Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Patients will be followed up at the 1st day, 14th day, and 4 weeks after the treatment, respectively, and all side effects will be collected.

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

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Doxycycline
* Drug: Furazolidone
* Drug: Esomeprazole
* Drug: Colloidal Bismuth Subcitrate
* Drug: Sensitivity antibiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A positive 13 C-urea breath test Formal H.pylori treatment more than two times Age >18 years Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regimen A<br>esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg | Drug: Doxycycline<br>* Doxycycline 100g po bid<br>* Other names: Vibramycin;Drug: Furazolidone<br>* Furazolidone 100mg po bid<br>* Other names: Giarlan;Drug: Esomeprazole<br>* Esomeprazole 20mg po bid<br>* Other names: Nexium;Drug: Colloidal Bismuth Subcitrate<br>* Bismuth 20mg po bid<br>* Other names: PIDI;|
| Active Comparator: Regimen B<br>two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg | Drug: Esomeprazole<br>* Esomeprazole 20mg po bid<br>* Other names: Nexium;Drug: Colloidal Bismuth Subcitrate<br>* Bismuth 20mg po bid<br>* Other names: PIDI;Drug: Sensitivity antibiotics<br>* Two antibiotics based on antibiotic sensitivity of H.pylori culture, including amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline and furazolidone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H. pylori eradication rate | Repeat 13-Urea breath test 42 days after H.pylori eradication | 42 days after start of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response as measured by Number of participants whose symptoms disappear or improve after eradication treatment | Number of participants whose symptoms disappear or improve after eradication treatment. | 14 days and 42 days after H.pylori eradication | 
| Side effects | Adverse Events That Are Related to Eradication Treatment | 14 days after start of therapy | 
| Adherence rate | Number of patients who take at least 80% drugs | 14 days after start of therapy |