Comparison of Efficacy of Bismuth Potassium Citrate, Pectin Bismuth Capsules, and Pectin Bismuth Granules in the Treatment of Helicobacter Pylori (Hp) First-line Quadruple Regimen: a Multicenter, Randomized, Prospective, Comparative Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- helicobacter pylori eradication
研究概览
简要总结
This study aims to compare efficacy and safety of bismuth-containing quadruple therapy（with rabeprazole amoxicillin clarithromycin）of different kinds of bismuth（Bismuth potassium citrate, pectin bismuth capsules, pectin bismuth particles）in H. pylori first-line eradication. It is hypothesized that different bismuth containing quadruple therapies have comparable eradication efficacy and safety. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2and 6 follow-up visits, a urea breath test(UBT) 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 28 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath 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 12 and 14.Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18~75,both gender.
- •Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
- •Patients are willing to receive eradication treatment.
- •Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.
排除标准
- •Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
- •Contraindications to study drugs.
- •Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
- •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 Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
- •Evidence of bleeding or iron efficiency anemia.- Page 3 of 4 [DRAFT] -
- •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
Bismuth potassium citrate 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 potassium citrate containing quadruple therapy (Drug)
Bismuth potassium citrate 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: Colloidal pectin bismuth capsules containing quadruple therapy (Drug)
Bismuth potassium citrate 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: Colloidal pectin bismuth particles A quadruple therapy (Drug)
Bismuth potassium citrate 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: Colloidal pectin bismuth particles B quadruple therapy (Drug)
Colloidal pectin bismuth capsules containing quadruple therapy
Colloidal pectin bismuth capsules 200 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Bismuth potassium citrate containing quadruple therapy (Drug)
Colloidal pectin bismuth capsules containing quadruple therapy
Colloidal pectin bismuth capsules 200 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Colloidal pectin bismuth capsules containing quadruple therapy (Drug)
Colloidal pectin bismuth capsules containing quadruple therapy
Colloidal pectin bismuth capsules 200 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Colloidal pectin bismuth particles A quadruple therapy (Drug)
Colloidal pectin bismuth capsules containing quadruple therapy
Colloidal pectin bismuth capsules 200 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Colloidal pectin bismuth particles B quadruple therapy (Drug)
Colloidal pectin bismuth particles A quadruple therapy
Colloidal pectin bismuth particles 150 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Bismuth potassium citrate containing quadruple therapy (Drug)
Colloidal pectin bismuth particles A quadruple therapy
Colloidal pectin bismuth particles 150 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Colloidal pectin bismuth capsules containing quadruple therapy (Drug)
Colloidal pectin bismuth particles A quadruple therapy
Colloidal pectin bismuth particles 150 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Colloidal pectin bismuth particles A quadruple therapy (Drug)
Colloidal pectin bismuth particles A quadruple therapy
Colloidal pectin bismuth particles 150 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Colloidal pectin bismuth particles B quadruple therapy (Drug)
Colloidal pectin bismuth particles B quadruple therapy
Colloidal pectin bismuth particles 300 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Bismuth potassium citrate containing quadruple therapy (Drug)
Colloidal pectin bismuth particles B quadruple therapy
Colloidal pectin bismuth particles 300 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Colloidal pectin bismuth capsules containing quadruple therapy (Drug)
Colloidal pectin bismuth particles B quadruple therapy
Colloidal pectin bismuth particles 300 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Colloidal pectin bismuth particles A quadruple therapy (Drug)
Colloidal pectin bismuth particles B quadruple therapy
Colloidal pectin bismuth particles 300 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
干预措施: Colloidal pectin bismuth particles B quadruple therapy (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 28 days after the end of eradication.
次要结局
- symptoms effective rates(14 days of treatment, and 28 days after treatment)
研究者
Yongquan Shi
Professor
Xijing Hospital of Digestive Diseases