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The goal of this clinical trial is to evaluate the eradication efficacy and health economic benefits of individualized regimens guided by fecal molecular susceptibility testing with 7-day and 14-day courses in the first-line treatment of Helicobacter pylori infection. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7-day | Experimental |
| |
| 14-day | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7-day fecal molecular susceptibility-guided therapy | Drug | This intervention involves performing polymerase chain reaction (PCR)-based detection of Helicobacter pylori drug resistance genes (including clarithromycin, levofloxacin) from fecal samples. Based on the susceptibility results and penicillin-allergic test, a tailored 7-day triple or quadruple therapy regimen is prescribed, including Tegoprazan , Amoxicillin, Clarithromycin, Levofloxacin, Bismuth Potassium Citrate, Metronidazole, Doxycycline or Minocycline. |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate of Helicobacter pylori | Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value) | 4-8 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events | Any possible adverse events during the treatment period were recorded. | Throughout the treatment period, up to 2 weeks |
| Adherence rate | The proportion of subjects with good adherence. Good adherence was defined as that subjects took more than 80% of the total medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Average cost of each group | Average medical cost related to therapy and followup in each group | Throughout the treatment period, up to 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Chen | Contact | 86-17811921405 | chenqimd@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiaotong University | Shanghai | Shanghai Municipality | 200000 | China | ||
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|
| 14-day fecal molecular susceptibility-guided therapy | Drug | This intervention involves performing polymerase chain reaction (PCR)-based detection of Helicobacter pylori drug resistance genes (including clarithromycin, levofloxacin) from fecal samples. Based on the susceptibility results, a tailored 14-day triple or quadruple therapy regimen is prescribed, including Tegoprazan , Amoxicillin, Clarithromycin, Levofloxacin, Bismuth Potassium Citrate, Metronidazole, Doxycycline or Minocycline. |
|
| Throughout the treatment period, up to 2 weeks |
| Shanghai Jiangong Hospitail. |
| Shanghai |
| Shanghai Municipality |
| China |
|
| Shanghai Tenth People Hospital | Shanghai | Shanghai Municipality | China |
|
| Zhongshan Hospital, Fudan University | Shanghai | China |
|