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The purpose of this study was to evaluate the detection ability of Helicobacter pylori 23S rRNA/gyrA gene mutation detection kit (fluorescent PCR fusion curve method) for Helicobacter pylori gene mutation.
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requriment will be included in this simultaneous blind test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal kit group | Collect stool samples from patients who meet the inclusion criteria. DNA was extracted from fecal samples. After that, the extracted DNA was sequenced by first generation sequencing. Finally，the mutation sites of extracted DNA were detected by fecal gene detection kit. |
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| Sanger Sequencing group | Detection of gyrA and 23S rRNA mutations in H. pylori isolated from Gastric Mucosa by Sanger Sequencing |
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| Drug sensitivity test group | Gastroscopy was performed on patients who met the inclusion and exclusion criteria to obtain samples of gastric mucosa. Helicobacter pylori culture and drug sensitivity test were performed on gastric mucosa samples in vitro. Finally, the drug sensitivity test results were collected. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Detection of fecal samples with diagnostic kit | Diagnostic Test | The 23S rRNA mutation site of clarithromycin and gyrA mutation site of levofloxacin were detected by Helicobacter Pylori fecal Gene Mutation Detection Kit. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of consistency between fecal gene detection kit and Drug sensitivity test | Compare the positive coincidence rate, negative coincidence rate, total coincidence rate and consistency between stool gene detection kit and drug sensitivity test | 4 weeks |
| Evaluation of consistency between fecal gene detection kit and first generation sequencing | Compare the positive coincidence rate, negative coincidence rate, total coincidence rate and consistency between stool gene detection kit and first generation sequencing | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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This study will collect patients aged 18-70 years with or without Helicobacter pylori infection who have the need for gastroscopy.
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| Name | Affiliation | Role |
|---|---|---|
| Zhenyu Zhang, Master | Nanjing First Hospital, Nanjing Medical University | Study Chair |
| Yong Xie, Docter | The First Affiliated Hospital of Nanchang University | Study Director |
| Bin lv, Master | The First Affiliated Hospital of Zhejiang Chinese Medical University | Study Director |
| Bin Yang, Doctor | Jiangsu Taizhou People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital, Nanjing Medical University | Nanjing | Jiangsu | 210000 | China | ||
| Jiangsu Taizhou People's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40625832 | Derived | Wei WJ, He BS, Lv B, Yang B, Xie Y, Zhang ZY. Clinical evaluation of a novel H. pylori fecal molecular diagnosis kit (multiplex RT-PCR method) for detecting clarithromycin and fluoroquinolones resistance using stool samples. Front Cell Infect Microbiol. 2025 Jun 23;15:1592612. doi: 10.3389/fcimb.2025.1592612. eCollection 2025. |
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| Sanger Sequencing group | Diagnostic Test | Detection of gyrA and 23S rRNA mutations in H. pylori isolated from Gastric Mucosa by Sanger Sequencing |
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| Bacterial culture and drug sensitivity test of gastric mucosa samples | Diagnostic Test | First, a sample of the patient's gastric mucosa will be obtained through gastroscopy. Then, Helicobacter pylori culture and drug sensitivity test can be carried out. Finally, the resistance data of Helicobacter pylori to clarithromycin and levofloxacin will be obtained. |
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| Taizhou |
| Jiangsu |
| 225300 |
| China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330000 | China |
| The First Affiliated Hospital of Zhejiang Chinese Medical University | Hangzhou | Zhejiang | 310003 | China |