Study on The Efficacy and Safety of Berberine,Amoxicillin and Vonoprazan Containing Triple Therapy in Helicobacter Pylori First-Line Eradication
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- H pylori eradication rates
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of berberine, amoxicillin and vonoprazan containing triple therapy in Helicobacter Pylori first-line eradication. It is hypothesized that berberine hydrochloride, amoxicillin and vonoprazan triple therapy is non-inferior to bismuth-containing quadruple therapy or vonoprazan -containing quadruple therapy. Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed 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 13 and 17.
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
- 是
入选标准
- •Age between 18~70,both gender.
- •Patients with upper gastrointestinal symptoms and with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
- •Patients are willing to receive eradication treatment.
- •Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after the trial.
排除标准
- •Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
- •Patients with contraindications or allergies to the study drug.
- •Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
- •Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the [13C] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).
- •Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.
- •Pregnant or lactating women.
- •Underwent upper gastrointestinal Surgery.
- •Patients with moderate to severe dysplasia or high degree of intraepithelial neoplasia.
- •Patients have symptom of dysphagia.
- •Evidence of bleeding or iron efficiency anemia.
- •A history of malignancy.
- •Drug or alcohol abuse history in the past 1 year.
- •Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
- •Patients who has psychological problem or poor compliance.
- •Enrolled in other clinical trials in the past 3 months.
- •Refuse to sign informed consent.
研究组 & 干预措施
Berberine-containing triple therapy
vonoprazan 20 mg , amoxicillin 1000 mg , and berberine 500 mg by mouth,twice daily for 14 days.
干预措施: Berberine (Drug)
Berberine-containing triple therapy
vonoprazan 20 mg , amoxicillin 1000 mg , and berberine 500 mg by mouth,twice daily for 14 days.
干预措施: Vonoprazan (Drug)
Berberine-containing triple therapy
vonoprazan 20 mg , amoxicillin 1000 mg , and berberine 500 mg by mouth,twice daily for 14 days.
干预措施: Amoxicillin (Drug)
Bismuth-containing quadruple therapy
Bismuth potassium citrate 220 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Amoxicillin (Drug)
Bismuth-containing quadruple therapy
Bismuth potassium citrate 220 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Rabeprazole (Drug)
Bismuth-containing quadruple therapy
Bismuth potassium citrate 220 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Bismuth (Drug)
Bismuth-containing quadruple therapy
Bismuth potassium citrate 220 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Clarithromycin (Drug)
vonoprazan-containing quadruple therapy
Bismuth potassium citrate 220 mg, vonoprazan 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Vonoprazan (Drug)
vonoprazan-containing quadruple therapy
Bismuth potassium citrate 220 mg, vonoprazan 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Amoxicillin (Drug)
vonoprazan-containing quadruple therapy
Bismuth potassium citrate 220 mg, vonoprazan 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Bismuth (Drug)
vonoprazan-containing quadruple therapy
Bismuth potassium citrate 220 mg, vonoprazan 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Clarithromycin (Drug)
结局指标
主要结局
H pylori eradication rates
时间窗: 28 days after treatment
The primary end point of this study is H.pylori eradication,established by negative urea breath test，rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treatment.
次要结局
- symptoms effective rate(14 days of treatment, and 28 days after treatment)
- adverse events(14 days of treatment, and 28 days after treatment)
研究者
Yongquan Shi
professor
Xijing Hospital of Digestive Diseases