A Study About the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure

Study Overview
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Brief Summary
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The patients who accepted the quadruple eradication program of the helicobacter pylori but failed to eradicate helicobacter pylori will be assessed the most suitable re-eradication time of helicobacter pylori.

Detailed Description
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Helicobacter pylori (HP) infection is a common global infectious disease, which is an important cause of chronic gastritis, peptic ulcer and gastric cancer. At present, due to the non-standard Helicobacter pylori eradication program in clinical work, poor patient compliance and other reasons, the phenomenon of HP eradication treatment failure is more and more common. However, there is still no conclusion on the most appropriate time for remedial treatment inpatients with Hp eradication failure.

Official Title
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A Study About the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Other: Remedial treatment within 3 months
* Other: Remedial treatment within 3 to 6 months
* Other: Remedial treatment within 6 to 12 months
* Other: Remedial treatment after 12 months


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-70 with H. pylori infection. Patients with previous Helicobacter pylori eradication. Exclusion Criteria: Patients treated with H2-receptor antagonist, PPI, bismuth and antibioticsin the previous 4 weeks. Patients with gastrectomy, acute GI bleeding and advanced gastric cancer. Patients with known or suspected allergy to study medications. Currently pregnant or lactating. Inability to provide informed consent and other situations that couldinterfere with the examination or therapeutic protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group A<br>Within 3 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d. | Other: Remedial treatment within 3 months<br>* Remedial therapy was performed within 3 months<br>|
| group B<br>Within 3 to 6 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d. | Other: Remedial treatment within 3 to 6 months<br>* Remedial therapy was performed within 3 to 6 months<br>|
| group C<br>Within 6 to 12 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d. | Other: Remedial treatment within 6 to 12 months<br>* Remedial therapy was performed within 6 to 12 months<br>|
| group D<br>After 12 months of treatment failure in the course of Helicobacter pylori infection,Patients will receive esomeprazole (Nexium) 40mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, amoxicillin1000mg po bid and tetracycline 500 mg po qid (or tetracycline 500 mg po tid) for 14d. | Other: Remedial treatment after 12 months<br>* Remedial therapy was performed after 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The most suitable re-eradication time | The most suitable re-eradication time#The unit is month# will be assessed by paired comparison method . | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rates in three groups | Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in three groups | 12 months |