Helicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)

Study Overview
=================
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.

Official Title
-----------------
A Multicenter Clinical Study of Helicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)

Conditions
-----------------
Helicobacter Pylori Infection, Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation, Helicobacter Pylori gyrA Levofloxacin Resistance Mutation, Fecal Drug Resistance Gene Detection

Intervention / Treatment
-----------------
* Diagnostic Test: Detection of fecal samples with diagnostic kit
* Diagnostic Test: 13 C-urea breath test
* Diagnostic Test: Bacterial culture and drug sensitivity test of gastric mucosa samples


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fecal kit group<br>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. | Diagnostic Test: Detection of fecal samples with diagnostic kit<br>* The 23S rRNA mutation site of clarithromycin and gyrA mutation site of levofloxacin were detected by Helicobacter Pylori fecal Gene Mutation Detection Kit.<br>|
| 13 C-urea breath test<br>Patients who meet all the admission and discharge criteria will undergo 13 C-urea breath test. | Diagnostic Test: 13 C-urea breath test<br>* All patients who met the admission and discharge criteria were tested by 13 C-urea breath test.<br>|
| Drug sensitivity test group<br>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. | Diagnostic Test: Bacterial culture and drug sensitivity test of gastric mucosa samples<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fecal gene detection, Levofloxacin resistance gene, Clarithromycin resistance gene