The Effect of Time Intervals for Rescue Treatment on Eradication Effect of Helicobacter Pylori Infection

Study Overview
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Brief Summary
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The researchers collect patients who accepted eradication program of the helicobacter pylori but failed to eradicate helicobacter pylor from the outpatient clinic. After rescue therapy, evaluating the effect of retreatment interval on eradication effect of Helicobacter pylori infection.

Detailed Description
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The researchers collect patients who accepted eradication program of the helicobacter pylori but failed to eradicate helicobacter pylor from the outpatient clinic. Record the interval between the last eradication therapy and this time，6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculating the eradication rates, adverse reaction rates, patient compliance of each group. Evaluating the effect of retreatment interval on eradication effect of Helicobacter pylori infection.

Official Title
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The Effect of Different Time Intervals on Rescue Treatment of Helicobacter Pylori Infection: a Prospective, Multicenter Observational Study

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. Patients with H.pylori infection (Positive for any of the following: 13C/14C-urea breath test, histopathology test, rapid urease test, stool H.pylori antigen test). Patients who have previously received helicobacter pylori eradication therapy and failed. Exclusion Criteria: Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial. Patients with active gastrointestinal bleeding. Patients with a history of upper gastrointestinal surgery. Patients allergic to treatment drugs. Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse Patients who are unwilling or incapable to provide informed consents.

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 |
| --- | --- |
| Remedial treatment within 3 months<br> | Other: Remedial treatment within 3 months<br>* The interval between the time of this treatment and the last day of the last therapy is within 3 months.Patients in Amoxicillin + Tetracycline + Bismuth + Esomeprazole quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Esomeprazole 40mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Vonoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Vonoprazan 20mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Tegoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Tegoprazan 50mg bid for 14d.<br>|
| Remedial treatment within 3 to 6 months<br> | Other: Remedial treatment within 3 to 6 months<br>* The interval between the time of this treatment and the last day of the last therapy is 3-6 months. Patients in Amoxicillin + Tetracycline + Bismuth + Esomeprazole quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Esomeprazole 40mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Vonoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Vonoprazan 20mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Tegoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Tegoprazan 50mg bid for 14d.<br>|
| Remedial treatment within 6 to 12 months<br> | Other: Remedial treatment within 6 to 12 months<br>* The interval between the time of this treatment and the last day of the last therapy is 6-12 months Patients in Amoxicillin + Tetracycline + Bismuth + Esomeprazole quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Esomeprazole 40mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Vonoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Vonoprazan 20mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Tegoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Tegoprazan 50mg bid for 14d.<br>|
| Remedial treatment after 12 months<br> | Other: Remedial treatment after 12 months<br>* The interval between the time of this treatment and the last day of the last therapy is more than 12 months Patients in Amoxicillin + Tetracycline + Bismuth + Esomeprazole quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Esomeprazole 40mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Vonoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Vonoprazan 20mg bid for 14d. Patients in Amoxicillin + Tetracycline + Bismuth + Tegoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Tegoprazan 50mg bid for 14d.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate at different time intervals | 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 two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up. | immediately after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type、Rate and severtiry of adverse reactions | Type、Rate and severtiry of adverse reactions | Immediately after the procedure | 
| Patient compliance | Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken. | Immediately after the procedure |