Fecal Drug Resistance Gene Detection, Helicobacter Pylori gyrA Levofloxacin Resistance Mutation, Helicobacter Pylori Infection, Helicobacter Pylori Infection, Susceptibility to
Conditions
Keywords
Fecal gene detection, Levofloxacin resistance gene, Clarithromycin resistance gene
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTDetection of fecal samples with diagnostic kit
The 23S rRNA mutation site of clarithromycin and gyrA mutation site of levofloxacin were detected by Helicobacter Pylori fecal Gene Mutation Detection Kit.
DIAGNOSTIC_TESTSanger Sequencing group
Detection of gyrA and 23S rRNA mutations in H. pylori isolated from Gastric Mucosa by Sanger Sequencing
DIAGNOSTIC_TESTBacterial culture and drug sensitivity test of gastric mucosa samples
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.
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Inclusion criteria
* 1\. patients with Helicobacter pylori infection who need gastroscopy; 2. patients with positive Helicobacter pylori culture in gastric mucosa 3. Helicobacter pylori negative patients
Exclusion criteria
* 1.Patients with insufficient fecal samples collected 2.Patients with contraindication of gastroscopic biopsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of consistency between fecal gene detection kit and Drug sensitivity test | 4 weeks | Compare the positive coincidence rate, negative coincidence rate, total coincidence rate and consistency between stool gene detection kit and drug sensitivity test |
| Evaluation of consistency between fecal gene detection kit and first generation sequencing | 4 weeks | Compare the positive coincidence rate, negative coincidence rate, total coincidence rate and consistency between stool gene detection kit and first generation sequencing |
Countries
China
Outcome results
None listed