Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy as Rescue Treatment for Helicobacter Pylori Infection After Failure of Several Therapy
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- H. pylori eradication rate
研究概览
简要总结
Doxycycline- and Furazolidone-containing Quadruple Regimen can be a successful rescue treatment for Helicobacter pylori Infection patients after Failure of several therapy. It is superior of tailored therapy as rescue treatment for helicobacter pylori Infection after failure of several therapy.
详细描述
This study is a prospective, multiple centers, randomized trial. Patients who had failed in previous H. pylori eradication treatment that more than two times will be enrolled in Sir Run Run Shaw Hospital.
Pretreatment H. pylori status will be defined by a positive 13 C-urea breath test (13 C-UBT). Patients who had received bismuth compounds, acid inhibitor, or antibiotics during 4 weeks before 13 C-UBT are excluded. Other exclusion criteria included upper gastrointestinal surgery, malignancy, and evidence of blood dyscrasia.
After the patient is enrolled the patient will sign the informed consent and receive gastroscopy. More than four biopsy will be given including two in antrum and two in gastric body. One pair of biopsy sample will be sent for the pathology and the other pair is used for H.pylori culture and antibiotics sensitivity. After we get the result of antibiotics sensitivity the patient will be divided randomly into two groups, Regimen A, Regimen B.
The Regimen A includes esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg . All drugs are taken twice a day for 14 days. The Regimen B includes two antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg. The esomeprazole and bismuth are taken half an hour before a meal and antibiotics after the meal.
All patients are asked to quit smoking and drinking and forbid eating foods rich in tyramine (e.g., chicken, cheese, pickles, lentils, beans) and seafood during and in 1 week after the treatment.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A positive 13 C-urea breath test
- •Formal H.pylori treatment more than two times
- •Age >18 years
排除标准
- •Bismuth compounds, acid inhibitor, or antibiotics during 4 weeks before the patient is enrolled
- •Allergic to the medications
- •Upper gastrointestinal surgery history
- •Serious heart insufficiency, liver insufficiency, renal insufficiency and other serious medical problems
- •Evidence of blood dyscrasia
- •Pregnant and lactating women
- •Can't express his complain correctly and can't cooperate with the researcher
研究组 & 干预措施
Regimen A
esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg
干预措施: Doxycycline (Drug)
Regimen A
esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg
干预措施: Furazolidone (Drug)
Regimen A
esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg
干预措施: Esomeprazole (Drug)
Regimen A
esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg
干预措施: Colloidal Bismuth Subcitrate (Drug)
Regimen B
two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg
干预措施: Esomeprazole (Drug)
Regimen B
two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg
干预措施: Colloidal Bismuth Subcitrate (Drug)
Regimen B
two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg
干预措施: Sensitivity antibiotics (Drug)
结局指标
主要结局
H. pylori eradication rate
时间窗: 42 days after start of therapy
Repeat 13-Urea breath test 42 days after H.pylori eradication
次要结局
- Clinical response as measured by Number of participants whose symptoms disappear or improve after eradication treatment(14 days and 42 days after H.pylori eradication)
- Side effects(14 days after start of therapy)
- Adherence rate(14 days after start of therapy)
研究者
Weiling Hu, MD,PhD
Clinical Professor
Sir Run Run Shaw Hospital
