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The goal of this clinical trial is to learn the efficacy of sodium bicarbonate-containing quadruple therapy as the primary treatment for Helicobacter pylori infection. The main questions it aims to answer are:
Can sodium bicarbonate replace bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection? What is the safety and cost-effectiveness of sodium bicarbonate replacing bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection?
Researchers will compare sodium bicarbonate replacing bismuth or clarithromycin in the classic quadruple therapy to see the efficacy of sodium bicarbonate as an alternative to bismuth or clarithromycin in the classic quadruple therapy for the primary treatment of Helicobacter pylori infection.
Participants will: Take Helicobacter pylori treatment drugs for 14 days Recheck 13C-UBT or 14C-UBT breath test 6-8 weeks after eradication treatment Incidence of adverse reactions (AEs) and patient compliance
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Classic quadruple therapy | Active Comparator | Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Clarithromycin 500 mg BID for 14 days |
|
| Quadruple therapy with sodium bicarbonate instead of bismuth | Experimental | Esomeprazole 20 mg BID Sodium bicarbonate 500 mg TID Amoxicillin 1 g BID Clarithromycin 500 mg BID for 14 days |
|
| Quadruple therapy with sodium bicarbonate instead of clarithromycin | Experimental | Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Sodium bicarbonate 500 mg TID for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Classic quadruple therapy | Drug | Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Clarithromycin 500 mg BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter pylori eradication rate | Repeat 13C-UBT or 14C-UBT breath test, negative results (<4.0‰, delta over baseline, 13C-UBT DOB; <100, DPM, 14C-UBT) indicate successful eradication. Patients are not allowed to take PPIs or P-CAB drugs 2 weeks before the breath test, and are not allowed to take antibiotics 4 weeks before the breath test. | 6-8 weeks after eradication treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions (AEs) | Participants' symptoms during treatment, such as nausea, vomiting, diarrhea, rash, belching, abdominal pain, bloating, or other aggravated symptoms, were recorded and divided into three categories based on their impact on daily life: mild (transient, well tolerated), moderate (some discomfort that interferes with daily life), and severe (severe discomfort that adversely affects daily life). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Ye | Contact | 13858168852 | 86 | wzmcyejun@zju.edu.cn |
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| Quadruple therapy with sodium bicarbonate instead of bismuth | Drug | Esomeprazole 20 mg BID Sodium bicarbonate 500 mg TID Amoxicillin 1 g BID Clarithromycin 500 mg BID |
|
| Quadruple therapy with sodium bicarbonate instead of clarithromycin | Drug | Esomeprazole 20 mg BID Bismuth pectin 200 mg BID Amoxicillin 1 g BID Sodium bicarbonate 500 mg TID |
|
| One month after finishing with therapy |
| Compliance of patients | Good compliance was defined as taking at least 80% of the medication. | One month after finishing with therapy |