The Efficacy of 10-day or 14-day Course of Bismuth-containing Quadruple Therapy:A Randomized Clinical Trial

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 10-day or 14-day course of Tegoprazan bismuth-containing quadruple eradication therapy at 6 weeks after treatment, subjects underwent another 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 10-day or 14-day course of Tegoprazan 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 10-day treatment group and a 14-day treatment group. The two groups of bismuth quadruple regimens are the same, as follows: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid

Official Title
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The Efficacy of Bismuth-containing Quadruple Therapy in the First-line Treatment of Helicobacter Pylori Infection in 10 Days and 14 Days: a Prospective, Randomized, Controlled Study

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: 10-day Tegoprazan bismuth-containing quadruple therapy


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 not previously received helicobacter pylori eradication therapy 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10-day treatment group<br>10-day Tegoprazan bismuth-containing quadruple therapy Tegoprazan（Luo Xin Pharmaceutical Group Co. LTD）50mg bid Amoxicillin (Amoxicillin, United Laboratories Co., LTD) 1000mg bid Tetracycline (Huanan Brand, Guangdong Huanan Pharmaceutical Co. LTD.) 500mg qid Bismuth potassium Citrate (Lizhu Delle, Lizhu Group Pharmaceutical Factory) 2g bid | Drug: 10-day Tegoprazan bismuth-containing quadruple therapy<br>* 10-day Tegoprazan bismuth-containing quadruple therapy: Tegoprazan（Luo Xin Pharmaceutical Group Co. LTD）50mg bid Amoxicillin (Amoxicillin, United Laboratories Co., LTD) 1000mg bid Tetracycline (Huanan Brand, Guangdong Huanan Pharmaceutical Co. LTD.) 500mg qid Bismuth potassium Citrate (Lizhu Delle, Lizhu Group Pharmaceutical Factory) 2g bid<br>|
| Active Comparator: 14-day treatment group<br>14-day Tegoprazan bismuth-containing quadruple therapy Tegoprazan（Luo Xin Pharmaceutical Group Co. LTD）50mg bid Amoxicillin (Amoxicillin, United Laboratories Co., LTD) 1000mg bid Tetracycline (Huanan Brand, Guangdong Huanan Pharmaceutical Co. LTD.) 500mg qid Bismuth potassium Citrate (Lizhu Delle, Lizhu Group Pharmaceutical Factory) 2g bid | Drug: 10-day Tegoprazan bismuth-containing quadruple therapy<br>* 10-day Tegoprazan bismuth-containing quadruple therapy: Tegoprazan（Luo Xin Pharmaceutical Group Co. LTD）50mg bid Amoxicillin (Amoxicillin, United Laboratories Co., LTD) 1000mg bid Tetracycline (Huanan Brand, Guangdong Huanan Pharmaceutical Co. LTD.) 500mg qid Bismuth potassium Citrate (Lizhu Delle, Lizhu Group Pharmaceutical Factory) 2g bid<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 the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse reactions | Rate 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 | 
| Cost-effectiveness index | Ratio of costs to effectiveness | immediately after the procedure |