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临床试验/NCT02894268
NCT02894268Unknown4 期

Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy as Rescue Treatment for Helicobacter Pylori Infection After Failure of Several Therapy

Sir Run Run Shaw Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

Experimental

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

Experimental

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Weiling Hu, MD,PhD

Clinical Professor

Sir Run Run Shaw Hospital

研究点 (1)

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