A Real World Study of Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 959
- 试验地点
- 1
- 主要终点
- helicobacter pylori eradication
研究概览
简要总结
To observe the eradication rate of H. pylori infection, symptom improvement and the incidence of adverse effects in patients using a bismuth colloidal pectin granules quadruple therapy.
详细描述
The study will include three phases: screening, treatment and follow-up. Screening: Patients who have been screened to meet the criteria for naval platooning will be enrolled after signing an informed consent form.
Treatment: Subjects will receive 14 days of eradication treatment. With the exception of colloidal bismuth pectin granules, which will be limited, proton pump inhibitors (PPI) and 2 antibiotics will be selected on the basis of the physician's experience.
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
- Na
- 干预模型
- Single Group
- 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
- •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.
- •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
Quadruple therapy with colloidal bismuth pectin granules
colloidal bismuth pectin granules 150 mg, Selection of 2 antibiotics and 1 proton pump inhibitor based on China's fifth national consensus report on the management of H. pylori infection.All medication is taken orally, twice a day.
干预措施: Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication (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 improvement rates(14 days of treatment, and 28 days after treatment)
研究者
Yongquan Shi
Principal Investigator, Clinical Professor
Xijing Hospital of Digestive Diseases