcer drugs (including taking PPI within 2 weeks before the Hp infection test), antibiotics or bismuth complexes (more than 3 times a week within 1 month before screening);
- •Pregnant and lactating women;
- •Patients who have undergone upper gastrointestinal surgery;
- •Patients with moderate or severe atypical hyperplasia or high - grade intraepithelial neoplasia;
- •Patients with symptoms of dysphagia;
- •Patients with evidence of bleeding or iron - deficiency anemia;
- •Patients with a history of malignant tumors;
- •Patients with a history of drug or alcohol abuse within the past 1 year;
- •Patients who are using systemic glucocorticoids, non - steroidal anti - inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for using aspirin ≤ 100 mg/d);
- •Patients with mental disorders;
- •Patients who have participated in other clinical trials within the past 3 months;
- •Patients who refuse to sign the informed consent form.
研究组 & 干预措施
Vonoprazan - amoxicillin dual therapy
Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days
干预措施: Vonoprazan (Drug)
Vonoprazan - amoxicillin dual therapy
Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days
干预措施: Amoxicillin (Drug)
Vonoprazan-tetracycline dual therapy
Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days
干预措施: Vonoprazan (Drug)
Vonoprazan-tetracycline dual therapy
Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days
干预措施: Tetracycline 500mg tid (Drug)
Vonoprazan-minocycline dual therapy
Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days
干预措施: Vonoprazan (Drug)
Vonoprazan-minocycline dual therapy
Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days
干预措施: Minocycline (Drug)
Bismuth-containing quadruple therapy
Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
干预措施: Vonoprazan (Drug)
Bismuth-containing quadruple therapy
Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
干预措施: Bismuth (Drug)
Bismuth-containing quadruple therapy
Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
干预措施: Clarithromycin 500 mg (Drug)
Bismuth-containing quadruple therapy
Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Helicobacter pylori eradication
时间窗: 28 days after treatment
The primary end point of this study is H.pylori eradication#established by negative \[13C\] urea breath test #DOB value below 3.9#28 days after the end of eradication
次要结局
- adverse events(14 days of treatment, and 28 days after treatment)
研究者
Yongquan Shi
Professor
Xijing Hospital of Digestive Diseases