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This study aims to compare efficacy and safety of bismuth-containing quadruple therapy(with rabeprazole amoxicillin clarithromycin)of different kinds of bismuth(Bismuth potassium citrate, pectin bismuth capsules, pectin bismuth particles)in H. pylori first-line eradication. It is hypothesized that different bismuth containing quadruple therapies have comparable eradication efficacy and safety. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.
The study will include three phases: screening, treatment and follow-up.Screening: this phase will last a maximum of 28 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 12 and 14.Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bismuth potassium citrate containing quadruple therapy | Active Comparator | Bismuth potassium citrate 220 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days. |
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| Colloidal pectin bismuth capsules containing quadruple therapy | Active Comparator | Colloidal pectin bismuth capsules 200 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days. |
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| Colloidal pectin bismuth particles A quadruple therapy | Active Comparator | Colloidal pectin bismuth particles 150 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days. |
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| Colloidal pectin bismuth particles B quadruple therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bismuth potassium citrate containing quadruple therapy | Drug | Bismuth potassium citrate:given for 14 days at a dose of bismuth potassium citrate 220 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID |
| Measure | Description | Time Frame |
|---|---|---|
| helicobacter pylori eradication | The primary end point of this study is H.pylori eradication,established by negative [13C] urea breath test 28 days after the end of eradication. | 28 days after treatment] |
| Measure | Description | Time Frame |
|---|---|---|
| symptoms effective rates | symptoms effective rates Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom effective rate =#total score before treatment - total score after treatment#/total score before treatment x100%. Total score = frequency + severity.Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3presenting most severe |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache, dizziness, skin rash, other gastrointestinal disorders, pyrexia, cough and back pain. | 14 days of treatment, and 28 days after treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hosipital of Digestive Disease | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34918639 | Derived | Cao Y, Zhang J, Liu Y, Zhang L, Wang L, Wang J, Qi Y, Lv H, Liu J, Huo L, Wei X, Shi Y. The efficacy and safety of different bismuth agents in Helicobacter pylori first-line eradication: A multicenter, randomized, controlled clinical trial. Medicine (Baltimore). 2021 Dec 17;100(50):e27923. doi: 10.1097/MD.0000000000027923. |
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Colloidal pectin bismuth particles 300 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days. |
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| Colloidal pectin bismuth capsules containing quadruple therapy | Drug | Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth capsules 200 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID |
|
| Colloidal pectin bismuth particles A quadruple therapy | Drug | Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 150 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID |
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| Colloidal pectin bismuth particles B quadruple therapy | Drug | Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 300 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID |
|
| 14 days of treatment, and 28 days after treatment |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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