Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori（SHARE2302)

Study Overview
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Brief Summary
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Helicobacter pylori (H. pylori) infection is a common global infectious disease of the gastrointestinal tract. Helicobacter pylori eradication can effectively prevent the development of stomach cancer.The researchers collect H.pylori-positive patients who need native therapy. The subjects were randomized to receive7 days and 14 days 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 and patient compliance of each group.

Detailed Description
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Related studies have shown that 7-day bismuth quadruple therapy is not inferior to 14-day bismuth quadruple therapy in the eradication of clarithromycin-resistant H. pylori.The results of the current study conducted by our team on the eradication of H. pylori in 10-day versus 14-day courses of bismuth quadruple therapy showed that the 10-days (92.09%) was not inferior to the 14-days(92.38%), but the incidence of adverse effects was significantly lower in the 10-day courses than in the 14-days(30.62%). If it can be demonstrated that the eradication rate of the 7-day course of bismuth quadruplex is close to that of the 14-days, then the 7-day course may be chosen. The researchers collect H.pylori-positive patients who need native therapy. 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 7days or 14days bismuth 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 and patient compliance of each group were calculated. According to therapy, it is randomized into a 7days treatment group and a 14 days treatment group. The two groups of bismuth quadruple regimens are the same, as follows: 7days group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid 14days group: Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid

Official Title
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Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori : A Multicenter Randomized Non-Inferiority Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Procedure: 7days bismuth quadruple
* Procedure: 14 days bismuth quadruple


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-70. Without active hepatitis. Helicobacter pylori infection (either positive for rapid urease test, C13/C14 urea breath 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 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 7 days<br>Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid | Procedure: 7days bismuth quadruple<br>* Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid*7days<br>* Other names: Tegoprazan;|
| Active Comparator: 14 days<br>Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid | Procedure: 14 days bismuth quadruple<br>* Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid*14days<br>* Other names: Tegoprazan;|

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 |