Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment of Different Tetracycline Doses

Study Overview
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Brief Summary
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The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a dose and frequency of tetracycline 500mg tid or qid of bismuth quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

Detailed Description
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The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a dose and frequency of tetracycline 500mg tid or qid of bismuth-containing quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results. After all subjects were tested, the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group were calculated. According to the course of treatment, it is randomized into a tid treatment group and a qid treatment group. The two groups of bismuth quadruple regimens are the same, as follows: Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 20mg bid Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 20mg bid

Official Title
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Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment: A Multicenter Randomized Clinical Trial of Different Tetracycline Doses and Frequencies.

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Amoxicillin
* Drug: Tetracycline tid
* Drug: Tetracycline qid
* Drug: Bismuth Potassium Citrate
* Drug: Colloidal Bismuth Pectin
* Drug: Esomeprazole 20mg


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 rapid urease test or 13C/14C-urea breath test). Patients who have never received H. pylori eradication treatment. 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This trial is a multi-center, open-label, non-inferiority, randomized controlled trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tid group<br>Tid group: Amoxicillin 1000mg bid+ Tetracycline 500mg tid+ Bismuth + Esomeprazole 20mg bid | Drug: Amoxicillin<br>* Included in quadruple eradication medication.<br>Drug: Tetracycline tid<br>* Included in quadruple eradication medication.<br>Drug: Bismuth Potassium Citrate<br>* Included in quadruple eradication medication.<br>Drug: Colloidal Bismuth Pectin<br>* Included in quadruple eradication medication.<br>Drug: Esomeprazole 20mg<br>* Included in quadruple eradication medication.<br>|
| Active Comparator: Qid group<br>Qid group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Esomeprazole 20mg bid | Drug: Amoxicillin<br>* Included in quadruple eradication medication.<br>Drug: Tetracycline qid<br>* Included in quadruple eradication medication.<br>Drug: Bismuth Potassium Citrate<br>* Included in quadruple eradication medication.<br>Drug: Colloidal Bismuth Pectin<br>* Included in quadruple eradication medication.<br>Drug: Esomeprazole 20mg<br>* Included in quadruple eradication medication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate | 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 follow-up check. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse reactions | Rate of adverse reactions | Immediately after follow-up check. | 
| 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 follow-up check. | 
| Cost-effectiveness index | Ratio of costs to effectiveness | Immediately after follow-up check. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, tetracycline, Bismuth-containing quadruple regimen